Which tests should be ordered before prescribing a biologic?

Acta Eruditorum

Abby Van Voorhees

Dr. Van Voorhees is the physician editor of Dermatology World. She interviews the author of a recent study each month.

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In this month’s Acta Eruditorum column, Physician Editor Abby S. Van Voorhees, MD, talks with William W. Huang, MD, MPH, about his recent Journal of the American Academy of Dermatology article, “To test or not to test? An updated evidence-based assessment of the value of screening and monitoring tests when using systemic biologic agents to treat psoriasis and psoriatic arthritis.”

Dr. Van Voorhees: I am so glad to speak with you about your paper about the screening recommendations for patients on biologic agents. Didn’t the FDA recommend testing that should be performed? How about in the AAD’s guidelines of care?

Dr. Huang: This particular study was an update of a previous study our group had published in 2008 (J Am Acad Dermatol 2008;58:970-7). As the use of biologics in dermatology has increased dramatically in recent years, we wanted to evaluate the evidence for the screening and monitoring tests that are routinely performed for patients with psoriasis and psoriatic arthritis on biologic therapy.

We found that current guidelines for screening and monitoring tests varied amongst various national organizations (Table 1 in our paper) including the American Academy of Dermatology, Japanese Dermatology Association, European Academy of Dermatology and Venereology, and the British Association of Dermatologists. We wanted to evaluate what the current evidence to support these recommendations was.

As dermatologic care providers, we make numerous decisions about our patients based on guidelines, clinical experience, professional judgment, and individual clinical situations.

Dr. Van Voorhees: What did you find? How strong are the recommendations on the need to screen and monitor patients who are on biologic agents?

Dr. Huang: Our group searched the PubMed database for reviews or abstracts of randomized controlled trials pertaining to systemic biologic treatments and screening tests in the context of psoriasis and psoriatic arthritis. All resulting records were then screened (this process is described in Figure 1 of our paper). Using evidence grading based on methods developed by the US Preventative Services Task Force, we found that the evidence was strongest (Grade B) for tuberculosis screening. High-level evidence was in general lacking for other routine screening and monitoring tests except in select populations.

Dr. Van Voorhees: Was there a difference in the strength of the various recommendations? Based on your analysis is screening and monitoring of biologic agents needed?

Dr. Huang: Recommendations took into account the level of evidence and overall potential net benefit to patients (Table 2 of our 2008 paper). For the general population, the evidence was strongest for screening and monitoring for tuberculosis (Grade B). Both the tuberculin skin test (TST) and interferon-gamma release assay (IGRA) are acceptable screening and monitoring methods. In studies comparing the two methods, IGRA was preferred due to higher sensitivities and higher specificities. In addition, IGRA does not require a return visit within 48-72 hours and is not subject to factors related to variations in administration and interpretation.[pagebreak]

Dr. Van Voorhees: How about in the setting of a known concurrent disease — did you find data that supports the need for screening and/or monitoring of benefit in this situation? What was found when you have a suspicion that the patient might be at risk for a concurrent illness such as hepatitis or HIV; should we screen in those situations?

Dr. Huang: Other screening and monitoring tests should be based on the provider’s assessment of a patient’s individual risk. For patients with hepatitis and HIV, treatment and monitoring should be performed in close conjunction with the patient’s infectious disease provider weighing potential risks and benefits. However, I have not formally analyzed the data yet.

Dr. Van Voorhees: What are the practical recommendations from your study?

Dr. Huang: In general, biologics are effective and safe treatment options for patients with psoriasis and psoriatic arthritis who are appropriate candidates for such therapy. Biologics have truly revolutionized the way we are able to treat our patients with psoriasis and psoriatic arthritis. The findings of this study may not necessarily be true for patients on biologics for other medical conditions like inflammatory bowel disease and rheumatoid arthritis. Currently the evidence is strongest for tuberculosis screening for patients with psoriasis and psoriatic arthritis who plan to start a biologic.

Dr. Van Voorhees: Do you feel that there is a gap in our knowledge? Is more information needed?

Dr. Huang: The goal of our study was not necessarily to change what providers are doing currently, but rather evaluate the evidence to support (or not support) screening and monitoring tests. As public and private insurance carriers and other managed care organizations are looking more and more at cost-effective care, additional studies are needed to establish the evidence and need for screening and monitoring tests for other treatments and medical conditions.

Dr. Huang is assistant professor and program director of dermatology at Wake Forest University. His article appeared in the Journal of the American Academy of Dermatology, September 2015 (73(3):420-428). doi: 10.1016/j. jaad.2015.06.004.