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ACR: Few Serious Infections Seen in Infants Exposed to non-TNFis, Tofacitinib

Findings observed for offspring of mothers receiving tofacitinib, non-TNFis for inflammatory disease

WEDNESDAY, Nov. 13, 2019 (HealthDay News) — For offspring of mothers with inflammatory disease, those exposed to tofacitinib or non-tumor necrosis factor inhibitor (TNFi) biologics in utero have few serious infections, according to a study presented at the annual meeting of the American College of Rheumatology, held from Nov. 8 to 13 in Atlanta.

Evelyne Vinet, M.D., Ph.D., from McGill University in Montreal, and colleagues compared the risk for serious infection in 16,490 offspring of mothers with rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, or inflammatory bowel diseases and 164,553 children born to unaffected matched mothers. Among offspring whose mothers had inflammatory disease, 105 were exposed to tofacitinib or non-TNFi biologics and 1,611 were exposed to TNFi biologics during pregnancy.

Among children exposed to tofacitinib or non-TNFi biologics, the researchers identified two cases of serious infection (1.9 percent; 95 percent confidence interval [CI], 0.3 to 7.4): one was exposed to tofacitinib and one to abatacept. In offspring of mothers with inflammatory diseases with no TNFi exposure, the percentage of serious infections was 2.1 percent (95 percent CI, 1.9 to 2.3), while for those with TNFi in utero exposure, 2.3 percent (95 percent CI, 1.6 to 3.0) had serious infections. Serious infections occurred in 1.6 percent (95 percent CI, 1.6 to 1.7) of children born to unaffected mothers.

“This is a first step, as we need more data to confirm safety, particularly regarding other pregnancy outcomes,” Vinet said in a statement. “It is imperative that we further study this issue to provide firm evidence to guide treatment decisions prior to conception and throughout pregnancy.”

Several authors disclosed financial ties to pharmaceutical companies, including Pfizer, which manufactures tofacitinib.

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