Background/Purpose: There is limited evidence on the safety of treatment during pregnancy and lactation. With the increasing number of new therapeutic options for inflammatory rheumatic diseases, there is a growing need for real-life data. Prospective randomized studies are not conducted in women who are pregnant or wish to conceive. The purpose of our register is to determine the safety of various drug treatments during pregnancy and the influence of the underlying rheumatic disease on pregnancy outcome and child development.

Methods: The Rhekiss register is designed as a web-based nationwide cohort study. Pregnant patients with confirmed diagnosis of inflammatory rheumatic disease are enrolled until the 20th week of pregnancy regardless of treatment. Rheumatologists and patients report each trimester during pregnancy and semi-annually after birth until the child’s 2nd birthday. Information on all given drug treatments, the course of the maternal disease, maternal or fetal complications during pregnancy, pregnancy outcomes and child development are collected. At first visit sociodemographic parameters, prior pregnancies, and comorbidities are reported. Only pseudonymized data are used, data security issues conform with regulatory authorities have been implemented.

Results: The register started on 15th of September 2015. Until end of May 2016, 84 rheumatologists recruited 200 pregnant women. We report first data of 182 patients. Of these, 28% had rheumatoid arthritis (RA), 23% systemic lupus erythematosus, 19% other connective tissue diseases, 18% spondyloarthritis or psoriatic arthritis, 6% juvenile idiopathic arthritis (JIA), 4% autoinflammatory diseases and 2% systemic vasculitis. Mean age of all patients was 32.5 (± 4.6) years, mean disease duration 8.3 (± 7.5) years. Mean disease activity over all diagnoses assessed by the rheumatologist on a numeric rating scale from 0-10, was 2.3 (± 2.1). On a disease severity scale ranging from 1 to 5 (highest grade), two thirds of all patients were reported grade 2 or 3. With respect to the different underlying diseases up to 60 % received treatment with biological DMARDs within 12 months before first visit, mainly patients with RA or JIA. One quarter of these patients continued biological DMARDs at least until conception.

Conclusion: The German pregnancy register Rhekiss was initiated to fill the knowledge gap on the course and outcomes of pregnancies in patients with rheumatic diseases as well as on the current use and safety of treatments during pregnancy and lactation. The fast uptake of patients shows that there is a substantial need for and a high interest in real-life data to guide treatment decisions

« Back to 2016 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/first-results-from-the-prospective-german-pregnancy-register/