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Pregnancy Outcomes in the Tofacitinib Safety Databases for Rheumatoid Arthritis and Psoriasis.
- Source :
- Drug Safety; Aug2016, Vol. 39 Issue 8, p755-762, 8p
- Publication Year :
- 2016
-
Abstract
- <bold>Introduction: </bold>Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA), and is being investigated for the treatment of psoriasis. Both conditions can present in women of child-bearing potential, but pregnancy was an exclusion and discontinuation criterion in tofacitinib randomized controlled trials (RCTs) because of the unknown effects of tofacitinib on mother and child. Tofacitinib is a small molecule that has the potential to cross the placenta.<bold>Objective: </bold>The objective was to report outcomes of pregnancy cases identified through April 2014 from tofacitinib RA/psoriasis RCTs, RA post-approval non-interventional studies, and spontaneous adverse-event reporting.<bold>Methods: </bold>Pregnancy outcomes were categorized as follows: healthy newborn, medical termination, fetal death, congenital malformation, spontaneous abortion, or pending/lost to follow-up.<bold>Results: </bold>Out of 9815 patients, 1821 female patients of child-bearing age were enrolled in the RA/psoriasis RCTs; 47 women became pregnant, including 33 who received tofacitinib monotherapy, 13 who received combination therapy with methotrexate (RA patients only), and one patient whose therapy was still blinded. No fetal deaths were reported. One congenital pulmonary valve stenosis (monotherapy, n = 1), seven spontaneous abortions (monotherapy, n = 4; combination therapy, n = 3), and eight medical terminations (monotherapy, n = 4; combination therapy, n = 3; blinded therapy, n = 1) were identified. Remaining cases reported healthy newborns (n = 25) or were pending/lost to follow-up (n = 6). Forty-four cases of paternal exposure to tofacitinib were reported (monotherapy, n = 43; combination therapy, n = 1), including five spontaneous abortions (monotherapy, n = 4; combination therapy, n = 1), 23 healthy newborns, and 16 pending/lost to follow-up.<bold>Conclusions: </bold>The pregnancy outcomes reported in this small number of RA/psoriasis patients appear similar to those observed in the general population and in patients treated with biologic therapies for inflammatory diseases. However, definitive conclusions cannot be drawn, and pregnancy outcomes in patients receiving tofacitinib will continue to be monitored. [ABSTRACT FROM AUTHOR]
- Subjects :
- MEDICATION safety
PRENATAL care
RHEUMATOID arthritis
DATABASE design
INFLAMMATION
ANTIRHEUMATIC agents
COMBINATION drug therapy
COMPARATIVE studies
DATABASES
HETEROCYCLIC compounds
LONGITUDINAL method
RESEARCH methodology
EVALUATION of medical care
MEDICAL cooperation
METHOTREXATE
PIPERIDINE
PREGNANCY
PSORIASIS
RESEARCH
EVALUATION research
PROTEIN kinase inhibitors
DISEASE complications
Subjects
Details
- Language :
- English
- ISSN :
- 01145916
- Volume :
- 39
- Issue :
- 8
- Database :
- Complementary Index
- Journal :
- Drug Safety
- Publication Type :
- Academic Journal
- Accession number :
- 117355194
- Full Text :
- https://doi.org/10.1007/s40264-016-0431-z