NEW YORK (Reuters Health)—Patients treated with biologic therapy for rheumatoid arthritis, inflammatory bowel disease and psoriasis don’t appear to be at increased risk of melanoma, according to the results of a systematic review and meta-analysis.
However, because the study found trends toward increased melanoma rates with long-term therapy, “a clinically meaningful increase in risk cannot be ruled out,” Shamarke Esse of the University of Manchester, U.K., tells Reuters Health by email.
“Our study is of relevance to dermatologists, rheumatologists and gastroenterologists considering biologic therapy for patients currently on conventional systemic therapy, and researchers interested in the topic,” he says.
Mr. Esse and colleagues searched the literature from 1995–2019 for randomized clinical trials, cohort studies and nested case-control studies quantifying the melanoma risk.
As reported in JAMA Dermatology, seven studies (out of 64 screened for eligibility) were included, involving more than 34,000 patients who received biologics for at least a year and more than 135,000 who were not treated with these drugs.1
Biologic treatment was positively associated with melanoma in patients with inflammatory bowel disease (pooled relative risk, 1.20), rheumatoid arthritis (pRR, 1.20), and psoriasis (hazard ratio, 1.57) compared with those who received conventional systemic therapy; however, the differences were not statistically significant.
Further, most studies did not adjust for other risk factors.
“Population-based cohort studies, adjusting for key risk factors, are urgently required to clarify this risk,” Mr. Esse says. Using data from the British Association of Dermatologists Biologics and Immunomodulators Register, his team will be comparing cancer-related outcomes with biologic vs. non-biologic systemic therapies for psoriasis.2
Dr. Stuart Kaplan, chief of Rheumatology at Mount Sinai South Nassau, Oceanside, N.Y., comments in an email to Reuters Health, “This is a very important issue because many patients are convinced that biologic therapies greatly increase the risk of malignancy, including melanoma.”
“As a result,” he says, “I have seen patients refuse treatments that could prevent them from suffering irreversible joint damage from inflammatory arthritis because of a preconceived fear of a possible disease association for which the available data is unconvincing and even conflicting.”
The study “helps to allay some of the anxiety associated with the use of biologics by failing to find a statistically significant association between biologic exposure and development of melanoma,” he says. “Nonetheless, long-term prospective studies are needed to resolve this issue.”
“This should serve to remind us, as clinicians, to remain vigilant in performing regular surveillance of the skin of our patients with autoimmune diseases in order to facilitate the early detection and treatment of melanoma that is responsible for the deaths of over 9,000 individuals in the U.S. every year.”
References
- Esse S, Mason KJ, Green AC, et al. Melanoma risk in patients treated with biologic therapy for common inflammatory diseases: A systematic review and meta-analysis. JAMA Dermatol. 2020 May 20;e201300.
- Burden AD, Warren RB, McElhone K, et al. The British Association of Dermatologists’ Biologic Interventions Register (BADBIR): Design, methodology and objectives. Br J Dermatol. 2012 Mar;166(3):545–554.
