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Psoriasis

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The App is based on the AAD psoriasis clinical guidelines. Adherence to the guidelines recommendations will not ensure successful treatment in every situation. Furthermore, these guidelines should not be interpreted as setting a standard of care, or be deemed inclusive of all proper methods of care nor exclusive of other methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding the propriety of any specific therapy must be made by the physician and the patient in light of all the circumstances presented by the individual patient, and the known variability and biological behavior of the disease. This guideline reflects the best available data at the time the guideline was prepared. The results of future studies may require revisions to the recommendations in this guideline to reflect new data.

Clinical Recommendations

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Topical Therapies

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Corticosteroids

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Corticosteroids

Indication:
  • Plaque type psoriasis
Dosing:
  • Can be used as mono-therapy 1-2 times daily.
  • Can be combined with other topical agents, UV light and systemic agents
Potency of Topical Steroids:
  • Stoughton-Cornell classification system divides steroids into 7 classes.
Duration of Dosing:
  • Class 1 steroids: available data for 2-4 weeks of treatment
  • Less potent agents: Optimal endpoint unknown
  • Gradual reduction in usage recommended following clinical response; while optimal endpoint is unknown unsupervised continuous use is not recommended
  • For clobetasol and halobetasol maximal weekly use should be 50 gms or less
Short-term Results:
  • Highly potent agents have greater efficacy than less potent agents
  • Vehicle, usage area, patient preference, patient age, and cost alter efficacy
  • See Table 1 for efficacy rates.
Long-term Results:
  • True efficacy and risks associated with long-term use are unknown as most clinical trials are of short duration
  • Tachyphylaxis, while not demonstrated in clinical trials, may affect the long-term results achieved in a given patient.
  • Combination with other topicals and variations in dosing schedules may lessen risk of long-term side effects.
Toxicities:
  • Local - skin atrophy, telangiectasias, striae, purpura, contact dermatitis, rosacea
  • Systemic - hypothalamic-pituitary-adrenal axis suppression may occur with use of medium and high potency topical steroids. Unilateral or bilateral avascular necrosis of the femoral head rarely occurs.
  • Increased intraocular pressure, glaucoma and cataracts have been reported with use around the eye.
  • Risks increase when used with excessive frequency or duration.
  • It is unknown if there is an increased risk of infection with chronic use.
Baseline Monitoring:
  • None
Ongoing Monitoring:
  • Assessment of growth in children using for long term
  • Regular skin checks for all patients on long term therapy to assess for atrophy
Pregnancy:
  • Category C
Nursing:
  • Unknown safety.
Pediatric Use:
  • Because of the increased skin surface/body mass ratio, the risks to infants and children may be higher for systemic effects secondary to enhanced absorption. Growth retardation is also a potential concern.

Vitamin D Analogues

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Vitamin D Analogues

Indication:
  • Plaque type psoriasis
Dosing:
  • Twice daily to affected areas
Efficacy:
  • In two large studies of plaque type psoriasis of the body, 70-74% of patients treated with calcitriol or calcipotriene ointment showed either 75% improvement or marked improvement to clearing as compared with 18-19% of patients treated with placebo. 60% of scalp psoriasis patients treated with calcipotriene solution showed clearance or marked improvement as compared to 17% of placebo patients.
  • Combination of calcipotriene and betamethasone ointment – In a 4 week trial of patients with mild to severe plaque psoriasis - 48% of patients treated with the combination agent achieved absent or mild psoriasis, compared to 16.5% of patients treated with calcipotriene once daily, 26.3% of patients treated with betamethasone once daily, and 7.6% of patients treated with placebo. A 52 week clinical practice usage study showed 70-80% of patients achieving clear or almost clear status with no drug-related serious adverse events such as HPA axis oppression or stria when used on an as needed basis.
  • Use in combination with topical corticosteroids gives added benefit.
Contraindications/Adverse Reactions:
  • Irritation in lesional and peri-lesional skin that is transient.
  • Reversible elevation of serum calcium – more likely to occur in patients treated with greater than 100 g/week.
  • Causes photosensitivity, but no contraindications to combining with UVB phototherapy
  • When using combination calcipotriene/betametasone, the side effects of high potency topical corticosteroids including HPA axis suppression, skin atrophy, among others (see above) may occasionally occur.
Pregnancy and nursing:
  • Category C
  • No information on excretion in breast milk and pregnant and nursing mothers were excluded from clinical studies.
Pediatric use:
  • Appears to be safe

Tazarotene

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Tazarotene

Indication:
  • Plaque type psoriasis
Dosing:
  • Applied once daily.
Efficacy:
  • 50% or more improvement, seen in 63% and 50% of patients treated with tazarotene 0.1% gel and 0.05% gel used once daily for 12 weeks, compared to 31% of patients treated with vehicle.
  • Overall lesional assessment of none,minimal or mild found in 40 – 51% of patients treated with tazarotene 0.1% cream and 0.05% cream used once daily for 12 weeks, compared to 25% of patients treated with vehicle.
  • Best used in combination with topical corticosteroids
Contraindications/Adverse Reactions:
  • Most common side effect is skin irritation in lesional and perilesional skin.
  • Photosensitizing
Pregnancy and nursing:
  • Pregnancy category X
  • Excreted in mammalian milk, but quantity in human milk is unclear.
Pediatric use:
  • No available data in psoriasis patients under age 18; for acne, approved to age 12.

Tacrolimus and Pimecrolimus

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Tacrolimus and Pimecrolimus

Indications:
  • No FDA approved indications for psoriasis. Primary indications for off label use are for facial and intertriginous psoriasis.
Dosing:
  • Applied twice daily to affected areas. No length of course is specified.
Efficacy:
  • Plaque psoriasis – not generally effective
  • Intertriginous and facial psoriasis: 65% of patients treated with tacrolimus 0.1% ointment were clear or almost clear after 8 weeks of therapy compared with 31% of patients treated with placebo. 71% of the patients treated with pimecrolimus 0.1% cream were clear or almost clear after 8 weeks of therapy as compared to 21% of patients treated with placebo.
Contraindications/Adverse reactions:
  • There are no specific contraindications/adverse reactions for psoriasis.
  • Most common side effect for both medications is burning and itching.
  • A controversial lymphoma “black box” warning has been issued by the FDA
Pregnancy and nursing:
  • Category C
  • Tacrolimus and pimecrolimus are found in human milk and are not recommended for nursing mothers.
Pediatric use:
  • Topical tacrolimus (0.03%) and topical pimecrolimus are approved for patients age 2 years or older for atopic dermatitis.

Emolients

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Emolients

Indications:
  • The use of emollients represents an internationally accepted standard adjunctive therapeutic approach to the treatment of psoriasis
Dosing:
  • Applied once to three times daily
Efficacy:
  • Two controlled studies of aloe vera with conflicting results
Contraindications/Adverse reactions:
  • No known contraindications
Pregnancy and nursing:
  • Generally considered safe
Pediatric use:
  • Generally considered safe

Salicylic Acid

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Salicylic Acid

Indication:
  • No specific FDA indication
Dosing:
  • Applied daily
Efficacy:
  • Data is limited on salicylic acid alone
  • Comparator study of tacrolimus and salicylic acid vs tacrolimus alone in small study (n=24) of psoriasis pts with less than 10% BSA, revealed improved efficacy with addition of salicylic acid
  • Comparator study of 408 pts with moderate - severe psoriasis treated with either mometasone and salicylic acid vs mometasone alone for 3 weeks. Psoriasis severity index measure of erythema, induration, and scaling showed the combination of mometasone furoate-salicylic acid to be more effective than mometasone furoate alone.
Contraindications/adverse reactions:
  • Do not combine with other salicylate drugs. Systemic absorption although rare, can occur especially when applied to over 20% of body surface or in patients with abnormal hepatic or renal function. Salicylic acid decreases the efficacy of UVB phototherapy due to a filtering effect and should not be used before UVB phototherapy
Pregnancy/nursing:
  • Appears to be a safe choice for the control of localized psoriasis in pregnancy
Pediatric use:
  • Due to greater risk of systemic absorption and toxicity, salicylic acid should be avoided in children

Anthralin

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Anthralin

Indications:
  • Was important component of psoriasis treatment for many years.
Dosing:
  • Several doses are available. Now commonly used as short contact therapy starting at 1% concentration with increasing concentration over time as tolerated
Efficacy:
  • Limited placebo controlled trial data but as monotherapy, anthralin appears to have lower efficacy than more potent topical corticosteroids or vitamin D derivatives
Contraindications/adverse reactions:
  • Most common side effects are skin irritation and staining of the skin and other touching objects. Due to skin irritation, important to avoid contact with surrounding normal skin
Pregnancy/nursing:
  • Category C
Pediatric use:
  • Use with caution

Coal Tar

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Coal Tar

Indications:
  • Used in the treatment of psoriasis for over 100 years. Although the use of tar products for treatment of localized psoriasis has decreased over time in the US, they are still often used in other countries
Dosing:
  • Many formulations exist
Efficacy:
  • In double blind randomized controlled trial of 324 patients with mild-moderate psoriasis comparing 1% coal tar lotion with 5% coal tar extract, there was better improvement in both PASI score and TSS (total sign score) in patients treated with 1% lotion than in 5% extract
Contraindications/Adverse reactions:
  • Often poorly tolerated by patients due to cosmetic issues including staining of clothes and tar odor.
  • Other potential adverse events include irritant contact dermatitis, folliculitis, and photosensitivity.
  • Coal tar is carcinogenic in animals, but in humans there are no convincing data proving carcinogenicity and epidemiologic studies fail to show increased risk of skin cancer in patients who use coal tar.
Pregnancy and nursing:
  • Risk of topical coal tar used for short periods of time during pregnancy is likely to be small
Pediatric use:
  • Use with caution

Systemic Agents

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Methotrexate

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Methotrexate

Indication:
  • Severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy.
Dosing:
  • Methotrexate is administered as a weekly single oral dose
  • Doses can be increased gradually until an optimal response is achieved.
  • Total dose should not ordinarily exceed 30mg per week.
  • Doses should be reduced to the lowest possible amount of drug needed to achieve adequate control of psoriasis with concomitant topical therapy.
  • A test dose of 2.5 – 5 mg is recommended
Duration of Dosing:
  • Treatment can be continued for as long as is necessary provided there are no meaningful signs of liver or bone marrow toxicity with adequate monitoring.
  • Folic acid supplementation 1-5mg daily by mouth, except for the day of methotrexate dosing, reduces the frequency of side effects.
Therapeutic Results:
  • In the only placebo-controlled trial of methotrexate for psoriasis, 36% of patients treated with 7.5mg orally per week, increased as needed up to 25mg per week, reached PASI 75 after 16 weeks.
Absolute Contraindications:
  • Pregnancy
  • Nursing mothers
  • Alcoholism
  • Alcoholic liver disease or other chronic liver disease
  • Immunodeficiency syndromes
  • Bone marrow hypoplasia, leukopenia, thrombocytopenia or significant anemia
  • Hypersensitivity to methotrexate
Relative Contraindications:
  • Abnormalities in renal function
  • Abnormalities in liver function
  • Active infection
  • Obesity
  • Diabetes mellitus
Toxicity:
  • Elevated LFT’s - Minor elevations of LFTs are common. If elevation exceeds 2x normal, must check more frequently; if exceeds 3x normal, consider dose reduction; if exceeds 5x normal discontinue
  • Anemia, aplastic anemia, leukopenia, thrombocytopenia
  • Interstitial pneumonitis
  • Ulcerative stomatitis
  • Nausea, vomiting, diarrhea
  • Malaise or fatigue
  • Chills and fever
  • Dizziness
  • Decreased resistance to infection
  • Gastrointestinal ulceration and bleeding
  • Photosensitivity (“radiation recall”)
  • Alopecia
Drug Interactions:
  • Hepatotoxic drugs such as barbiturates
  • Acitretin has been used successfully in combination with methotrexate despite the potential for hepatotoxicity from both medications
  • Drugs that interfere with renal secretion of methotrexate such as sulfamethoxazole, NSAIDs, and penicillins.
  • Folic acid antagonists such as trimethoprim.
Liver Biopsy:
  • Low risk patients – at baseline, not necessary
  • First biopsy: 3.5-4g; subsequent biopsies to be considered after 1.5g
  • High-risk patients including history of diabetes, obesity, abnormal LFTs, excessive EtOh ingestion, chronic liver disease, family hex of heritable liver disease.
  • Consider baseline biopsy or at 6 months with subsequent biopsies after 1-1.5 grams
Baseline Monitoring:
  • History and Physical Examination
  • CBC and platelet count
  • BUN, creatinine and LFT’s
  • Liver biopsy is only indicated in patients with a history of significant liver disease
  • Pregnancy test and test for HIV in selected patients.
  • Consider PPD
  • Consider chest x-ray if patient has underlying pulmonary disease
Ongoing Monitoring:
  • CBC and platelet count at varying intervals (initially every 2-4 weeks for first few months and then every 1-3 months depending upon dosage adjustments, symptoms, and previous CBC results.
  • LFT’s at monthly intervals, BUN, creatinine every 2-3 months depending on dosage adjustments, symptoms and previous blood results.
  • Pregnancy test if indicated.
  • Consider liver biopsy in high-risk patients including history of diabetes, obesity, abnormal LFTs, excessive EtOh ingestion, chronic liver disease, family hx of heritable liver disease
  • For those without risk factors, consider liver biopsy in patients with cumulative doses of more than 3.5-4g methotrexate.
  • For patients without risk factors, consider repeat liver biopsies after each subsequent 1.5g dosage, based on LFT’s, risk factors such as diabetes and obesity, or in consultation with a hepatologist.
  • The aminoterminal peptide of procollagen III is used in Europe (but is generally not available in the United States) as a test for hepatic fibrosis, reducing the need for frequent liver biopsies.
Pregnancy:
  • Category X
  • Males and females considering conception should be off methotrexate for 3 months prior to attempting to conceive. Should pregnancy ensue prior to this time period, consider genetic counseling
Nursing:
  • Mothers receiving methotrexate should not breast feed.
Pediatric Use:
  • Methotrexate is approved for the treatment of juvenile rheumatoid arthritis.
  • Low dose methotrexate has been used effectively and safely in children for a variety of dermatologic and rheumatologic disorders.
Psoriatic Arthritis:
  • Although there are only two small controlled trials evaluating methotrexate for psoriatic arthritis that are inadequately powered to assess clinical benefit, methotrexate is often used as the primary agent to treat psoriatic arthritis.

Cyclosporine

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Cyclosporine

Indication:
  • Adult, non-immunocompromised patients with severe, recalcitrant psoriasis (Severe is defined by the FDA as extensive or disabling plaque psoriasis; Recalcitrant is defined by the FDA as those patients who have failed to respond to at least one systemic therapy or in patients for whom other systemic therapies are contraindicated, or cannot be tolerated)
  • Some guidelines suggest use of cyclosporine in moderate to severe psoriasis
  • Efficacy observed in erythrodermic psoriasis, generalized pustular psoriasis and palmoplantar psoriasis
Dosing:
  • 2.5-5.0 mg/kg/day in two divided doses per day
  • Dose adjustments downward (by 0.5 – 1.0 mg/kg) when clearance is achieved or when hypertension or decreased renal function tests are observed
Duration of Dosing:
  • Optimally used as interventional therapy; may be repeated at intervals after a rest period
  • US Approval: 1 year continuous treatment; Non-US: 2 years of continuous treatment
Short-term Results:
  • At 3 and 5 mg/kg/d, 36% and 65%, respectively, achieved a clear or almost clear after 8 weeks
  • After 8-16 weeks, 50-70% of patients achieve PASI 75
Long-term Results
  • Not recommended due to toxicities.
  • Rapid relapse after abrupt discontinuation of cyclosporine
Contraindications
  • Concomitant PUVA or UVB, methotrexate or other immunosuppressive agents, coal tar, history of >200 PUVA treatments or prior radiation therapy
  • Abnormal renal function
  • Uncontrolled hypertension
  • Malignancy
  • Hypersensitivity to cyclosporine
  • Avoid live vaccinations
  • Caution with major infection and poorly controlled diabetes
Toxicity
  • Renal impairment
    • Acute
    • Chronic (increasing glomerular fibrosis with increasing duration of treatment with higher dosages)
  • Hypertension
  • Malignancies
    • Cutaneous
    • Lymphoproliferative
  • Headache, tremor, paresthesia
  • Hypertrichosis
  • Gingival hyperplasia
  • Worsening acne
  • Nausea/vomiting/diarrhea
  • Myalgias
  • Flu-like symptoms
  • Lethargy
  • Hypertriglyceridemia
  • Hypomagnesemia
  • Hyperkalemia
  • Hyperbilirubinemia
  • Increased risk of infection
  • May increase risk of cancer
Drug Interactions (see Table VIII):
  • Inducers/inhibitors of cytochrome P-450 3A4
  • St. John’s Wort decreases cyclosporine concentration
  • Cyclosporine may reduce clearance of digoxin, colchicine, prednisolone, statins (increased risk of rhabdomyolysis)
  • Potassium-sparing diuretics cause hyperkalemia
  • Thiazide diuretics increase nephrotoxicity
  • Killed vaccines may have decreased efficacy
  • Live vaccination is contraindicated
  • NSAID’s
Baseline Monitoring:
  • History and Physical Examination
  • Blood Pressure x 2
  • BUN and Cr x 2
  • Urinalysis
  • Consider PPD
  • LFTs, CBC, lipid profile, magnesium, uric acid and potassium
  • Pregnancy test if indicated

Ongoing Monitoring

  • Every other week during initial 3 months, thereafter at 1 month intervals: Blood pressure, BUN, and Cr
  • Monthly CBC, LFTs, lipid profile, magnesium, uric acid and potassium
  • Pregnancy testing if indicated
Pregnancy:
  • Category C
  • lower birth weight and shorter duration of pregnancy reported in transplant patients.
  • Appears not to be teratogenic in transplant patients
Nursing:
  • Mothers receiving cyclosporine should not breast-feed.
Pediatric Use:
  • Transplant recipients as young as 1 year old have been treated with no unusual adverse events. While safety and efficacy of cyclosporine for children < 18 yrs with psoriasis has not been established, it may be considered in this patient population with severe psoriasis.
Psoriatic Arthritis:
  • There are studies demonstrating the efficacy of cyclosporine for psoriatic arthritis

Acitretin

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Acitretin

Indication:
  • FDA approved for adults with severe plaque type psoriasis
Dosing:
  • 10-50 mg/day given as a single dose
  • Lower doses (25 mg/day or less) often used to minimize side effects, especially in combination regimens
  • When acitretin is added to UV, light dose should be reduced by 30-50%
Short-term Results:
  • Efficacy rates not well defined but are high, based on studies of high dosages that are poorly tolerated
  • Efficacy rates when used in combination with phototherapy are higher
Long-term Results:
  • Not reported
Contraindications:
  • Acitretin is a potent teratogen and must be avoided in women of child-bearing potential
  • Severely impaired liver or kidney function
  • Chronic abnormally elevated blood lipid values
Toxicity:
  • Cheilitis
  • Alopecia
  • Xerosis, pruritus
  • Xerophthalmia, night blindness
  • Dry mouth
  • Paronychia
  • Paresthesias
  • Headache, pseudotumor cerebri
  • Nausea, abdominal pain
  • Joint pain
  • Myalgia
  • Hypertriglyceridemia
  • Abnormal LFT’s
Drug Interactions:
  • Etretinate can be formed with concurrent ingestion of acitretin and ethanol
  • Acitretin may potentiate glucose lowering effect of glibenclamide
  • May interfere with the contraceptive effect of microdosed progestin minipill
  • Acitretin and methotrexate can both cause hepatotoxicity, therefore they should be combined with caution.
  • Acitretin may reduce the protein binding of phenytoin
  • Acitretin and tetracyclines can both increase intracranial pressure. Their combined use should be avoided.
  • Concomitant administration of vitamin A and other oral retinoids with acitretin should be avoided
Baseline Monitoring:
  • History and Physical Examination
  • Lipid profile, CBC, LFT’s, renal function tests
  • Pregnancy test if indicated
Ongoing Monitoring:
  • LFTs, lipid profile at 2 wk intervals for the first 8 weeks, then every 6-12 wks
  • CBC, renal function tests every 3 months
  • Pregnancy test if indicated
Pregnancy:
  • Category X
Nursing:
  • Mothers receiving acitretin should not breast-feed.
Pediatric Use:
  • The safety and efficacy of acitretin in children with psoriasis is not established. High dose, long term oral retinoid use has been associated with ossification of interosseous ligaments and tendons of the extremities, skeletal hyperostoses, decreases in bone mineral density, and premature epiphyseal closure.
Psoriatic Arthritis:
  • Generally thought to be ineffective for psoriatic arthritis

Azathioprine

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Azathioprine

Indication:
  • There is no FDA approved use for psoriasis
Dosing:
  • Thiopurine methyl transferase levels are generally used to guide dosing
  • One suggested daily schedule guided by results of TPMT values
TPMT <5.0 U do not use azathioprine
TPMT 5 -13.7 U 0.5mg/kg max dose
TPMT 13.7 - 19.0 U 1.5mg/kg max dose
TPMT >19.0 U 2.5mg/kg max dose

Alternatively, start at 0.5mg/kg, and monitor for cytopenia. If no cytopenia, can increase dose by 0.5 mg/kg/day after 6-8 wks if necessary and increase by 0.5 mg/kg/day every 4 wks thereafter as needed. Generally dosed at 75 – 150 mg/day

Efficacy:
  • In one study 19/29 pts had >75% improvement but in another smaller study 5/10 pts had >25% improvement
Absolute Contraindications:
  • Allergy to azathioprine
  • Pregnancy or attempting pregnancy
  • Clinically significant active infection
Relative Contraindications:
  • Concurrent use of allopurinol
  • Prior treatment with cyclophosphamide or chlorambucil
Toxicity
  • Bone marrow suppression
  • Malignancies
    • Cutaneous (SCCs)
    • Lymphoproliferative
  • Increased risk of infections
  • GI: nausea, vomiting, diarrhea
  • Hypersensitivity syndrome
  • Pancreatitis
  • Hepatitis
Drug Interactions:
  • Allopurinol – increased risk of pancytopenia (if using concurrently, lower azathioprine dose by 75%)
  • Captopril – may increase risk of anemia and leukopenia
  • Warfarin – may need an increased dose of warfarin
  • Pancuronium- may need an increased dose of this for adequate paralysis
  • Co-trimoxazole - increased risk of hematologic toxicity
  • Rifampicin – decreases azathioprine efficacy, also hepatotoxic
  • Clozapine - increased risk of agranulocytosis
Baseline Monitoring:
  • History and Physical Examination
  • LFTs, CBC/diff, serum chemistry profile, urinalysis, PPD, hepatitis B and C screen.
  • Pregnancy test if indicated
Ongoing Monitoring:
  • CBC/diff twice/month for the first 2 months, monthly for the next 2 months, every 2 months thereafter
  • LFTs monthly for the first 3 months then every 2 months thereafter
  • Biannual physical examination focusing on lymph node exam and skin cancer exam (SCC’s in particular)
  • Pregnancy testing if indicated
Pregnancy and Nursing:
  • Pregnancy Category D
  • Pregnancy and breast-feeding should be avoided during treatment with azathioprine, and patients (including males) must use adequate contraception.
Pediatric Use:
  • No data
Psoriatic Arthritis:
  • A small observational cohort study suggests that azathioprine may be of value in psoriatic arthritis

Fumaric Acid Esters

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Fumaric Acid Esters

Indications:
  • There is no FDA approved use for psoriasis in the US. Fumaric acid esters are approved in Europe.
Dosing:
  • Starting dose -one tablet of FumadermR Increase over the next 8 weeks to a maximum of 6 tablets daily
Short-term Results:
  • Multi-center, randomized, double blind placebo controlled trial of 100 pts showed that after 16 weeks fumarate treated pts reached a mean PASI 50 compared to placebo patients whose PASI was essentially changed
  • Randomized, double blind controlled trial of 143 pts given either fumarates plus calcipotriol or fumarates alone found that pts given combination therapy reached PASI 50 in 3 wks vs those treated with fumarates alone reaching PASI 50 in 9 wks
Long-term Results:
  • Case series of pts treated up to 14 years suggest no increased risk for infections or malignancies.
  • Large, long term follow-up studies are necessary to confirm these observations.
Contraindications:
  • Severe liver disease
  • Severe or chronic gastrointestinal disease
  • Severe or chronic kidney disease
  • Malignancy or a history of malignancy
  • Leukopenia and other hematologic abnormalities
  • Pregnancy
  • Breastfeeding
Toxicity:
  • Gastrointestinal (Abdominal cramps, nausea, diarrhea, fullness and flatulence)
  • Flushing
  • Malaise
  • Fatigue
  • Lymphopenia, leukopenia, eosinophilia
  • Hepatotoxicity and elevated LFT’s
  • Increased cholesterol, triglycerides
  • Increased serum creatinine and potassium, and proteinuria
  • Rare case reports of renal disease but none in the controlled trials
Drug Interactions:
  • Other fumaric acid derivatives, methotrexate, cyclosporine, immunosuppressive drugs and cytostatic drugs may potentiate toxicity
  • Drugs known to cause renal dysfunction
Baseline Monitoring:
  • History and physical examination
  • CBC, platelet counts
  • Chemistry screen
  • Urinalysis
Ongoing Monitoring:
  • CBC, platelet count every other week for the first two months; monthly until month 6, and bimonthly thereafter
  • Serum chemistry and urinalysis every 2 weeks for the first month, then monthly for the first 6 months and bimonthly thereafter
Pregnancy:
  • Not recommended in pregnancy (no FDA pregnancy category because it is not approved in the US)
  • Nursing:
  • There is no data and therefore mothers receiving fumaric acid esters should not breast-feed.
Pediatric Use:
  • No data
Psoriatic Arthritis:
  • One small double blind placebo controlled trial suggested minimal efficacy as evidenced by decreased joint pain and sedimentation rate

Hydroxyurea

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Hydroxyurea

Indication:
  • There is no FDA approved use for psoriasis
Dosing:
  • Initial dose of 500 mg PO BID increasing to up to 3 g/day as tolerated.
  • Weekly dose of 3 - 4.5 g/week has also been utilized
Short-term Results:
  • Efficacy rates vary widely
  • One study showed that 55% of 31 patients had at least a 70% reduction in PASI score (mean treatment time of 36 weeks), while another study comparing hydroxyurea to methotrexate showed a 48% reduction in PASI score after 12 weeks of hydroxyurea.
Long-term Results:
  • One study found that 60% of 85 pts treated for a mean of 16 months had a complete or almost complete clearance
Contraindications:
  • Marked bone marrow depression, including leukopenia, thrombocytopenia or anemia
Toxicity:
  • Bone marrow suppression
  • Gastrointestinal symptoms (stomatitis, anorexia, nausea, vomiting, diarrhea, and constipation)
  • Dermatological reactions (rash, ulceration, dermatomyositis - like skin changes, alopecia)
  • Dysuria may rarely occur
  • Neurological disturbances limited to headache, dizziness, disorientation, hallucinations, and convulsions rarely seen
  • Temporary impairment of renal tubular function accompanied by elevations in serum uric acid, BUN, and creatinine
  • Fever, chills, malaise, edema, asthenia
  • Elevation of hepatic enzymes
  • Pulmonary fibrosis rare
  • Fatal and nonfatal pancreatitis and hepatotoxicity, and severe peripheral neuropathy have been reported in HIV-infected patients who received hydroxyurea in combination with antiretroviral agents.
Drug Interactions:
  • Concurrent use of hydroxyurea and other myelosuppressive agents or radiation therapy may increase the likelihood of bone marrow depression
  • Hydroxyurea may raise the serum uric acid level; dosage adjustment of uricosuric medication may be necessary.
Baseline Monitoring:
  • History and Physical Examination
  • Complete blood count at baseline and weekly until stable dose is achieved
  • Pregnancy test if indicated
Ongoing Monitoring:
  • Complete blood count at monthly intervals
  • Biannual physical examination focusing on lymph node exam and skin cancer exam (SCC’s in particular)
  • Pregnancy testing if indicated
Pregnancy and Nursing:
  • Pregnancy Category D
  • Pregnancy and breast-feeding should be avoided during treatment and patients (including males) must use adequate contraception.
Pediatric Use:
  • No data
Psoriatic Arthritis:
  • No data

Leflunomide

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Leflunomide

Indication:
  • There is no FDA approved use for psoriasis
Dosing:
  • Loading dose of 100 mg/day for 3 days followed by 20 mg/day long term
Short-term Results:
  • In the only randomized controlled trial of 190 pts, 24 wks of leflunomide dosed as above, led to a PASI 75 of 17% vs placebo response of 8% (p =.048)
Long-term Results:
  • Not reported
Contraindications:
  • Patients with hypersensitivity to leflunomide or its metabolites
Toxicity:
  • Most common side effects include nausea, diarrhea, loss of appetite, weight loss, headache, dizziness
  • Less frequent adverse reactions may include severe liver injury, including fatal outcome. Most cases of severe liver injury occur within 6 months of therapy and in pts with multiple risk factors for hepatotoxicity.
  • Rare reports of pancytopenia, agranulocytosis and thrombocytopenia in patients receiving leflunomide. This occurs in patients who have been treated with methotrexate or other immunosuppressive agents, or who had recently discontinued these.
Drug Interactions:
  • Co-administration of leflunomide with methotrexate demonstrates no pharmacokinetic interaction between the two drugs but can lead to an increased risk of hepatotoxicity.
  • When leflunomide is given with rifampin, leflunomide levels are increased
Baseline Monitoring:
  • History and Physical Examination
  • CBC/diff and LFT’s.
  • Pregnancy test if indicated
Ongoing Monitoring:
  • Monthly complete blood count with differential and liver function tests for the first six months and then every 6 – 8 weeks
  • Pregnancy testing if indicated
Pregnancy:
  • Category X
Nursing:
  • Leflunomide should not be used by nursing mothers.
Pediatric Use:
  • No data
Psoriatic Arthritis:
  • In the only randomized controlled study of 190 pts with psoriasis and psoriatic arthritis, 59% of pts treated with leflunomide vs 30% of placebo pts were responders by the PsARC

Mycophenolate Mofetil

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Mycophenolate Mofetil

Indication:
  • There is no FDA approved use for psoriasis
Dosing:
  • 1.0 – 1.5 gm orally two times per day
Short-term Results:
  • 47% mean reduction in PASI at 12 weeks in 23 patients with psoriasis treated with 1.0-1.5 gm bid
  • 47% mean reduction in PASI at 6 weeks in 11 psoriasis patients treated with 1 gm bid for 3 weeks then 0.5 gm bid for 3 more weeks
Long-term Results:
  • No data
Contraindications:
  • Hypersensitivity to mycophenolate mofetil, mycophenolic acid
Toxicity:
  • GI side effects (diarrhea, nausea/vomiting, abdominal cramps). These occur early and decrease with continued use.
  • Hematologic (leukopenia is most common; anemia, thrombocytopenia)
  • Genitourinary (urgency, frequency, dysuria, sterile pyuria).
  • Increased incidence of viral, bacterial and mycobacterial infections
  • Progressive multifocal leukoencephalopathy
  • Hypercholesterolemia, hypophosphatemia, hyperkalemia, hypokalemia
  • Fever and myalgias
  • Headache, insomnia
  • Peripheral edema
  • Hypertension
  • Patients taking mycophenolate mofetil should not be given live attenuated virus vaccines
Drug Interactions:
  • Antacids containing aluminum and magnesium
  • Calcium and iron
  • Cholestyramine
  • Antibiotics including cephalosporins, fluoroquinolones, macrolides, penems, penicillins, sulfonamides inhibit enterohepatic recirculation and decrease mycophenolate mofetil levels
  • High dose salicylates
  • Phenytoin
  • Xanthine bronchodilators
  • Probenecid
  • Acyclovir, ganciclovir, valganciclovir
Baseline Monitoring:
  • History and Physical Examination
  • CBC, platelet counts
  • Chemistry screen, LFT’s
  • Pregnancy test if indicated
Ongoing Monitoring:
  • CBC, platelet count weekly x1 month; then every 2 weeks for 2 months; then monthly thereafter.
  • Monthly chemistry panel and LFT’s
  • Biannual physical examination focusing on lymph node exam and skin cancer exam (SCC’s in particular)
  • Pregnancy testing if indicated
Pregnancy/Nursing:
  • Pregnancy Category D
  • Pregnancy and breast-feeding should be avoided during treatment and patients (including males) must use adequate contraceptive precautions.
Pediatric Use:
  • No data
Psoriatic Arthritis:
  • Case reports suggest improvement

Sulfasalazine

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Sulfasalazine

Indication:
  • There is no FDA approved use for psoriasis
Dosing for Psoriasis:
  • In psoriasis, initial dose of 500 mg PO BID increased to up to 3 -4 g/day as tolerated.
Duration of Dosing:
  • As long as needed. There are no known cumulative toxicities.
Short-term Results:
  • Efficacy rates not well characterized. In the only randomized controlled trial, 8 wks of 3- 4 g/day sulfasalazine led to moderate improvement (global improvement of 30-59%) in 7/17 assessable sulfasalazine pts compared to 1/27 assessable placebo pts)
Long-term Results:
  • Not reported
Contraindications :
  • Patients with intestinal or urinary obstruction, patients with porphyria, patients hypersensitive to sulfasalazine, its metabolites, sulfonamides, or salicylates.
Toxicity:
  • Anorexia, headache, gastrointestinal symptoms (including nausea, vomiting, and gastric distress) and oligospermia can occur in up to one third of patients
  • Less frequent reactions include skin rash, pruritus, urticaria, fever, hemolytic anemia, and cyanosis, which may occur in one in 1/30 patients or less.
Drug Interactions:
  • Reduced absorption of folic acid and digoxin
Baseline Monitoring:
  • History and physical examination
  • CBC/diff and LFT’s
  • Pregnancy test if indicated
Ongoing Monitoring:
  • CBC/diff and LFT’s every other week for the first three months. During the second three months, CBC/diff and LFT’s monthly and thereafter once every three months.
  • Urinalysis and renal function tests should be done periodically
  • Pregnancy testing if indicated
Pregnancy:
  • Category B
Nursing:
  • Sulfonamides are excreted in the milk. In the newborn, they compete with bilirubin for binding sites on the plasma proteins and may thus cause kernicterus.
Pediatric Use:
  • No data
Psoriatic Arthritis:
  • In the largest trial of sulfasalazine for psoriatic arthritis, after 36 weeks of treatment with 2 gm/day, 58% of pts given sulfasalazine compared to 45% of pts given placebo achieved PsARC

Tacrolimus

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Tacrolimus

Indication:
  • There is no FDA approved use for psoriasis
Dosing for Psoriasis:
  • 0.05 – 0.15 mg/kg
Duration of Dosing:
  • Unknown
Short-term Results:
  • Efficacy rates are poorly characterized. Pts dosed at 0.05 mg/kg showed no difference from placebo at 3 wks. When dosed at 0.10 – 0.15 mg/kg, by 9 wks there was a statistically significant improvement in PASI compared to placebo
Long-term Results:
  • Not reported
Contraindications:
  • Patients with hypersensitivity to tacrolimus or its metabolites.
Side effects (profile similar to cyclosporine):
  • Most common side effects include tremor, headache, nausea, diarrhea, hypertension and abnormal renal function tests
  • Less common side effects include hyperglycemia, hyperkalemia, elevated LFTs, anemia, leukocytosis, dyspnea, fever, arthralgias, edema, diabetes, insomnia, paresthesias,
Drug Interactions:
  • Numerous drug interactions as tacrolimus is metabolized by cytochrome P450 system
  • Do not give tacrolimus and cyclosporine together
Baseline Monitoring:
  • History and Physical Examination
  • CBC/diff, renal and LFT’s.
  • Pregnancy test if indicated
Ongoing Monitoring (proper frequency is not established):
  • Blood pressure
  • Serum chemistry
  • Renal function
  • Liver function
  • Pregnancy testing if indicated
Pregnancy:
  • Category C
Nursing:
  • Tacrolimus should not be used by nursing mothers.
Pediatric Use:
  • No data
Psoriatic Arthritis:
  • Case reports suggest improvement

6-Thioguanine

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6-Thioguanine

Indication:
  • There is no FDA approved use for psoriasis
Dosing:
  • Start at 80 mg two times per week. Increase by 20 mg every 2-4 weeks. Maximum dose is 160 mg 3 times per week.
Short-term Results:
  • Open label trial of 14 pts treated with pulse dosing followed by maintenance dosage (120 mg twice a week to 160 mg three times per week). Of 11 pts who became longer term responders, 6/11 showed a response after 2-4 weeks
Long-term Results
  • 76 patients followed for over one month. At 24 months, 58% were effectively maintained.
  • Has been safely used up to 145 months
  • Another study showed 14/18 patients had 90% improvement
Contraindications:
  • Pre-existing liver disease
  • Immunosuppression
  • Anemia, leukopenia and/or thrombocytopenia
Toxicity:
  • Myelosuppression
  • Liver toxicity from hepatic venoocclusive disease
  • Increased ALT and AST
  • Hyperuricemia
  • Photodermatitis
  • Taste changes
  • Gastroesophageal reflux, gastric ulcers
  • Headache
  • Nausea/Vomiting
  • Aphthous ulcers
  • Fatigue
  • Non-melanoma skin cancer
  • Multiple warts, herpes zoster
  • Drug Interactions
  • Aminosalicylate derivatives (olsalazine, mesalazine, or sulfasalazine) may inhibit TPMT.
Baseline Monitoring:
  • History and Physical Examination
  • CBC, platelet count, chemistry screen, LFT’s, Hepatatis B and C, PPD
  • Pregnancy test if indicated
Ongoing Monitoring:
  • CBC and platelet count every 2-4 weeks; Serum chemistry every 3 months
  • Biannual physical examination focusing on lymph node exam and skin cancer exam (SCC’s in particular)
  • Pregnancy testing if indicated
Pregnancy/Nursing:
  • Pregnancy Category D
  • Pregnancy and breast-feeding should be avoided during treatment, and patients (including males) must use adequate contraception.
Pediatric Use:
  • No data
Psoriatic Arthritis:
  • No data
  • Phototherapy and Photochemotherapy

Phototherapy and Photochemotherapy

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UVB (broad and narrowband)

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UVB (broad and narrowband)

Indication:

Generalized psoriasis (including guttate) unresponsive to topicals

Dosing:
  • BB:
    • Initial dosing according to skin type (20-60 mJ/cm2) or MED (50% of MED).
    • Subsequent dosage increase by 5-30 mJ/cm2 or 25% or less of the initial MED.
    • Treatment 3-5 times weekly.
  • NB:
    • Initial dosing according to skin type (130 to 400 mJ/cm2) or MED (50% of MED).
    • Subsequent dosage increase by 15- 65 mJ/cm2 or 10% or less of the initial MED.
    • Treatment 3-5 times weekly.
Duration of Treatment:
  • BB:
    • Initial improvement often occurs within 4 weeks of therapy
    • A single course is 20-25 treatments
    • Maintenance therapy may prolong remission
  • NB:
    • Response observed at 8 to 10 treatments.
    • A single course is 15 to 20 treatments.
    • Maintenance therapy may prolong remission.
Short-term results (clearance):
  • BB:
    • Average of 20-25 treatments to induce clearance
  • NB:
    • More effective than BB-UVB, clearance within 2 weeks may be seen.
    • Average of 15-20 treatments to achieve clearance
Long-term results (remission):
  • BB: Remission rate of 5% after 1 year
  • NB: Remission rate of 38% after 1 year
Contraindications:
  • Patients with known lupus erythematosus, or xeroderma pigmentosum
Caution should be exercised in:
  • Patients with skin types I and II who tend to burn easily
  • Those with a history of arsenic intake or previous treatment with ionizing radiation therapy
  • Those with a history of melanoma or multiple non-melanoma skin cancers
  • Those with any medical condition that is severe enough that the patient cannot tolerate heat or prolonged standing in the light box.
Toxicity:
  • Acute:
  • Erythema
  • Pruritus
  • Burning
Long Term:
  • Photo-aging, lentigines, telangectasias
  • Theoretical risk of photo-carcinogenesis.
  • Advise use of protective goggles and genital shields during treatment
Drug interactions:
  • Cautious use with other photosensitizing medications.
  • When used in conjunction with systemic retinoids, the dose of both retinoids and UVB may need to be lowered.
Baseline Monitoring:
  • Full body skin check before initiation of therapy.
Ongoing Monitoring:
  • Regular full skin exam to monitor signs of photo-aging, pigmentation and cutaneous malignancies.
Pregnancy:
  • Generally considered safe (expert opinion)
Nursing:
  • Generally considered safe (expert opinion)
Pediatric use:
  • No adequate study. May be used with caution in individuals younger than 18 years of age.
Psoriatic arthritis:
  • No studies

Topical Targeted Phototherapy

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Topical Targeted Phototherapy

Indications:
  • Adult and Pediatric Patients with Mild, Moderate or Severe Psoriasis with less than 10% BSA involvement.
Dosage:
  • Initial dose depends on the individual’s skin type (including formal MED testing), plaque characteristics and thickness. (500 to 900 mJ/cm2 for the XTRAC ®)
  • Subsequent doses adjusted according to clinical response and/or side effects.
Duration of Treatment:
  • Dosing 2-3x a week until the patient is clear, usually an average of 10-12 treatments are needed.
Short-term Results:
  • Initial response within 8-10 treatments depends on multiple factors such as device utilized, protocol used, lesion characteristics and site.
Long-term Results:
  • Mean remission times of 3.5 – 6 months
Caution should be exercised:
  • In patients with photosensitivity disorders.
Toxicity:
  • Erythema
  • Hyperpigmentation
  • Blistering, particularly with higher doses.
Drug Interactions:
  • May need to lower dosing based upon presence of photosensitizing medications (Note: the action spectrum of most photosensitizing medications is in the UVA range)
Baseline Monitoring:
  • None
Ongoing Monitoring:
  • For efficacy and for burning
Pregnancy:
  • No studies in pregnancy have been performed but expert opinion is that it is safe
Nursing:
  • No studies in nursing mothers have been performed but expert opinion is that it is safe to be used.
Pediatric Use:
  • No large scale studies in children have been performed but expert opinion is that it is safe to be used.
Psoriatic Arthritis:
  • No studies

Systemic Psoralen plus UVA

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Systemic Psoralen plus UVA

Indications:
  • Adults with generalized psoriasis who are resistant to topical therapy.
Dosing:
  • 8-methoxypsoralen (Oxsoralen Ultra), 0.4-0.6 mg/kg, taken 1-2 hour before exposure to UVA.
  • Other available forms of psoralen include 5-methoxypsoralen and trimethylpsoralen
  • UV protective eye wear should be worn when outdoors for 12 hours post-ingestion
  • Treatment 2-3 times weekly.
Duration of Treatment:
  • Initial improvement frequently seen within 1 month of therapy
  • A single course is 20-25 treatments
  • May be repeated as indicated.
Short-term results:
  • 89% clearing with an average of 25 treatments in the US and 20 treatments in Europe
  • 11.6 weeks to clear in US studies compared to 5.3 weeks to clear in European studies
Long-term results:
  • Once clearance has been achieved, maintenance treatment may or may not be used
  • Remission times: 3-12 months.
Contraindications:
  • Patients with known lupus erythematosus, porphyria, or xeroderma pigmentosum
Caution should be exercised:
  • In patients with skin types I and II who tend to burn easily
  • Those with a history of arsenic intake or previous treatment with ionizing radiation therapy
  • Those with a history of melanoma or multiple non-melanoma skin cancers
  • Those with any medical condition that is severe enough that the patient cannot tolerate heat or prolonged standing in the light box
  • Those with severe liver disease that could lead to toxic levels of psoralens
  • Possibly those who have been treated with cyclosporine or methotrexate
  • Patients who are pregnant or nursing.
Toxicity:
  • Acute:
    • Nausea and vomiting are common
    • Dizziness and headache are rare
    • Erythema (peaks at 48-96 hrs)
    • Pruritus
    • Tanning (starts 1 wk after PUVA)
    • Blisters, photo-onycholysis, melanonychia
  • Chronic:
    • Photo-carcinogenesis (SCC, BCC and possible melanoma)
    • Increased risk of photo-carcinogenesis in Caucasians with skin types 1-3 after 200 treatments. This risk not present for non-Caucasians.
    • Photo-aging and lentigines are common, especially in patients of skin types 1-3 and are cumulative UVA dose dependent
Drug interactions:
  • Caution when the patient is taking other photosensitizing medication
  • Should decrease the UVA dose by one-third if patient is started on oral retinoids while receiving PUVA.
Baseline monitoring:
  • Skin cancer screening
  • Eye examination. However, recent evidence demonstrates no increased risk of cataract in patients who receive PUVA.
  • If indicated by history:
    • ANA panels (anti-Ro/La antibodies)
    • Liver enzymes
Ongoing monitoring:
  • Regular full skin exam due to potential increased risk of photo-carcinogenesis in Caucasians.
  • In patients who are non-compliant with eye protection, yearly eye exam
Pregnancy:
  • Category C
Nursing:
  • Contraindicated for a period of 24 hours after ingesting psoralen
Pediatric use:
  • No studies. May be used with caution in individuals younger than 18 years of age
Psoriatic arthritis:
  • No studies

Topical Psoralen plus UVA

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Topical Psoralen plus UVA

Indications:
  • Topical PUVA for adults with psoriasis of palms and soles.
  • Bath PUVA for adults and children with generalized psoriasis.
Dosing:
  • Topical:
    • Use 0.1% 8-methoxypsoralen in emollient and treat 2-3 times per week.
    • Apply 30 minutes before UVA
    • Start at 0.25 – 0.5 J/cm2, increase by 0.25 – 0.5 J/cm2
  • Bath:
    • 50mg of 8-methoxypsoralen (Oxsoralen Ultra) in 100L water
    • 20-30 min pre-exposure
    • Schedule similar to oral PUVA
Duration of Treatment:
  • May take 30 treatments to have noticeable response
  • A single course usually is 30-40 treatments
  • May be repeated as indicated
Short-term results:
  • Clinically is beneficial
Long-term results:
  • Once clearance has been achieved, maintenance treatment may be used
  • Remission 3-12 months
Contraindications:
  • Patients with known lupus erythematosus, porphyria, or xeroderma pigmentosum
Caution should be exercised:
  • In patients with skin types I and II who tend to burn easily
  • Those with a history of arsenic intake or previous treatment with ionizing radiation therapy
  • Those with a history of melanoma or multiple non-melanoma skin cancers
  • Patients who are pregnant or nursing.
Toxicity:
  • Acute: Erythema, blistering, hyperpigmentation
  • Chronic: No increased risk of skin cancer demonstrated
Drug interactions:
  • None
Baseline monitoring:
  • None
Ongoing monitoring:
  • For efficacy and monitor for burning
Pregnancy:
  • Category C
Nursing:
  • No data available
Pediatric use:
  • Safe provided patient can follow instructions, however no systemic absorption studies have been performed
Psoriatic arthritis:
  • No studies 

Biologics for Psoriasis

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Alefacept

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Alefacept

Indication:
  • moderate to severe psoriasis.
Dosing:
  • 15 mg every week given as an intramuscular injection for 12 weeks, with a 12 week follow-up non-treatment period
Short Term Results:
  • 21% of patients achieved a PASI 75 at week 14
Long Term Results:
  • Associated with long remissions in a subset of responders.
  • Prior response to alefacept is a likely marker of future treatment response. Thus, patients responding to the first course of therapy may be treated long-term with repeated 12-week courses of alefacept – at a minimum of 24 week intervals.
Toxicity:
  • Excellent safety profile in clinical trials.
Baseline Monitoring:
  • CD4 count
Ongoing Monitoring:
  • Biweekly CD4 count required
  • Hold dose for counts <250
Pregnancy:
  • Category B
Contraindications:
  • HIV infection

Ustekinumab

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Ustekinumab

Indications:
  • moderate - severe psoriasis
Dosing:
  • 45 mg of ustekinumab at baseline, 4 weeks and every 12 weeks in those < 100 kg, and 90 mg of ustekinumab at the same intervals for those > 100 kg.
Short term efficacy:
  • PASI 75 in 67% at 12 weeks.
Long term efficacy:
  • PASI 75 maintained in 87% of patients at 52 weeks who attained PASI 75 at week 12.
Toxicities:
  • Occasional injection site reactions.
  • Rare reports of serious infections and malignancies including skin cancers.
  • Rare reports of major adverse cardiovascular events (MACE).
Baseline Monitoring (similar to other biologic agents):
  • PPD is required
  • LFT, CBC and hepatitis profile
Ongoing Monitoring:
  • Periodic history and physical examination recommended while on treatment.
  • Yearly PPD, and periodic CBC and LFT.
Pregnancy:
  • Category B

TNF Inhibitors

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General Recommendations

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General Recommendations

Anti-TNF agents are contraindicated in patients with active, serious infections.

Tuberculosis testing (PPD) should be performed on all patients who will be treated with TNF inhibitors as there are reports of tuberculosis reactivation in patients treated with this class of drug.

Do not use with live vaccines; biologically inactive or recombinant vaccines may be considered, although the immune response of these vaccines could be compromised.

Since there is an association between anti-TNF therapy and demyelinating diseases {i.e. multiple sclerosis (MS)} TNF inhibitors should not be used in patients with MS or other demyelinating diseases. First degree relatives of patients with MS have an increased risk of developing MS, with a sibling relative risk of between 18 and 36, evidence strongly suggesting that TNF inhibitors should not be used in first degree relatives of patients with MS.

Since there have been reports of new onset and worsening of congestive heart failure (CHF) in patients treated with TNF inhibitors, caution should be used when considering TNF inhibitor use in patients with CHF. It is recommended that patients with New York Heart Association Class 3 or 4 CHF avoid all use of TNF inhibitors and patients with Class 1 or 2 CHF undergo echocardiogram testing. If the ejection fraction of these patients is less than 50%, then TNF inhibitor treatment should potentially be avoided.

Hepatitis B reactivation following treatment with TNF inhibitors has been reported. In the appropriate clinical setting, patients should be screened for hepatitis B infection.

Adalimumab

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Adalimumab

Indications:
  • moderate/severe psoriatic arthritis, moderate to severe psoriasis, adult and juvenile rheumatoid arthritis (as young as age 4), ankylosing spondylitis, and Crohn’s disease.
Dosing for psoriasis:
  • 80mg the first week, 40 mg the second week, followed by 40mg every other week given subcutaneously.
Short Term Results:
  • 80% of patients achieve PASI 75 at 12 weeks.
Long Term Results:
  • 68% of patients achieve PASI 75 at 60 weeks.
  • Small percentage of patients lose efficacy with continued use.
Toxicities:
  • Moderately painful injection site reactions are noted.
  • Rare reports of serious infections (i.e., tuberculosis and opportunistic infections) and malignancies.
  • There are rare reports of drug-induced, reversible side effects including lupus without renal or CNS complications, cytopenias, MS as well as exacerbation of and new onset of CHF.
Baseline Monitoring:
  • PPD is required.
  • Liver function tests, CBC, and hepatitis profile.
Ongoing Monitoring:
  • Periodic history and physical exam are recommended while on treatment.
  • Consider a yearly PPD, and periodic CBC and liver function studies.
Pregnancy:
  • Category B.

Etanercept

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Etanercept

Indications:
  • moderate to severe psoriasis, moderate/severe psoriatic arthritis, adult and juvenile rheumatoid arthritis (as young as age 4), and ankylosing spondylitis.
Dosing:
  • 50mg twice weekly given subcutaneously for 3 months followedby 50 mg once weekly.
Short Term Results:
  • 49% of patients given 50 mg twice weekly achieved a PASI 75 at 12 weeks
  • 34% of patients given 25 mg twice weekly achieved a PASI 75 at 12 weeks.
Step-Down Results:
  • 54% of patients whose dose was decreased from 50 mg twice weekly to 25 mg twice weekly achieved a PASI 75 at 24 weeks
  • 45% of patients whose dose remained at 25 mg twice weekly achieved a PASI 75 at 24 weeks.
Toxicities:
  • Mildly pruritic injection site reactions may occur.
  • Rare cases of serious infections (i.e.,. tuberculosis) and malignancies.
  • There are also rare cases of drug-induced, reversible side effects including lupus without renal or CNS complications, cytopenias, MS, as well as exacerbation and new onset of CHF.
Baseline Monitoring:
  • PPD, LFT, and CBC
Ongoing Monitoring:
  • Periodic history and physical exam are recommended while on treatment.
  • Consider yearly PPD, and periodic CBC and liver function studies
Pregnancy:
  • Category B.
Contraindications:
  • Sepsis

Infliximab

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Infliximab

Indications:
  • severe psoriasis, moderate/severe psoriatic arthritis, adult rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis and Crohn’s disease.
Dosing:
  • 5mg/kg dose infusion schedule at weeks 0, 2, 6 and then every 6-8 weeks. Dose and interval of infusions may be adjusted as needed.
Short Term Response:
  • 80% of patients achieved a PASI 75 at week 10
  • 50% PASI improvement noted by 2nd week.
Long Term Response:
  • 61% of patients achieved a PASI 75 at week 50.
Toxicities:
  • Infusion reactions and serum sickness can occur - more commonly in patients who have developed antibodies.
  • The incidence of infusion reactions may be reduced by concurrent administration of methotrexate.
  • Rare cases of serious infections (i.e., tuberculosis) and malignancies including hepatosplenic T-cell lymphoma (in children).
  • There are rare reports of drug-induced, reversible side effects including lupus without renal or CNS complications, cytopenias, MS as well as exacerbation of and new onset of CHF.
Baseline Monitoring:
  • PPD is required.
  • LFT’s, CBC, and hepatitis profile.
Ongoing Monitoring:
  • Periodic history and physical exam are recommended while on treatment.
  • Consider a yearly PPD, and periodic CBC and liver function studies.
Pregnancy:
  • Category B
Contraindications:
  • Infliximab at doses of greater than 5 mg/kg should not be given to patients with New York Heart Association Functional Class Type 3 or 4 CHF.

Biologics for Psoriatic Arthritis

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Adalimumab

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Adalimumab

Indications:
  • Moderate/severe psoriatic arthritis, moderate/severe psoriasis, adult and juvenile rheumatoid arthritis (as young as age 4), ankylosing spondylitis, and adult Crohn’s disease.
Dosing for Psoriatic Arthritis:
  • 40mg every other week subcutaneously
Response:
  • ACR 20 at week 12 is 58%
Toxicities:
  • Moderately painful injection site reactions are noted.
  • Rare reports of serious infections (i.e., tuberculosis and opportunistic infections) and malignancies.
  • There are rare reports of drug-induced, reversible side effects including lupus without renal or CNS complications, cytopenias, MS as well as exacerbation of and new onset of CHF.

Etanercept

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Etanercept

Indications:
  • Moderate/severe psoriatic arthritis, moderate to severe psoriasis, adult and juvenile rheumatoid arthritis (as young as age 4), and ankylosing spondylitis.
Dosing for Psoriatic Arthritis:
  • 25mg twice weekly or 50 mg once weekly given subcutaneously
Response:
  • ACR 20 at 12 weeks is 59%
Toxicities:
  • Mildly pruritic injection site reactions may occur.
  • Rare cases of serious infections (i.e.,. tuberculosis) and malignancies.
  • There are also rare cases of drug-induced, reversible side effects including lupus without renal or CNS complications, cytopenias, MS, as well as exacerbation and new onset of CHF.
Baseline Monitoring:
  • PPD, LFT, and CBC
Ongoing Monitoring:
  • Periodic history and physical exam are recommended while on treatment.

Golimumab

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Golimumab

Indications:
  • moderate - severe psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis
Dosing for Psoriatic Arthritis:
  • 50 mg every 4 weeks subcutaneously.
Efficacy for Psoriatic Arthritis:
  • ACR 20 - 51% at wk 14.
Toxicities:
  • Occasional injection site reactions.
  • Rare reports of serious infections and malignancies.
  • Although there are rare reports of drug-induced reversible side effects including lupus without CNS or renal complications, cytopenias, multiple sclerosis, and exacerbation as well as new onset congestive heart failure with the other three TNF inhibitors, there have been no reports of these reactions with golimumab to date. However, golimumab is a TNF inhibitor and it should be used cautiously.
Baseline Monitoring:
  • PPD is required
  • LFT and CBC
Ongoing Monitoring:
  • Periodic history and physical examination recommended while on treatment.
  • Consider a yearly PPD, and periodic CBC and LFT.
Pregnancy:
  • Category B

Infliximab

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Infliximab

Indications:
  • Moderate/severe psoriatic arthritis, severe psoriasis, adult rheumatoid arthritis, ankylosing spondylitis, and Crohn’s disease (pediatric and adult).
Dosage for Psoriatic Arthritis:
  • 5mg/kg given intravenously at weeks 0, 2, 6 and then every 6 - 8 weeks. Dose and interval of infusions may be adjusted as needed.
Response:
  • ACR 20 at week 14 is 58%
Toxicities:
  • Infusion reactions and serum sickness can occur - more commonly in patients who have developed antibodies.
  • The incidence of infusion reactions may be reduced by concurrent administration of methotrexate.
  • Rare cases of serious infections (i.e., tuberculosis) and malignancies including hepatosplenic T-cell lymphoma (in children). There are rare reports of drug-induced, reversible side effects including lupus without renal or CNS complications, cytopenias, MS as well as exacerbation of and new onset of CHF.
Baseline Monitoring:
  • PPD is required.
  • LFT’s, CBC, and hepatitis profile.
Ongoing Monitoring:
  • Periodic history and physical exam are recommended while on treatment.
  • Consider a yearly PPD, and periodic CBC and liver function studies.

References

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References

Menter A, Gottlieb A, Feldman SR, Van Voorhees AS, Leonardi CL, Gordon KB, Lebwohl M, Koo JY, Elmets CA, Korman NJ, Beutner KR, Bhushan R. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008 May;58(5):826-50.

Gottlieb A, Korman NJ, Gordon KB, Feldman SR, Lebwohl M, Koo JY, Van Voorhees AS, Elmets CA, Leonardi CL, Beutner KR, Bhushan R, Menter A. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol. 2008 May;58(5):851-64.

Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, Gottlieb A, Koo JY, Lebwohl M, Lim HW, Van Voorhees AS, Beutner KR, Bhushan R; American Academy of Dermatology. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol. 2009 Apr;60(4):643-59.

Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, Gottlieb AB, Koo JY, Lebwohl M, Lim HW, Van Voorhees AS, Beutner KR, Bhushan R. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 4. Guidelines of care for the management and treatment of psoriasis with traditional systemic agents. J Am Acad Dermatol. 2009 Sep;61(3):451-85.

Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, Gottlieb A, Koo JY, Lebwohl M, Lim HW, Van Voorhees AS, Beutner KR, Bhushan R. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 5.Guidelines of care for the treatment of psoriasis with phototherapy and photochemotherapy. J Am Acad Dermatol. 2010 Jan;62(1):114-35.

Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, Gottlieb A, Koo JY, Lebwohl M, Leonardi CL, Lim HW, Van Voorhees AS, Beutner KR, Ryan C, Bhushan R. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011 Jul;65(1):137-74.

Guide to Topical Therapy

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Fingertip Unit

The fingertip unit and how to assess quantity of topical agents needed to cover a given body surface area.

Fingertip Unit

ONE FINGERTIP UNIT = APPROXIMATELY 500 MG

Area to be Treated Units1 Area2
Scalp 3 6%
Face and Neck 2.5 5%
One Hand (Front and Back) Including Fingers 1 2%
One Entire Arm Including Entire Hand 4 8%
Elbows (Large Plaque) 1 2%
Both Soles 1.5 3%
One Foot (Dorsum and Sole) Including Toes 1.5 3%
One Entire Leg Including Entire Foot 8 16%
Buttocks 4 8%
Knees (Large Plaque) 1 2%
Trunk (Anterior) 8 16%
Trunk (Posterior) 8 16%
Genitalia 0.5 1%

1Unit = Number of Fingertip Units
2Area = Approximate Body Surface Area (in %)

Efficacy rates

The efficacy of different classes of topical corticosteroids for the treatment of psoriasis based on available evidence.

Class of topical steroid (1-7) Range of efficacy rates
Class 1 (superpotent) 58 - 92%
Class 2 (potent) 68 - 74%
Class 3, 4 (mid and upper midstrength) 68 - 72%
Class 5, 6, 7 (least potent, mild strength and lower midstrength) 41 - 83%

References

Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, Gottlieb A, Koo JY, Lebwohl M, Lim HW, Van Voorhees AS, Beutner KR, Bhushan R; American Academy of Dermatology. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol. 2009 Apr;60(4):643-59.

Guide for Methotrexate Treatment

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RISK FACTORS FOR HEMATOLOGIC TOXICITY FROM METHOTREXATE

RISK FACTORS FOR HEPATOTOXICITY FROM METHOTREXATE

MONITORING FOR HEPATOTOXICITY IN PATIENTS WITH NO RISK FACTORS FOR HEPATOTOXICITY

MONITORING FOR HEPATOTOXICITY IN PATIENTS WITH RISK FACTORS FOR HEPATOTOXICITY

MEDICATIONS THAT MAY INCREASE METHOTREXATE TOXICITY

Nonsteroidal Anti-Inflammatory Drugs
  • Salicylates
  • Naproxen
  • Ibuprofen
  • Indomethocin
  • Phenylbutazone
Antibiotics
  • Trimethoprim/sulfamethoxazole
  • Sulfonamides
  • Penicillins
  • Ciprfloxacin
Others
  • Barbiturates
  • Colchicine
  • Dipyramidole
  • Ethanol
  • Phenytoin
  • Sulfonylureas
  • Furosemide
  • Thiazide diuretics

RELATIVE CONTRAINDICATIONS FOR THE USE OF METHOTREXATE

RECOMMENDATIONS FOR METHOTREXATE

REFERENCES

  1. Kalb RE, Strober B, Weinstein G, Lebwohl M. Methotrexate and psoriasis: 2009 National Psoriasis Foundation Consensus Conference. J Am Acad Dermatol 2009;60:824-37.
  2. Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, Gottlieb AB, Koo JY, Lebwohl M, Lim HW, Van Voorhees AS, Beutner KR, Bhushan R Guidelines of care for the management of psoriasis and psoriatic arthritis: section 4. Guidelines of care for the management and treatment of psoriasis with traditional systemic agents. J Am Acad Dermatol. 2009 Sep;61(3):451-85.

Phototherapy/Photochemotherapy Dosing Guidelines

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Dosing Guidelines for Broadband UVB

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According to Skin Type

Administered 3-5 times a week
Skin Type Initial UVB dose mJ/cm2 UVB Increase After Each Treatment mJ/cm2
Type I 20 5
Type II 25 10
Type III 30 15
Type IV 40 20
Type V 50 25
Type VI 60 30

According to Minimal Erythema Dose

Administered 3-5 times a week
Initial UVB 50% of the MED
Treatment 1 -10 Increase by 25% of the initial MED
Treatment 11-20 Increase by 10% of the initial MED
Treatment 21 and after As ordered by physician

If subsequent treatments are missed for

4-7 days Keep dose same
1-2 weeks Decrease the dose by 50%
2-3 weeks Decrease the dose by 75%
3-4 weeks Start over

References

  1. Adapted with permission from Zanolli MD, Feldman SR. Phototherapy treatment protocols for psoriasis and other phototherapy responsive dermatoses. 2nd ed. New York: Informa Healthcare; 2004.
  2. Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, Gottlieb A, Koo JY, Lebwohl M, Lim HW, Van Voorhees AS, Beutner KR, Bhushan R. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 5. Guidelines of care for the treatment of psoriasis with phototherapy and photochemotherapy. J Am Acad Dermatol. 2010 Jan;62(1):114-35.

Dosing Guidelines for Narrowband UVB

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According to Skin Type

Administered 3-5 times a week
Skin Type Initial UVB dose mJ/cm2 UVB Increase After Each Treatment mJ/cm2 Maximum Dose mJ/cm2
Type I 130 15 2000
Type II 220 25 2000
Type III 260 40 3000
Type IV 330 45 3000
Type V 350 60 5000
Type VI 400 65 5000

Since there is a broad range of MED for NB-UVB by skin type, MED testing is generally recommended.

It is critically important to meter the UVB machine once weekly. UVB lamps steadily lose power. If the UV output is not periodically measured and the actual output calibrated into the machine, the clinician may have the false impression that the patient can be treated with higher doses when the machine is actually delivering a much lower dose than the number entered.

According to Minimal Erythema Dose

Administered 3 times a week
Initial UVB 50% of the MED
Treatment 1 -20 Increase by 10% of the initial MED
Treatment 21 and after Increase as ordered by physician

If subsequent treatments are missed for:

4-7 days Keep dose same
1-2 weeks Decrease the dose by 25%
2-3 weeks Decrease the dose by 50% or start over
3-4 weeks Start over

Maintenance Therapy for NB-UVB after >95% clearance

1x/week NB-UVB for 4 weeks Keep the dose the same
1x/2 weeks NB-UVB for 4 weeks Decrease dose by 25%
1x/4 weeks NB-UVB 50 % of highest dose

The minimum frequency of phototherapy sessions required per week for successful maintenance as well as the length of maintenance period varies tremendously between individuals. The above table represents the most ideal situation where the patient can taper off phototherapy. In reality, many patients require once a week NB-UVB phototherapy indefinitely for successful long term maintenance.

References

  1. Adapted with permission from Do A, Koo J. Initiating narrow-band UVB for the treatment of psoriasis: how to do MED skin testing. Psoriasis Forum 2004;10:7-11.
  2. Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, Gottlieb A, Koo JY, Lebwohl M, Lim HW, Van Voorhees AS, Beutner KR, Bhushan R. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 5. Guidelines of care for the treatment of psoriasis with phototherapy and photochemotherapy. J Am Acad Dermatol. 2010 Jan;62(1):114-35.

Dosing Guidelines for Targeted Therapy

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Initial Dose for Psoriasis

Plaque Thickness Mild Moderate Severe
Induration Score 1 2 3
Fitzpatrick skin type 1-3 (dose in mJ/cm2) 500 500 700
Fitzpatrick skin type 4-6 (dose in mJ/cm2) 400 600 900

Dose for Subsequent Treatments

No Effect No erythema at 12-24 hours and no plaque improvement
Minimal Effect Slight erythema at 12-24 hours but no significant improvement
Good Effect Mild to moderate erythema response 12-24 hours
Considerable Improvement Significant improvement with plaque thinning or reduced scaliness or pigmentation occurred

Typical Dosing Change from Prior Treatment Dose

No Effect Increase dose by 25%
Minimal Effect Increase dose by 15%
Good Effect Maintain dose
Considerable Improvement Maintain dose or reduce dose by 15%
Moderate/severe erythema (with or without blistering) Reduce dose by 25% (treat around blistered area until it heals or crust disappears)

References

  1. XTRAC Treatment Guidelines, 12-95359-01 Rev. A March 2007.
  2. Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, Gottlieb A, Koo JY, Lebwohl M, Lim HW, Van Voorhees AS, Beutner KR, Bhushan R. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 5. Guidelines of care for the treatment of psoriasis with phototherapy and photochemotherapy. J Am Acad Dermatol. 2010 Jan;62(1):114-35.

Dosing of 8-Methoxypsoralen for Oral PUVA

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Patient Weight

Pounds Kilograms Drug Dose (mgs)
< 66 lbs < 30 kg 10 mg
66 – 143 lbs 30 kg – 65 kg 20 mg
144 – 200 lbs 66 kg – 91 kg 30 mg
>200 lbs >91 kg 40 mg

References

  1. Adapted with permission from Zanolli MD, Feldman SR. Phototherapy treatment protocols for psoriasis and other phototherapy responsive dermatoses. 2nd ed. New York: Informa Healthcare; 2004.
  2. Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, Gottlieb A, Koo JY, Lebwohl M, Lim HW, Van Voorhees AS, Beutner KR, Bhushan R. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 5. Guidelines of care for the treatment of psoriasis with phototherapy and photochemotherapy. J Am Acad Dermatol. 2010 Jan;62(1):114-35.

Dosing of UVA Radiation for Oral PUVA

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According to Skin Type

Skin Type Initial Dose (J/cm2) Increments (J/cm2) Max (J/cm2)
Type I 0.5 0.5 8
Type II 1.0 0.5 8
Type III 1.5 1.0 12
Type IV 2.0 1.0 12
Type V 2.5 1.5 20
Type VI 3.0 1.5 20

References

  1. Adapted with permission from Zanolli MD, Feldman SR. Phototherapy treatment protocols for psoriasis and other phototherapy responsive dermatoses. 2nd ed. New York: Informa Healthcare; 2004.
  2. Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, Gottlieb A, Koo JY, Lebwohl M, Lim HW, Van Voorhees AS, Beutner KR, Bhushan R. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 5. Guidelines of care for the treatment of psoriasis with phototherapy and photochemotherapy. J Am Acad Dermatol. 2010 Jan;62(1):114-35.

Psoriasis Treatment Reimbursement Algorithm

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Psoriasis Treatment Reimbursement Algorithm

Psoriasis Treatment Reimbursement Algorithm

CPT Coding for Psoriasis Treatment/Procedures

96910 Photochemotherapy; tar and ultraviolet B (Goeckerman treatment) or petrolatum and ultraviolet B
96912 Photochemotherapy; Psoralens and ultraviolet A (PUVA)
96913 Photochemotherapy (Goeckerman and/or PUVA) for severe photoresponsive dermatoses requiring at least four to eight hours of care under direct supervision of the physician (includes application of medication and dressings)
96920 Laser treatment for inflammatory skin disease (psoriasis); total area less than 250 sq cm
96921 Laser treatment for inflammatory skin disease (psoriasis); total area 250 sq cm to 500 sq cm
96922 Laser treatment for inflammatory skin disease (psoriasis); total area over 500 sq cm
96999 Unlisted special dermatological service or procedure

HCPCS Codes for Psoriasis Treatment

Adalimumab J0135
Alefacept J0215
Etanercept J1438
Golimumab J3590*
Infliximab J1745
Ustekinumab J3357

* To identify this drug to an insurance company, a practice must enter the name of the drug, strength, dose given, and National Drug code (NDC) found on the vial in the information section (item 19) of the CMS1500 claim form.

Psoriasis Treatment Reimbursement Algorithm

The key to effective billing and consistent reimbursement of dermatology services is a thorough understanding of the required coding system and documentation guidelines.

CODING
Health information coding is defined as: "the transformation of verbal descriptions of diseases, injuries, and procedures into numeric or alphanumeric designations."

ICD-9-CM
ICD-9-CM is the tool to use to find the most accurate diagnosis codes that establish medical necessity for the procedures performed in the dermatology practice. Dermatology procedures are coded using CPT codes.

CPT
CPT also includes guidelines and principles for the correct application of CPT procedural codes. Understanding the guidelines for the correct application of CPT as well as knowing how to properly use modifiers, will create a clean claim that bypasses software edits on its first submission, ensuring the claim’s prompt payment.

HCPCS
HCPCS is a system for identifying items and services. It is not a methodology or system for making coverage or payment determinations and the existence of a code does not, of itself, determine coverage or noncoverage for an item or service.

DISCLAIMER
This is a conceptual scheme based on the recommendations of a guideline. A third party payer may have separate or additional requirements. American Academy of Dermatology has provided this information to the best of its knowledge as a guide to providers. AAD does not guarantee reimbursement. Providers assume responsibility for all care provided and claims filed. For additional information please call 866-503-SKIN (7546).

References

Menter A, Gottlieb A, Feldman SR, Van Voorhees AS, Leonardi CL, Gordon KB, Lebwohl M, Koo JY, Elmets CA, Korman NJ, Beutner KR, Bhushan R. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008 May;58(5):826-50.

Psoriatic Arthritis Diagnostic Checklist and Diagnostic/Scoring Criteria

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Compare PsA with
PsA RA OA AS
Peripheral Disease Asymmetric Symmetric Asymmetric No
Sacroiliitis Asymmetric No No Symmetric
Stiffness In AM and/ or with immobility In AM and/or with immobility With activity Yes
Female/Male Ratio 1:1 3:1 Hand/foot more common in females 1:3
Enthesitis Yes No No No
High Titer Rheumatoid Factor No Yes No No
HLA Association CW6, B27 DR4 No B27
Nail Lesions Yes No No No
Psoriasis Yes Uncommon Uncommon Uncommon

Moll and Wright Criteria for Psoriatic Arthritis

* To meet the Moll and Wright 1973 classification criteria for psoriatic arthritis, a patient with psoriasis and inflammatory arthritis who is seronegative for RA must present with 1 of the above 5 clinical subtypes. Moll and Wright specificity is 98% and sensitivity is 91%.

CASPAR Criteria for the Diagnosis of Psoriatic Arthritis

The CASPAR (classification criteria for psoriatic arthritis) criteria consist of established inflammatory articular disease* with at least 3 points from the following features:

  1. Current psoriasis (assigned a score of 2; all other features are assigned a score of 1)
  2. A personal history of psoriasis (unless current psoriasis is present)
  3. A family history of psoriasis (unless current psoriasis is present or there is a personal history of psoriasis)
  4. Current dactylitis or history of dactylitis recorded by a rheumatologist
  5. Juxta-articular new bone formation
  6. Rheumatoid factor negativity
  7. Typical psoriatic nail dystrophy including onycholysis, pitting, and hyperkeratosis

* Prolonged morning or immobility-induced stiffness, tender and swollen joints suggest an inflammatory joint disease.

American College of Rheumatology Scoring

ACR50 and ACR70 analysis include the same criteria as ACR20, with the use of a higher percentage improvement (50% and 70%).

Sharp Scoring

Photographs of Patients with Psoriatic Arthritis

References

Gottlieb A, Korman NJ, Gordon KB, Feldman SR, Lebwohl M, Koo JY, Van Voorhees AS, Elmets CA, Leonardi CL, Beutner KR, Bhushan R, Menter A. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol. 2008 May;58(5):851-64.

Case Studies and Treatment Algorithms

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Treatment Algorithms

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Treatment of Patients with Limited Disease

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Treatment of Patients with Limited Disease

*Note the use of more potent topical corticosteroids must be limited to the short term i.e. <4 weeks, with gradual weaning to 1-2 times a week usage once adequate control is obtained, and the introduction of a secondary agent, e.g. vitamin D3 preparations should be used for long term safe control

Psoriasis w/o Psoriatic Arthritis

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Adults with Palmoplantar Psoriasis, male or female not of childbearing potential

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Adults with Palmoplantar Psoriasis, male or female not of childbearing potential

Algorithm

Erythrodermic Psoriasis, male or female not of childbearing potential

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Erythrodermic Psoriasis, male or female not of childbearing potential

Algorithm

Pediatric Psoriasis (<18 yrs, >5% BSA)

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Pediatric Psoriasis (<18 yrs) with >5% BSA, w/o Psoriatic Arthritis

Algorithm

*Etanercept is the only medication that has level 1 evidence to support this recommendation.

Chronic Plaque Psoriasis (>5% BSA), female trying to conceive

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Women Trying to Conceive with Chronic Plaque Psoriasis (>5% BSA), w/o Psoriatic Arthritis

Algorithm

Chronic Plaque Psoriasis (>5% BSA), healthy adult male

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Healthy Adult Males with Chronic Plaque Psoriasis (>5% BSA), w/o Psoriatic Arthritis

Algorithms

Chronic Plaque Psoriasis (>5% BSA), female of childbearing potential using appropriate contraception

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Women of Childbearing Potential Using Appropriate Contraception with Chronic Plaque Psoriasis (>5% BSA), w/o Psoriatic Arthritis

Algorithm

Psoriasis w Psoriatic Arthritis

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Adults with Psoriasis (>5% BSA), with Concurrent Psoriatic Arthritis

Algorithm

*Mild psoriatic arthritis can be treated with appropriate non-steroidal anti-inflammatory agents. +NSAIDS and low dosage prednisone (<10 mg/day) can be used as adjunctive therapy.

Case Studies

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Limited Disease

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Limited Disease

Patient with limited disease (<5% BSA): There are erythematous, predominantly discoid plaques with overlying silvery scale involving the elbows, knees, periumbilical area and back.

Requiring More Than Topical Therapy

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Ultraviolet B

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Ultraviolet

PUVA Photochemotherapy

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PUVA Photochemotherapy

Palmoplantar Psoriasis

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Palmoplantar Psoriasis

Severe plantar disease: There are erythematous scaling and fissured hyperkeratotic plaques involving the plantar surfaces.

Recalcitrant Psoriasis and Multiple Co-Morbidities

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Recalcitrant Psoriasis and Multiple Co-Morbidities

A woman with generalized psoriasis: There are thick, inflammatory, scaly plaques involving 35% of her BSA

Erythrodermic Psoriasis

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Erythrodermic Psoriasis

Patient with erythrodermic psoriasis: Generalized inflammatory patches and plaques cover 95% of the BSA

References

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References

Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, Gottlieb A, Koo JY, Lebwohl M, Leonardi CL, Lim HW, Van Voorhees AS, Beutner KR, Ryan C, Bhushan R. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011 Jul;65(1):137-74.

Psoriatic Arthritis

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Psoriatic Arthritis

Patient with psoriatic arthritis

Gaps in Research

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Natural History of Disease

  1. There is a need for large prospective longitudinal broadly representative cohort studies of psoriasis.
  2. Environmental risk factors remain poorly defined.1, 2
  3. For identified risk factors (such as smoking, alcohol and obesity) data are necessary to determine if modification of these risk factors will prevent psoriasis or modify its severity.
  4. The prognosis of psoriasis is poorly understood. The rate at which psoriasis will get worse over time vs. spontaneously clear as well as the determinants of alterations in psoriasis activity need to be further elucidated.

Sub-populations

  1. The natural history and morbidity in sub-populations including children, pregnant and lactating women, the elderly, and minorities requires more study.
  2. Little is known about disparities in treatment, health related quality of life, and other factors in sub-populations. 3-5

Co-morbidities

  1. Psoriatic arthritis
    1. The natural history of PsA is poorly defined in the dermatology setting. It is necessary to determine the severity of PsA and the prognosis of PsA of patients who are identified in the dermatology setting.
    2. Data are necessary to determine if better control of psoriasis through more aggressive therapy will lead to a lower incidence of PsA.
  2. Cardiovascular disease
    1. The impact of objective psoriasis severity on CV risk is unknown.6-11
    2. Studies are needed to determine how to optimize prevention of CV events in patients with psoriasis. c. A central question is whether aggressive systemic therapy of psoriasis leads to lower CV risk.12, 13
  3. Obesity and metabolic disease
    1. Data are necessary to determine if achieving an ideal BMI will lower the risk of developing psoriasis and if, among those with psoriasis, if achieving a normal BMI will improve skin and joint disease.
    2. The degree to which obesity explains the higher risk of Diabetes and metabolic syndrome observed in some studies requires additional study. 14
  4. Many co-morbidities have been relatively understudied including psychiatric (anxiety, depression, suicide), osteoporosis, infection, and chronic obstructive pulmonary disease.
  5. Mortality: Studies indicate that patients with severe psoriasis have excess mortality. The causes of death and degree to which these are altered by psoriasis itself, its treatments, or co-morbid behaviors requires further study.

Treatment

  1. The comparative effectiveness of psoriasis treatments for plaque psoriasis is understudied. The few studies which exist are short term.15 Current data make it difficult to determine which drugs are most safe and effective long term for psoriasis and therefore should be considered the preferred treatment for most patients. As a result, most recommendations are broad and list options in “alphabetical” order.
  2. The comparative effective of psoriasis treatments for clinical variants including guttate psoriasis, pustular psoriasis, erythrodermic psoriasis, inverse psoriasis and palmoplantar psoriasis is an area with almost no data.
  3. Most safety data for psoriasis therapies comes from other diseases particularly rheumatoid arthritis (RA). It is unclear if such data acutely reflect the safety of TNF inhibitors, methotrexate, and other therapies in the psoriasis population.
  4. The risks of clinically significant liver toxicity when using existing liver biopsy guidelines to treat psoriasis patients with methotrexate requires further study.
  5. The safety and effectiveness of home or office based NB UVB in comparison to other treatments in the US population requires additional study. Studies indicate that the majority of patients with objectively severe psoriasis are treated only topically or not all. More data are necessary to determine the patient, physician, treatment, and economic factors that result in most patients with severe disease not achieving long term control of their psoriasis.

Genetics and Pathomechanisms

  1. Studies evaluating the correlation between psoriasis genotype and phenotype should be undertaken. 16-18
  2. The vasculature has been understudied. An animal model that over-expresses the angiopoietin receptor in keratinocytes leads to mice bearing numerous criteria of psoriasis. 5, 19

References

  1. Farber EM , Nall ML. The natural history of psoriasis in 5,600 patients. Dermatologica 1974;148:1-18.
  2. Christensen TE, Callis KP, Papenfuss J, Hoffman MS, Hansen CB, Wong B et al. Observations of psoriasis in the absence of therapeutic intervention identifies two unappreciated morphologic variants, thin-plaque and thick-plaque psoriasis, and their associated phenotypes. J Invest Dermatol 2006;126:2397-403.
  3. Ben-David G, Sheiner E, Hallak M , Levy A. Pregnancy outcome in women with psoriasis. J Reprod Med 2008;53:183-7.
  4. Horn EJ, Chambers CD, Menter A , Kimball AB. Pregnancy outcomes in psoriasis: why do we know so little? J Am Acad Dermatol 2009;61:e5-8.
  5. Griffiths CE. Management of psoriasis in pregnancy: time to deliver? Br J Dermatol 2010;163:235.
  6. Gelfand JM, Shin DB, Neimann AL, Wang X, Margolis DJ , Troxel AB. The risk of lymphoma in patients with psoriasis. J Invest Dermatol 2006;126:2194-201.
  7. Neimann AL, Shin DB, Wang X, Margolis DJ, Troxel AB , Gelfand JM. Prevalence of cardiovascular risk factors in patients with psoriasis. J Am Acad Dermatol 2006;55:829-35.
  8. Gelfand JM, Neimann AL, Shin DB, Wang X, Margolis DJ , Troxel AB. Risk of myocardial infarction in patients with psoriasis. JAMA 2006;296:1735-41.
  9. Mallbris L, Granath F, Hamsten A , Stahle M. Psoriasis is associated with lipid abnormalities at the onset of skin disease. J Am Acad Dermatol 2006;54:614-21.
  10. Mallbris L, Akre O, Granath F, Yin L, Lindelof B, Ekbom A et al. Increased risk for cardiovascular mortality in psoriasis inpatients but not in outpatients. Eur J Epidemiol 2004;19:225-30.
  11. Qureshi AA, Choi HK, Setty AR , Curhan GC. Psoriasis and the risk of diabetes and hypertension: a prospective study of US female nurses. Arch Dermatol 2009;145:379-82.
  12. Prodanovich S, Ma F, Taylor JR, Pezon C, Fasihi T , Kirsner RS. Methotrexate reduces incidence of vascular diseases in veterans with psoriasis or rheumatoid arthritis. J Am Acad Dermatol 2005;52:262-7.
  13. Menter A. Antagonizing p40 Cytokines May Promote Paradoxical Cardiovascular Risk in Patients With Psoriasis: report of a meta-analysis and consensus meeting. Manuscript submitted. 2010.
  14. Sommer DM, Jenisch S, Suchan M, Christophers E , Weichenthal M. Increased prevalence of the metabolic syndrome in patients with moderate to severe psoriasis. Arch Dermatol Res 2006;298:321-8.
  15. Griffiths CE, Strober BE, van de Kerkhof P, Ho V, Fidelus-Gort R, Yeilding N et al. Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis. N Engl J Med 2010;362:118-28.
  16. Elder JT, Bruce AT, Gudjonsson JE, Johnston A, Stuart PE, Tejasvi T et al. Molecular dissection of psoriasis: integrating genetics and biology. J Invest Dermatol 2010;130:1213-26.
  17. Griffiths CE. Psoriasis: future research needs and goals for the twenty-first century. Dermatol Clin 2004;22:493-9, x.
  18. Ryan C, Banchereau R, Obermoser G, Lemoine B, Pascual V , Banchereau J. Pharmacogenomics of psoriasis treatment. Manuscript in preparation. 2010.
  19. Wolfram JA, Diaconu D, Hatala DA, Rastegar J, Knutsen DA, Lowther A et al. Keratinocyte but not endothelial cell-specific overexpression of Tie2 leads to the development of psoriasis. Am J Pathol 2009;174:1443-58.
  20. Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, Gottlieb A, Koo JY, Lebwohl M, Leonardi CL, Lim HW, Van Voorhees AS, Beutner KR, Ryan C, Bhushan R. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011 Jul;65(1):137-74.

About

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American Academy of Dermatology

Correspondence: PO Box 4014
Schaumburg, Illinois 60168
Toll-free: 866.503.SKIN (7546)
International: 847.240.1280
Fax: 847.240.1859

Authors

Alan Menter, MD, Neil J Korman, MD, PhD, Craig A. Elmets, MD, Steven R. Feldman, MD, PhD, Joel M. Gelfand, MD, MSCE, Kenneth B. Gordon MD, Alice Gottlieb, MD, PhD, John Y.M. Koo, MD, Mark Lebwohl, MD, Craig L Leonardi, MD, Henry W. Lim, MD, Abby S. Van Voorhees, MD, Karl R. Beutner, MD, PhD, Caitriona Ryan MB, BCh, BAOn and Reva Bhushan, PhD

Copyright © 2011 American Academy of Dermatology. All rights reserved. Artwork by Reva Bhushan and Nicole Torling