Few Serious Infections in Offspring Exposed to Non-TNFi Biologics, Tofacitinib

Researchers compared the risk for serious infections in offspring of mothers with chronic inflammatory diseases who received non-TNFi biologics or tofacitinib during pregnancy vs offspring who were unexposed, but exposed to TNFi in utero.

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ATLANTA — Offspring who were exposed to non-TNFi biologics or tofacitinib in utero may not be at increased risk of developing serious infections, according to research results presented at the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, held November 8 to 13, 2019, in Atlanta, Georgia.

Researchers assessed the data of women with ≥1 hospitalization for delivery after a diagnosis of rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriasis, psoriatic arthritis (PsA), or inflammatory bowel disease (IBD), and a group of unaffected mothers matched for age, year of delivery, and state of residence, using the MarketScan database from 2011 to 2016. Eligible patients included women who were continuously enrolled in the database ≥12 months prior to delivery and with available child linkage.

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Researchers defined tofacitinib, TNFi and non-TNFi biologic exposure based on ≥1 filled prescription and/or infusion procedure code during pregnancy and/or the preconception period. Serious infections in the offspring were defined based on ≥1 hospitalization with infection as a primary diagnosis in the first year of life.

Results indicated 16,490 offspring of mothers with RA (n=4142), AS (n=381), psoriasis/PsA (n=5743), and IBD (n=6731), as well as 164,553 children born to unaffected mothers. Of the offspring whose mothers had inflammatory diseases, 105 were exposed to tofacitinib or non-TNFi biologics and 1611 to TNFis during pregnancy. A total of 2 cases of serious infections were found in offspring exposed to tofacitinib or non-TNFi biologics (1.9%, 95% CI, 0.3%-7.4%): 1 was exposed to tofacitinib and the other to abatacept.

The percentage of serious infections in offspring of mothers with inflammatory disease with no TNFi exposure was 2.1%, while for those with TNFi in utero exposure was 2.3%. In offspring of unaffected mothers, the percentage of serious infections was 1.6%.

“In the largest cohort of inflammatory disease offspring ever assembled, we detected very few serious infections in children exposed to non-TNFi biologics or tofacitinib,” the investigators concluded.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

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Vinet E, St-Pierre Y, Moura CS, Curtis J, Bernatsky S. Serious infections in offspring exposed in utero to non-TNFi biologics and tofacitinib. Presented at: 2019 ACR/ARP Annual Meeting; November 8-13, 2019; Atlanta, GA. Abstract 1901.