Pregnancy outcomes of non-tumour necrosis factor inhibitor biologic disease-modifying antirheumatic drugs among individuals with autoimmune diseases: a scoping review and proposed framework for reporting outcomes.

Objectives: Biologic disease-modifying antirheumatic drugs (bDMARDs) have transformed autoimmune disease treatment. Although the perinatal impacts of tumour necrosis factor inhibitors (TNFis) have been systematically synthesised, comparable evidence syntheses for non-TNFi bDMARDs are lacking. We conducted a scoping review to synthesise evidence on the impact of non-TNFi bDMARDs on pregnancy outcomes. Methods: We searched Embase, MEDLINE, and CENTRAL databases in November 2023. We included studies among individuals with chronic autoimmune disease that examined non-TNFi bDMARD exposure in mothers during pregnancy, fathers prior to conception, and/or foetuses/neonates in utero. We extracted data on sample size, study design, drug exposure (dose and duration), pregnancy outcomes, and synthesised patterns in methodologic reporting. Results: Of 6712 studies screened, 135 were included (38 case reports, 25 case series, 40 cross-sectional, and 32 analytical) among patients with inflammatory bowel disease, psoriasis, and rheumatoid arthritis. Ustekinumab, vedolizumab, and tocilizumab were the most studied drugs. The analytical studies assessed 41 pregnancy outcomes, showing significant associations between non-TNFis and preterm birth, congenital anomalies, and miscarriage. For methodologic gaps, we identified substantial heterogeneity across reporting of sample size units, drug exposure (timing and duration), and pregnancy outcomes. In response, we developed a Reproductive Health Outcomes Reporting Framework to standardise reporting according to maternal, foetal/neonatal, and foetal/neonatal-maternal outcomes. Conclusions: Our scoping review shows that the evidence base for the perinatal impacts of non-TNFi DMARDs is growing. Analytic findings identified evidence gaps that limit informed decision-making for patients and providers around pregnancy. Methodologic findings informed our recommendations for improving reporting practices, thereby enhance the comparability and interpretability of results in future perinatal pharmacoepidemiologic research.