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An evidence-based review of skin cancer rates on biologic therapies

Abstract Objective: To critically review the body of clinical trials that report the rates of skin cancer in patients on a biologic therapy, in order to discern whether this therapy is associated with any increase risk of skin cancer. Data Sources: Review of MEDLINE database and the Cochrane library database was conducted, to identify randomized controlled trials and meta-analyses that evaluated the safety of biologic therapies, and specifically reported rates of skin cancer in patients on biologic therapies. Study Selection and Data Extraction: Two reviewers independently evaluated eligibility and collected the data. Studies selected were large randomized controlled trials and meta-analyses with large number of patient populations from clinical trials and post-marketing surveillance data that reported specifically the rate of skin cancer while on a biologic therapy. Data Synthesis: Nine studies met the eligibility criteria. All studies were of high quality with Strength of Recommendation Taxonomy (SORT) (J Am Board Fam Pract 2004) evidence level of 1. Eight of these trials demonstrated an increased risk of non-melanoma skin cancer (NMSC) while on a biologic therapy. In addition, studies suggested a possible increased risk in patients with history of prior treatments known to also increase risk of skin cancer. Case studies with SORT evidence level 3 are also included in this review for completion; however, these data were not used in the formation of final recommendations. Conclusion: Biologic medications are highly efficacious and have a relatively good safety profile; however, high-quality evidence suggests that use of biologic therapies may be associated with an increased risk of detection of NMSC. Psoriatic patients may be at an increased risk due to history of treatment with other therapies also known to increase the risk of skin cancer. As such, it may be important to consider biologic therapies as an additional risk factor for development of NMSC and implement regular skin examinations for patients on these therapies.