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Original Investigation
May 20, 2020

Melanoma Risk in Patients Treated With Biologic Therapy for Common Inflammatory Diseases: A Systematic Review and Meta-analysis

Author Affiliations
  • 1Division of Musculoskeletal and Dermatological Sciences, University of Manchester, Manchester, United Kingdom
  • 2Dermatology Centre, Manchester Academic Health Science Centre, NIHR Manchester Biomedical Research Centre, Salford Royal NHS Foundation Trust, University of Manchester, Manchester, United Kingdom
  • 3QIMR Berghofer Medical Research Institute, Brisbane, New South Wales, Australia
  • 4Cancer Research UK Manchester Institute, Faculty of Biology, Medicine and Health, University of Manchester, United Kingdom
JAMA Dermatol. 2020;156(7):787-794. doi:10.1001/jamadermatol.2020.1300
Key Points

Question  Are patients with inflammatory bowel disease, rheumatoid arthritis, and psoriasis who are treated with biologic therapies at a higher risk of melanoma compared with those treated with conventional systemic therapy?

Findings  In this systematic review and meta-analysis of 7 cohort studies comprising 34 029 biologic-treated and 135 370 biologic-naive, systemically treated patients, biologic-treated patients with inflammatory bowel disease, rheumatoid arthritis, and psoriasis had an increased risk of melanoma compared with those who received conventional systemic therapy, but the difference was not statistically significant.

Meaning  The findings suggest that a clinically meaningful increase in melanoma risk cannot be ruled out; further studies adjusting for key risk factors are required.

Abstract

Importance  Biologic therapies are widely prescribed immunomodulatory agents. There are concerns that compared with treatment with conventional systemic therapy, long-term biologic treatment for common immune-mediated inflammatory diseases, namely inflammatory bowel disease (IBD), rheumatoid arthritis (RA), and psoriasis, may be associated with increased risk of melanoma.

Objective  To examine whether biologic treatment of IBD, RA, or psoriasis is associated with an increased risk of melanoma compared with conventional systemic therapy.

Data Sources  Embase, MEDLINE, and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched for articles published from January 1, 1995, to February 7, 2019, for eligible studies.

Study Selection  Randomized clinical trials, cohort studies, and nested case-control studies quantifying the risk of melanoma in biologic-treated patients with IBD, RA, and psoriasis compared with patients treated with conventional systemic therapy were included.

Data Extraction and Synthesis  Two reviewers independently extracted key study characteristics and outcomes. Study-specific risk estimates were pooled, and random- and fixed-effects model meta-analyses were conducted. Heterogeneity was assessed using the I2 statistic. The Meta-analysis of Observational Studies in Epidemiology (MOOSE) reporting guidelines were followed.

Main Outcomes and Measures  The pooled relative risk (pRR) of melanoma in biologic-treated patients with IBD, RA, and psoriasis compared with biologic-naive patients treated with conventional systemic therapy.

Results  Seven cohort studies comprising 34 029 biologic-treated patients and 135 370 biologic-naive patients treated with conventional systemic therapy were eligible for inclusion. Biologic treatment was positively associated with melanoma in patients with IBD (pRR, 1.20; 95% CI, 0.60-2.40), RA (pRR, 1.20; 95% CI, 0.83-1.74), or psoriasis (hazard ratio, 1.57; 95% CI, 0.61-4.09) compared with those who received conventional systemic therapy, but the differences were not statistically significant. Adjustment for other risk factors was absent from most studies.

Conclusions and Relevance  The findings suggest that clinically important increases in melanoma risk in patients treated with biologic therapy for common inflammatory diseases cannot be ruled out based on current evidence. However, further studies with large patient numbers that adjust for key risk factors are needed to resolve the issue of long-term safety of biologic therapy.

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