As science continues to explore the role of biologics as a therapeutic modality, the currently available options are being utilized more and more as therapies for a variety of dermatologic diseases. At the 2021 Winter Clinical Dermatology Conference, Erin Boh, MD, PhD, held an in-depth discussion of the numerous off-label applications of biologics.
In an interview with The Dermatologist, Dr Boh highlighted some important insights into the off-label use of biologics.
Dr Boh is the Joseph Chastain Clinical Professor of Dermatology and chair of the department of dermatology at Tulane University School of Medicine in New Orleans, LA.
A number of biologics are approved for moderate to severe plaque psoriasis, but what evidence supports their “off-label” use in other psoriasis variants?
There are published data on the use of biologics in other psoriasis subsets—some prospective and some retrospective1-4–and these agents may prove very effective for treating the variants of psoriasis. The real issue is that these drugs are FDA approved for classic or plaque stage psoriasis only, therefore insurance carriers do not have to cover the drug and the cost becomes prohibitive to patients. Thus, access is critical issue. Even pharmaceutical companies are sometimes reluctant to give a drug for off-label use, further adding to limited access.
What is the most important piece of information dermatologists should keep in mind when using an off-label biologic for treatment of diseases such as sarcoidosis?
Since sarcoidosis is granulomatous, I have seen better responses with the TNF monoclonal antibodies in general, so that is the first choice for me.
In this podcast episode, Dr Boh shares the latest updates in safety data for a number of psoriasis therapies, including TNF inhibitors. Listen here
How can dermatologists help patients navigate the high costs associated with off-label biologics?
As dermatologists, we need to fight for coverage. Good documentation and sound science can often convince insurance carriers to cover these drugs, especially when you document that there are no FDA-approved drugs for a particular disease—that means everything is off-label!
Is there anything else we should know regarding the off-label use of biologics?
These therapies afford significant improvement for patients with diseases that often have no adequate treatments, but there are few studies to rely on since many of these diseases are very uncommon or considered orphan diseases. So, I suggest dermatologists understand the pathophysiology or defects of the disease to help make a reasonable choice for treatment, then fight for the drug to be covered for the patient!
References
1. Brummer GC, Hawkes JE, Duffin KC. Ustekinumab-induced remission of recalcitrant guttate psoriasis: a case series. JAAD Case Rep. 2017;3(5):432-435. doi:10.1016/j.jdcr.2017.06.015
2. Carrasquillo OT, Pabón-Cartagena G, Falto-Aizpurua LA, et al. Treatment of erythrodermic psoriasis with biologics: a systematic review. J Am Acad Dermatol. 2020;83(1):151-158. doi:10.1016/j.jaad.2020.03.073
3. Gooderham MJ, Van Voorhees AS, Lebwohl MG. An updated on generalized pustular psoriasis. Expert Rev Clin Immunol. 2019;15(9):907-919. doi:10.1080/1744666X.2019.1648209
4. Ryan C, Menter A, Guenther L, et al. Efficacy and safety of ixekizumab in a randomized, double-blinded, placebo-controlled phase IIIb study of patients with moderate-to-severe genital psoriasis. Br J Dermatol. 2018;179(4):844-852. doi:10.1111/bjd.16736
