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Background There are several known factors influencing the efficacy and tolerability of biological therapies. Whether patient sex affects this is currently unclear, yet this knowledge would be helpful for risk and benefit stratification. This study assesses the role of patient sex on the efficacy and tolerability of biological therapies used for the treatment of IBD. Methods A systematic literature search was performed on 08 April 2019 using Embase (including Medline), Medline OvidSP, Cochrane Central Register of Controlled Trials, Web of Science and Pubmed. The primary outcome was the influence of patient sex on endoscopic outcomes in IBD patients treated with biologicals. The secondary outcome was the influence of patient sex on adverse events during biological therapy. Studies examining either of the outcomes were included in the assessment, regardless of study type or setting. Results The search yielded 19461 citations. After review 55 studies were included in the study, involving 28465 patients treated with adalimumab, certolizumab pegol, infliximab or vedolizumab. Of the 41 studies that objectively examined patient sex and efficacy of biological therapy, none found a significant association. Of the 14 studies examining patient sex and adverse events, 7 found that adverse events such as infections or skin lesions occur more frequently in female than in male patients. No meta-analysis of the primary or secondary outcome could be performed due to lack of exact reporting of summary measures. Conclusion There is no evidence for a sex difference in endoscopically measured response to biological therapies in IBD patients. However, there is a possible influence of sex on the occurrence of adverse events with a higher incidence in females.

journal of crohn's and colitis

P287 Patient sex does not affect endoscopic outcomes of biologicals in patients with inflammatory bowel disease, but is possibly associated with adverse events: A systematic review