Pregnant women with arthritis who take biologic drugs are being asked to continue or stop their medication in a trial to settle a long-standing clinical dilemma. The MAMA trial will recruit 328 women across 35 UK obstetric units, randomly assigning them to either keep taking their biologic disease-modifying drugs throughout pregnancy or stop before the third trimester and restart after birth. The problem is that doctors and patients have no clear evidence on whether these drugs are safe to continue during pregnancy. Autoimmune inflammatory arthritis affects 1–2% of people, many of them women of reproductive age, and uncontrolled disease activity can damage joints and complicate pregnancy. Yet stopping medication risks a flare that harms both mother and baby. Current practice is inconsistent, driven by fear rather than data. If the trial shows that continuing biologics is safe and effective, it could transform antenatal care for thousands of women with arthritis, allowing them to maintain disease control without unnecessary interruption of treatment. If stopping proves better, it will provide clear guidance for planned medication pauses. Either way, the results will give clinicians and patients evidence-based rules for managing these drugs in pregnancy, and will provide the first robust data on infant immune development after in-utero biologic exposure.
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Research Question In pregnant women with Autoimmune Inflammatory Arthritis (AIA) (population), does continuing biological disease modifying anti-rheumatic drugs (bDMARDs) (intervention), compared with stopping bDMARDs before the third trimester of pregnancy (comparator) result in lower peak inflammatory arthritis disease activity (outcome), during and up to six months post-pregnancy? Background AIAs are devastating, potentially joint destroying conditions, affecting 1-2% of people. AIA includes rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (AxSpA) and juvenile idiopathic arthritis (JIA). These AIA conditions collectively affect many women during their reproductive years, and many women with these chronic conditions wish to plan pregnancy. The Monoclonal Antibody Medications in inflammatory Arthritis (MAMA) trial is designed to address the significant uncertainty surrounding the effects of continuing or stopping bDMARDs during pregnancy. Aims and Objectives Aim: To investigate whether continuing bDMARDs in pregnancy compared to stopping before the third trimester is clinically and cost-effective for women with AIA and their children. Primary objective: To compare the peak of disease activity from trial entry up to 6 months post-pregnancy in pregnant women with AIA randomised to continue bDMARDs versus those randomised to stopping bDMARDs before the third trimester of pregnancy. Secondary objectives: • To investigate the effect of continuing bDMARDs on pregnancy outcomes and neonatal outcomes, and other maternal outcomes measured at 3, 6, and 12 months post-pregnancy. • To investigate infant and child outcomes including infection, immune function at 2, 5 and 13 months, and global development at 24 months of age. • To conduct an economic evaluation. Methods Design: MAMA is a multicentre, pragmatic, two-arm, parallel-group, unblinded randomised controlled trial, with an internal pilot and an integrated health economic analysis, co-designed with lived experience contributors. Intervention: Continuing bDMARDs throughout pregnancy. Comparator: Stopping bDMARDs before the third trimester (28 weeks’ gestation) and restarting no earlier than 2 weeks postpartum. Setting: 35 obstetric units with a maternal medicine service. Population: Pregnant women =28 completed weeks’ gestation prescribed a regularly dosed bDMARD for AIA. Outcomes Primary outcome: Peak disease activity as measured by highest self-reported RAPID3 score post-randomisation up to 6 months post-pregnancy. Secondary outcomes: Disease activity, pregnancy, neonatal and child outcomes, costs, and patient and clinician acceptability. Sample size: 328 women (164 per trial arm) individually randomised. Timeline Trial duration of 72 months: 6 months set up; 48 month recruitment; 12 months follow up, 6 months data collection, analysis, reporting Impact and dissemination This will be the first adequately powered trial to assess the safety and efficacy of the use of bDMARDs in AIA in pregnancy, for women and their children. Regardless of the trial results, MAMA will lead to more evidence-based practice and cost effective care for women with AIA in pregnancy and will provide important data in infant immune responses after in-utero biologic exposure. We will disseminate results through journals, conferences, co-designed materials, social media and free online conferences for patients, families and healthcare professionals.
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