Disease-modifying antirheumatic drugs have been a cornerstone in treating RA, according to Ajay Nirula, MD, PhD. However, in a significant number of patients, their response often diminishes over time. “Despite major advances in treatment for RA in recent decades, considerable unmet needs remain,” Dr. Nirula says. “Many patients do not respond to currently available therapies. Even with those patients who do respond, a relatively small proportion achieve significant improvement or enter disease remission. Our study evaluated peresolimab, a monoclonal IgG1 antibody that has potential to satisfy some of these major unmet needs.”
For a randomized controlled study published in the New England Journal of Medicine, Dr. Nirula and colleagues enrolled approximately 100 patients with RA at clinical sites around the world. Participants were treated with one of two doses of peresolimab or placebo for up to 24 weeks. The primary endpoint was efficacy at 12 weeks of treatment. Additional evaluations of efficacy and safety and tolerability were made at various timepoints up to 24 weeks.
The analysis found that peresolimab was more efficacious than placebo at reducing the Disease Activity Score and inflammatory markers often elevated in RA. However, the long-term safety profile of peresolimab use beyond 12 weeks remains unclear.
The study represents the first evaluation of efficacy and safety of peresolimab in RA, but as Dr. Nirula points out, the results should be interpreted with caution due to the small study size. “Despite that, an encouraging level of efficacy was seen with peresolimab after 12 weeks, which demonstrated superiority to placebo on the study’s primary efficacy measure,” he says. “One of the significant unmet needs for patients with RA is to find new therapies for those who have failed or lost response to existing approved advanced therapies. Encouragingly, many patients in the study who had been treated before with such therapies experienced improvement on peresolimab.”
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