LB1581 Sex differences in adverse event reporting during treatment with TNF-alpha inhibitors for psoriasis

TNF- alpha inhibitors, etanercept (E), adalimumab (A), and infliximab (I), include an indication for the treatment of moderate-to-severe psoriasis and have emerged as an important, and widely used class of drugs. Notably, the incidences of adverse events (AEs) occurring during exposure to these biologic agents are rarely stratified by sex in published trials and are not described in the Full Prescribing Information for each drug. To address this, we conducted a review of literature to determine rates of reported AEs by sex for E, A and I in psoriasis-based randomized clinical trials. PubMed was searched for citations dated from inception-November 2017. Inclusion criteria included English language, (E) OR (A) OR (I), randomized controlled trials, psoriasis and AE data. This generated 556 reports: 259 (E), 164 (A), 133 (I), of which 96 met study criteria: 50 (E), 29 (A), 17 (I) . These 96 reports represented 19,942 patients with psoriasis who were treated with E (11,282 patients), A (5726), or I (2934). Of these 96 reports, only one (E) contained data reporting the incidence of AEs by sex, and only an additional two, one E and one I, contained individual AE data points that explicitly referenced a subject’s sex. Despite the recognized need for sex difference data with drug use, especially in reporting AEs, it remains unclear whether the rates of AEs associated with these biological agents are different for men vs. women. Given the well-known sex differences for cancer and cardiovascular disease, advances and improvements in the collection and reporting of sex differences for AEs with TNF-alpha inhibitors in the management of psoriasis clearly warrant further action to ensure that implementation of mechanisms are put in place to accomplish this unmet need.