Pregnancy Outcomes in the Tofacitinib Safety Databases for Rheumatoid Arthritis and Psoriasis

Megan E. B. Clowse, Steven R. Feldman, John D. Isaacs, Alexandra B. Kimball, Vibeke Strand, Richard B. Warren, Daniel Xibillé, Yan Chen, Donald Frazier, Jamie Geier, James Proulx and Amy Marren ()
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Megan E. B. Clowse: Duke University School of Medicine
Steven R. Feldman: Wake Forest University School of Medicine
John D. Isaacs: Newcastle University and Newcastle upon Tyne Hospitals NHS Foundation Trust
Alexandra B. Kimball: Massachusetts General Hospital and Harvard Medical School
Vibeke Strand: Stanford University School of Medicine
Richard B. Warren: University of Manchester, Manchester Academic Health Science Centre
Daniel Xibillé: Hospital General de Cuernavaca
Yan Chen: Pfizer Inc
Donald Frazier: Pfizer Inc
Jamie Geier: Pfizer Inc
James Proulx: Pfizer Inc
Amy Marren: Pfizer Inc

Drug Safety, 2016, vol. 39, issue 8, No 6, 755-762

Abstract: Abstract Introduction 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. Objective 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. Methods Pregnancy outcomes were categorized as follows: healthy newborn, medical termination, fetal death, congenital malformation, spontaneous abortion, or pending/lost to follow-up. Results 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. Conclusions 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.

Date: 2016
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DOI: 10.1007/s40264-016-0431-z

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