Anti-TNF Treatment Trial Encouraging for High-Risk APS Pregnancies
HSS rheumatologist Jane E. Salmon, MD discussed new evidence derived by small numbers of the Phase II IMPACT (Improve Pregnancy in APS with Certolizumab Therapy) trial, which suggests treatment with the TNF-inhibitor certolizumab could help improve high-risk pregnancy outcomes in women with antiphospholipid syndrome (with or without systemic lupus erythematosus) and lupus anticoagulants.
Dr. Salmon, who is also the co-lead of the IMPACT trial, presented this new line of research during the Rheumatology Research Foundation Memorial Lectureship session, to honor Shaun Ruddy, MD, at the virtual American College of Rheumatology annual meeting.
Certolizumab is already approved for the treatment of rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis and Crohn’s disease, and isn’t transferred across the placenta. Doses of certolizumab were similar to those used in RA and Crohn’s disease, with the first dose at eight weeks and six days of gestation to target abnormal development of the placenta, which starts early and is usually found at 12–15 weeks. Certolizumab is discontinued at 28 weeks, after which benefit is unlikely.
With a trial target of 50 participants, 27 patients have been enrolled, 23 of whom have completed pregnancies that can be evaluated. Only three—or 13%—of the women experienced a primary outcome, far lower than the 44% expected. One fetal death occurred at 10.3 weeks of gestation, along with two cases of preeclampsia with births at less than 34 weeks.
“Though it’s a small number, we are quite optimistic and looking forward to continuing the trial,” said Dr. Salmon. “Treatments to prevent poor pregnancy outcomes require an understanding of mechanisms of injury, and one needs animal studies and human observational studies to develop that understanding. But one can apply that understanding to test new treatments, and that’s—in fact—what we’re doing.”
Read the full article at the-rheumatologist.org.
Additional coverage: the-rheumatologist.org