Original Contribution
The American Journal of Gastroenterology (2004) 99, 2385–2392; doi:10.1111/j.1572-0241.2004.30186.x
Outcome of Pregnancy in Women Receiving Infliximab for the Treatment of Crohn's Disease and Rheumatoid Arthritis
Financial Support: Centocor Inc. sponsored the preparation of this manuscript.
Jeffry A Katz MD1, Christian Antoni MD1, Gregory F Keenan MD1, Deirdre E Smith1, Stephen J Jacobs1 and Gary R Lichtenstein MD1
1Division of Gastroenterology, Case Western Reserve University, Cleveland, Ohio; Department of Medicine III, University of Erlangen, Erlangen, Germany; Centocor Inc., Malvern, Pennsylvania; Gastroenterology Division, University of Pennsylvania, Philadelphia, Pennsylvania; Division of Gastroenterology, Western Reserve University School of Medicine, University Hospitals of Cleveland, Cleveland, Ohio
Correspondence: Jeffry A Katz, MD, Associate Professor of Medicine, Division of Gastroenterology, Case Western Reserve University School of Medicine, University Hospitals of Cleveland, 11100 Euclid Avenue, Cleveland, OH 44106-5066
Received 23 June 2004; Revised 0000; Accepted 29 June 2004.
Abstract
OBJECTIVES:
Infliximab is approved for the treatment of rheumatoid arthritis (RA) and Crohn's disease (CD). We report the first large series of pregnancy outcomes in women with RA and CD exposed to infliximab.
METHODS:
The infliximab safety database was queried for all reports of pregnancy. Data were extracted regarding the indication for infliximab, timing of infliximab relative to conception, pregnancy course, and pregnancy outcome. The proportion of live births, miscarriages, and therapeutic terminations for women directly exposed to infliximab before or during confirmed pregnancy were compared to those expected for the general U.S. population of pregnant women and pregnant women with CD not exposed to infliximab.
RESULTS:
Of the 146 identified pregnancies, 131 involved women exposed directly to infliximab and outcome data were available for 96 of these women. Live births occurred in 67% (64/96), miscarriages in 15% (14/96), and therapeutic termination in 19% (18/96) of the pregnancies directly exposed to infliximab with available outcome data. These results are similar to those expected for the general U.S. population of pregnant women or pregnant women with CD not exposed to infliximab.
CONCLUSION:
Data from the infliximab safety database suggest that infliximab exposure during pregnancy results in outcomes that do not differ from those in the U.S. population of pregnant women and pregnant women with CD not exposed to infliximab. No increased risk of adverse outcome was detected, however, follow-up of larger numbers of pregnant women exposed to infliximab will be necessary to definitively exclude any fetal risk.
