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No added risks observed in limited sample with use of biologics during pregnancy
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In a limited study of pregnant women with rheumatoid arthritis, no increased risk of malformations, deaths or other complications were observed in pregnancy outcomes following the use of biological therapies at the time of conception, according to data presented at the European League Against Rheumatism Annual European Congress of Rheumatology.
Researchers collected data from 1,715 patients with rheumatoid arthritis (RA) enrolled in the German RABBIT biologic drug register and identified 95 pregnancies in 78 women. Biologic disease-modifying anti-rheumatic drugs (bDMARDs) were administered at the time of conception in 51 pregnancies between 2001 and 2011. bDMARDs used included Enbrel (etanercept, Amgen) in 26 pregnancies, Humira (adalimumab, AbbVie) in 10 pregnancies, Actemra (tocilizumab, Genentech) in four pregnancis, Cimzia (certolizumab pegol, UCB) in four pregnancies, Rituxan (rituximab, Genentech) in three pregnancies and other biologic drugs in the remaining four patients.
Forty-four women were not exposed to bDMARDs at the time of conception, nine of whom were biologic naïve and 35 of whom had received their last injection or infusion 4 or more weeks prior.
In all treatment regimens, and when compared with the general population, the rates of spontaneous abortion were similar, with induced abortions occurring in four out of the 95 pregnancies.
Following conception, bDMARDs and/or 10 mg or more of glucocorticoids were continued in more than one-third of patients who had been exposed to bDMARDs at the time of conception, according to the researchers.
Spontaneous abortions occurred in 35 patients who discontinued biologics before pregnancy, and one anal atresia with urogenital malformation, one congenital nystagmus and one trisomia 21 with cardiac defect were present. In the 51 patients who received bDMARDs at conception, one talipes was observed and was also present in the mother. Of the nine patients who continued bDMARDs, all pregnancies delivered mature birth compared with seven of nine who were bDMARD naïve. – by Shirley Pulawski
Reference:
Strangfeld A, et al. Paper #OP0017. Presented at: European League Against Rheumatism Annual European Congress of Rheumatology; June 10-13, 2015; Rome.
Disclosure: The researchers report no relevant financial disclosures.