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Safety of Tofacitinib in Pregnancy

June 12 2015 10:00 AM ET via RheumReports RheumReports

A poster caught my eye this morning titled "Pregnancy outcomes in the tofacitinib RA safety database through April 2014." There is growing evidence regarding the safety of anti-TNFs in pregnancy but how about about the new kid on the block? In rat and rabbit models, tofacitinib has been shown to be teratogenic at dosages much higher than the approved human doses. Clinical trials of tofacitinib excluded pregnant patients and patients of childbearing age were required to use effective contraception. Study drug was discontinued if the patient became pregnant.

From Pfizer's internal safety database, 35 pregnancy cases were identified: 32 from trials, 2 from post-approval safety studies and 1 from adverse event reporting. In utero exposure ranged from 7 to 244 days. 17 cases were on tofacitinib monotherapy and 14 were on combo therapy with MTX.

Overall outcomes showed 46% healthy newborns, 6 cases of spontaneous abortion, and 1 pulmonary valve stenosis. Most of the adverse outcomes occurred in the patients on combo therapy with MTX and the spontaneous abortion rate was consistent with published rates in patients on MTX for rheumatic diseases, which is reassuring.

The study has some serious limitations, however, including that it was not a prospective analysis, some of the cases had limited information on the date of conception and gestational age, and no data on male exposure were included. The authors advised that tofacitinib should only be used in pregnancy if the potential benefit justifies the potential risk. Pregnancy outcomes with tofacitinib are continuing to be monitored through routine pharmacovigilance and the OTIS (Organization of Teratolgy Information Specialists) registry.


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About the Author

Dr. Shelly Dunne
Dr. Shelly Dunne

Dr. Shelley Dunne is a graduate of Memorial University of Newfoundland School of Medicine. She completed her training in Internal Medicine and a fellowship in Rheumatology at the University of Toronto. She has been in private practice since 1998 and is currently a consulting rheumatologist at the Toronto East General Hospital.

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