SAN DIEGO—During ACR Convergence on Nov. 12, Anna Molto, MD, PhD, HDR, rheumatologist and researcher at Cochin Hospital, Paris, presented a study on the real-life pregnancy outcomes of women who were treated with tumor necrosis factor inhibitors (TNFi’s).1
The observational study used data from Système National des Données de Santé, a nationwide French health insurance database. More than 2,000 pregnant women with chronic rheumatic inflammatory diseases treated with TNFi’s between 2008 and 2017 were evaluated. The frequency of unfavorable pregnancy outcomes, including malformations, obstetrical complications and infections, were compared between the treatment strategies at diagnosis of pregnancy. Inverse probability weighted marginal models were used.
The study evaluated a total of 2,082 women with singleton pregnancies. The mean age of these women at the start of pregnancy was 31 years (±5 years standard deviation [SD]), and the mean duration of chronic rheumatic inflammatory disease was four years (± 5 years SD). Of these, 578 had rheumatoid arthritis (RA) and 1,503 had spondyloarthritis (SpA) and had been exposed to TNFi’s for six weeks after their last menstrual period. In total, 1,497 (72%) of women evaluated discontinued TNFi treatment during their pregnancy.
The study found that continuing TNFi therapy was not associated with an increase in the frequency of unfavorable obstetrical or infant outcomes. For the study group that continued TNFi’s, the proportion of women with severe infections (i.e., those who required hospitalization) was significantly lower than those who discontinued TNFi treatment (1 infection [0.2%] vs. 19 infections [1.3%]; adjusted risk ratio=0.2 [0.1–0.6]). Maternal rates of gestational diabetes, eclampsia/pre-eclampsia, small for gestational age (i.e., below the 10th percentile) and preterm births were similar between the patient groups.
These researchers found no statistically significant difference in negative fetal, maternal or infant outcomes for women with RA or SpA treated with a TNFi at pregnancy diagnosis when that TNFi treatment was maintained or discontinued. These results were from a relatively a small study group, and this study was not controlled. The different drugs, frequencies and overall durations were also not reported. However, these results provide insight into the idea that treating patients with TNFi while pregnant may prove more beneficial than stopping the therapy. More studies are needed to determine if these results can be duplicated when more controls are used.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.