Abstract

Introduction The increased availability and awareness of biologics safety has led to an increase in their use over the past decade. Previous concern regarding adverse pregnancy outcome resulted in the discontinuation of biologics before carefully planned conception. With the greater appreciation of the safety of a number of these agents, in addition to the need to control the underlying disease activity, many physicians now maintain patients on treatment for at least a portion of their pregnancy. However, conflicting opinions remain and there is little data to the safety of certain biologics in pregnancy. There are multiple systematic reviews that have studied foetal/infant outcomes but not maternal outcomes. Objectives Primarily; to study the effect of biologics during pregnancy on the rate of miscarriage. Secondary outcomes include the rate of maternal infections, C-sections and hypertensive disorders in pregnancy. Methods We performed a comprehensive search to identify potentially relevant published studies on the use of biologics 3-months before or during pregnancy and their effect on maternal outcomes from 1998 to December 2017 in all languages. Databases including PubMed, EMBASE and Cochrane were searched using a detailed strategy. We potentially selected studies and retrieved their full-text. We performed data extraction and currently in the process of quality and risk of bias appraisal and heterogeneity assessment. Incidence data will be combined where feasible in a meta-analysis using Stata software and fixed-effects or random-effects models as appropriate. This systematic review will be reported according to the PRISMA guidelines. Results The search resulted in 1244 studies. 16 studies included (11 TNF-inhibitors, 3 tocilizumab, 1 tofacitinib and 1 abatacept) for the qualitative analysis after excluding other studies from title and abstract and after removing duplicates. We are currently in the process of quality assessment and risk of bias appraisal. In the symposium we will present the final results.

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