TOPLINE: Stimulation of the PD-1 pathway with the investigational drug peresolimab shows efficacy in treating rheumatoid arthritis (RA).
METHODOLOGY:
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Peresolimab is a humanized monoclonal antibody that stimulates human programmed cell death protein 1 (PD-1).
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Researchers enrolled 98 adults with treatment-resistant, moderate-to-severe RA in the phase 2, double-blind, placebo-controlled trial.
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Patients were randomly assigned to receive 700 mg of peresolimab, 300 mg of peresolimab, or placebo intravenously once every 4 weeks.
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The primary outcome was the change in the Disease Activity Score in 28 Joints based on the C-reactive protein level (DAS28-CRP) from baseline to 12 weeks.
TAKEAWAY:
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Only patients taking 700 mg of peresolimab had a significantly greater change in DAS28-CRP, compared with the placebo group after 12 weeks.
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The 700-mg group had a greater percentage of ACR20 responses, but not ACR50 or ACR70 responses, compared with placebo.
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The safety profiles were similar across the peresolimab and placebo groups.
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Peresolimab should be evaluated for its effect on cancer risk because the monoclonal antibody does the opposite of anticancer therapies blocking PD-1 activity.
IN PRACTICE:
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This study is too preliminary to have practice application.
STUDY DETAILS:
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Jay Tuttle, PhD, of Eli Lilly and Company (San Diego, California) led the research. The study was published today in The New England Journal of Medicine.
LIMITATIONS:
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The trial’s small sample size and short timeframe could limit the interpretation of the results.
DISCLOSURES:
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Eli Lilly funded the research. Researchers disclosed financial relationships with AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, and several other pharmaceutical companies.
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