According to a report published by Tuttle et al in The New England Journal of Medicine, a 700-mg dose of the PD-1 agonist monoclonal antibody peresolimab resulted in a greater reduction in disease activity vs placebo in adult patients with moderate to severe rheumatoid arthritis who had previously received disease-modifying antirheumatic drugs. The phase IIa trial randomly assigned 98 eligible patients aged 18 years and older in a 2:1:1 ratio to receive either 700 mg of peresolimab, 300 mg of peresolimab, or placebo once every 4 weeks. The primary endpoint of the trial was the change from baseline to week 12 in the Disease Activity Score for 28 joints based on the C-reactive protein level (DAS28-CRP). At week 12, patients in the 700-mg group showed an improvement from baseline in terms of DAS28-CRP; no difference was seen between the 300-mg and placebo groups in terms of response. The researchers reported no trends in adverse events; one serious event was reported in the 700-mg group but was determined to be unrelated to the trial intervention. During the follow-up period, one patient in the 700-mg group was also reported to have experienced worsening of rheumatoid arthritis about 8 weeks after the final dose of peresolimab. The investigators concluded, “Peresolimab, at a dose of 700 mg, was superior to placebo with respect to the change from baseline in the DAS28-CRP at week 12. Longer and larger trials are needed to assess the efficacy and safety of peresolimab in rheumatoid arthritis.”
May 31, 2023