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Remicade - infliximab is used to treat certain types of arthritis: rheumatoid arthritis, arthritis of the spine, psoriatic arthritis, certain bowel diseases: Crohn's disease, ulcerative colitis and a certain severe skin disease: chronic plaque psoriasis. In these conditions, the body's defense immune system attacks healthy tissues.
Based on the results of animal studies with Remicade, the medicine was classified in a pregnancy category B. Category B means that the medicine does not appear to cause harm to the fetus. Although, the full risks of taking Remicade during pregnancy are not known. If you are taking Remicade and pregnancy occurs, your doctor or pharmacist will weigh the benefits and risks before making a recommendation.
Almost none information exists on the safety of Remicade in human pregnancy, but the medicine is approved for use in Crohn's disease, rheumatoid arthritis, and ankylosing spondylitis, diseases that commonly affect women during their childbearing years. The researchers identified 146 pregnancies. 131 of pregnancies involved women exposed directly to infliximab and 15 of which involved their partners being exposed to infliximab. Outcome data were available for 96 of these women. 85% women received Remicade as a treatment for Crohn's disease, 8% had rheumatoid arthritis, 2% had juvenile RA and 1% had ulcerative colitis.
Just over half - 55% received Remicade within 3 months of conception. A third of those were treated both within 3 months of conception and during the first trimester of pregnancy, 31% first received Remicade during the first trimester, 7% received the TNF inhibitor more than 3 months before conception and in 6% the timing of exposure was unknown.
In conclusion 96 direct exposure pregnancies, 64 of 96 (67%) resulted in live births. Spontaneous miscarriage occurred in 14% and therapeutic termination of pregnancy in 19%. These results were similar to those expected for the general population and were also consistent with other studies of pregnancy in inflammatory bowel disease.
None of the complications during pregnancy can be directly attributed to infliximab, the researchers say, but they caution that follow-up of larger numbers of pregnant women exposed to the TNF inhibitor will be necessary to definitively exclude any fetal risk. In addition to Remicade, many of the patients were taking concomitant medicines.
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