Background/Purpose: The assumption of spontaneous remission among pregnant women with rheumatoid arthritis (RA) is common. Nevertheless, prospectively collected data describing the course of disease activity during pregnancies in women with long-standing severe RA are rare. Further, observational data suggest that biologic disease modifying anti-rheumatic drugs (bDMARDs) can be safely used until conception but the impact of bDMARD treatment during pregnancy is unclear. We aimed to study pregnancy outcomes and courses of disease activity in women with bDMARD use prior to conception.

Methods: We investigated all pregnancies and their outcomes that were reported to the German biologics register RABBIT until end of 2014. Pregnancies were stratified by treatment in A) biologic-naive, B) bDMARD stopped before or C) bDMARD exposed at time of conception. In a subgroup of patients with pregnancies reported until 2011, additional interviews with a focus on the course of disease activity and treatment during pregnancy were conducted. Descriptive statistics were applied to study associations of pregnancy outcomes, disease activity and treatment.

Results:

In 1,981 female RA patients ≤ 45 years, 106 pregnancies in 88 patients were reported. At time of conception 57 pregnancies were exposed to bDMARDs (C) (29x etanercept, 11x adalimumab, 5x tocilizumab, 4x certolizumab pegol, 3x rituximab, 3x abatacept, 1x infliximab, and 1x golimumab), 11 were biologic naive (A) and 38 had received their last bDMARD infusion or injection at least 4 weeks (rituximab 6 months) before conception (B) (12x etanercept, 9x adalimumab, 2x tocilizumab, 2x infliximab, 13x rituximab). Only 43% of the women being in remission prior to pregnancy remained in remission. From 49 women not in remission prior to conception only 7 (14%) reached remission during pregnancy. In all pregnancies of group C bDMARD treatment was stopped after awareness of pregnancy. In 13 of those (23%) bDMARDs had to be re-started during pregnancy due to high disease activity. No adverse influence of this treatment decision on the childs’ health or pregnancy course was observed.  

The rates of spontaneous abortions were not significantly different between treatment regimens (A: 0, B:13%, C:19%) and in range of general population rates. Induced abortions were reported in 4 out of 106 pregnancies (one due to trisomia 21 with cardiac defect in a 38 year old woman).

Among all live births one major malformation (anal atresia) was detected in a child born to a mother exposed to bDMARDs until 4 weeks prior to conception (group B). Ten premature births occurred: one in a biologic naive woman, and 4 in groups B and C, respectively. In those women disease activity during pregnancy was considerably higher compared to women with mature children.

Conclusion: Within our cohort observing women with long-standing severe RA, we could not confirm the assumption of spontaneous remission during pregnancy. A considerable proportion of women experienced ongoing or worsening disease activity or flares during pregnancy. We confirmed previous reports and found no increased risk of major malformations or other harmful consequences in patients exposed to bDMARDs at time of conception.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/pregnancies-in-patients-with-long-standing-rheumatoid-arthritis-and-biologic-dmard-treatment-course-of-disease-during-pregnancy-and-pregnancy-outcomes/