Outcomes of Pregnancies With Maternal/Paternal Exposure in the Tofacitinib Safety Databases for Ulcerative Colitis
Open Access
- 30 November 2018
- journal article
- research article
- Published by Oxford University Press (OUP) in Inflammatory Bowel Diseases
- Vol. 24 (12), 2494-2500
- https://doi.org/10.1093/ibd/izy160
Abstract
Background: Active inflammatory bowel disease increases the risk of adverse pregnancy outcomes. Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). As a small molecule, tofacitinib is likely to cross the placental barrier; however, information on the effects of tofacitinib on pregnancy outcomes is limited. We report pregnancy and newborn outcomes among patients in UC clinical studies with prenatal (maternal/paternal) exposure to tofacitinib. Methods: Pregnancies with maternal/paternal exposure to tofacitinib were identified and outcomes reported in 5 tofacitinib UC interventional studies (up to March 2017). Outcomes from tofacitinib rheumatoid arthritis (RA), psoriasis, and psoriatic arthritis interventional studies, and RA noninterventional postapproval safety studies, spontaneous adverse event reporting, and registry data are also reported. Results: Of 1157 patients enrolled in the UC interventional studies, 301 were women of childbearing age. Eleven cases of maternal exposure and 14 cases of paternal exposure to tofacitinib (doses of 5 mg or 10 mg twice daily) before/at the time of conception or during pregnancy were identified. Outcomes included 15 healthy newborns, no fetal deaths, no neonatal deaths, no congenital malformations, 2 spontaneous abortions, and 2 medical terminations. Outcomes across other tofacitinib studies and postmarketing cases were consistent, with a healthy newborn being the most common outcome and no fetal deaths. Conclusions: Based on the limited data available, pregnancy and newborn outcomes among patients with prenatal (maternal/paternal) exposure to tofacitinib in UC studies appear similar to those reported for other tofacitinib clinical study populations and the general population.Funding Information
- Pfizer Inc.
This publication has 26 references indexed in Scilit:
- Tofacitinib as Induction and Maintenance Therapy for Ulcerative ColitisThe New England Journal of Medicine, 2017
- The Effects of Active IBD During Pregnancy in the Era of Novel IBD TherapiesThe American Journal of Gastroenterology, 2016
- The Toronto Consensus Statements for the Management of Inflammatory Bowel Disease in PregnancyGastroenterology, 2016
- Tofacitinib withdrawal and retreatment in moderate-to-severe chronic plaque psoriasis: a randomized controlled trialBritish Journal of Dermatology, 2014
- Tofacitinib versus Methotrexate in Rheumatoid ArthritisThe New England Journal of Medicine, 2014
- Placental Transfer of Anti–Tumor Necrosis Factor Agents in Pregnant Patients With Inflammatory Bowel DiseaseClinical Gastroenterology and Hepatology, 2013
- Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a randomised phase 3 trialThe Lancet, 2013
- Tofacitinib or Adalimumab versus Placebo in Rheumatoid ArthritisThe New England Journal of Medicine, 2012
- European evidenced-based consensus on reproduction in inflammatory bowel diseaseJournal of Crohn's and Colitis, 2010
- A meta-analysis on the influence of inflammatory bowel disease on pregnancyGut, 2007