Pregnancy outcomes following exposure to abatacept during pregnancy

https://doi.org/10.1016/j.semarthrit.2015.06.016Get rights and content
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Abstract

Objective

To characterize pregnancy outcomes following maternal and paternal exposure to abatacept, using clinical trial and post-marketing data available to the manufacturer.

Methods

All confirmed cases of pregnancy with outcome data reported to the manufacturer up to September 1, 2014 were included. Sources included clinical trials, spontaneously reported (unsolicited) post-marketing cases, and the Organization of Teratology Information Specialists registry. Details recorded included number of live births, spontaneous abortions and terminations, pregnancy complications, and congenital anomalies.

Results

A total of 161 pregnancies with known outcomes were identified between 1995 and September 2014: 151 were following maternal exposure to abatacept and 10 were following paternal exposure. Seven of 86 (8.1%) live births following maternal exposure had congenital anomalies (cleft lip/cleft palate, congenital aortic anomaly, meningocele, pyloric stenosis, skull malformation, ventricular septal defect/congenital arterial malformation, and Down׳s syndrome with premature rupture of membranes at 17 weeks that resulted in a live birth via cesarean section and subsequent infant death). In addition, 59 of the 151 (39.0%) cases with maternal exposure resulted in abortions (40 spontaneous and 19 elective). Of the 10 pregnancies with paternal exposure, there were nine live births and one elective abortion, with no congenital abnormalities identified and no fetal deaths.

Conclusions

Based on these data, there does not appear to be a pattern of congenital anomalies following maternal or paternal exposure to abatacept. No cases of vertebral defects, anal atresia, cardiac defects, tracheo-esophageal fistula, renal anomalies, or limb abnormalities (VACTERL) were noted. Spontaneous abortion rates were within expected range. Abatacept should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

Keywords

Pregnancy
Abatacept
Exposure
Congenital anomalies
Biological disease-modifying antirheumatic drugs

Abbreviations

DMARD
disease-modifying antirheumatic drug
FDA
Food and Drug Administration
MADCF
Metropolitan Atlanta Congenital Defects Program
MMF
mycophenolate mofetil
MMS
mycophenolate sodium
MTX
methotrexate
OTIS
Organization of Teratology Information Specialists
RA
rheumatoid arthritis
RCT
randomized controlled trial
TNF
tumor necrosis factor

Cited by (0)

This study was sponsored by Bristol-Myers Squibb.

Competing interests: Laura Ray, Sudha Vemuri, and Teresa A. Simon are employees and stockholders of Bristol-Myers Squibb. Monica Kumar is a former employee and stockholder of Bristol-Myers Squibb and currently an employee of Sanofi US.

1

Present address: Sanofi US, Bridgewater, NJ.