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(RA), according to results from a phase 2 clinical trial.
After 12 weeks, patients receiving peresolimab 700 mg saw a greater improvement in the primary endpoint of change in Disease Activity Score for 28 joints based on C-reactive protein (DAS28-CRP), compared with placebo.
“These results provide evidence that stimulation of the PD-1 receptor has potential efficacy in the treatment of rheumatoid arthritis,” said the authors, led by Jay Tuttle, PhD, of Eli Lilly and Company. The study was published in the New England Journal of Medicine.
A total of 98 patients with treatment-resistant, moderate to severe RA were enrolled in the double-blind, placebo-controlled trial. All patients had previously experienced treatment failure with biologic, targeted synthetic, or conventional synthetic disease-modifying antirheumatic drugs. Patients were randomized to receive 700 mg of peresolimab (49 patients), 300 mg of peresolimab (25 patients), or placebo (24 patients) intravenously once every 4 weeks.
Only patients taking peresolimab 700 mg had a significantly greater change in DAS28-CRP scores after 12 weeks, compared with placebo. In secondary outcomes, 71% of the 700-mg group experienced an improvement of at least 20% in American College of Rheumatology response criteria (ACR20), as compared with 42% in the placebo group. There was no difference between the placebo and peresolimab groups in ACR50 or ACR70 responses.
The safety profiles were similar across all three groups, although the 700-mg peresolimab group had numerically more adverse events (n = 14) than the 300-mg peresolimab group (n = 8) and the placebo group (n = 9). There were no severe adverse events reported during the study period. The authors noted that larger and longer studies are necessary to understand the safety of peresolimab.
“Careful evaluation of the effect of peresolimab on the risk of cancer will be important given the efficacy of PD-1 inhibitors in oncologic disease,” the authors wrote.
Eli Lilly funded the research. Researchers disclosed financial relationships with AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, and several other pharmaceutical companies.
(RA), according to results from a phase 2 clinical trial.
After 12 weeks, patients receiving peresolimab 700 mg saw a greater improvement in the primary endpoint of change in Disease Activity Score for 28 joints based on C-reactive protein (DAS28-CRP), compared with placebo.
“These results provide evidence that stimulation of the PD-1 receptor has potential efficacy in the treatment of rheumatoid arthritis,” said the authors, led by Jay Tuttle, PhD, of Eli Lilly and Company. The study was published in the New England Journal of Medicine.
A total of 98 patients with treatment-resistant, moderate to severe RA were enrolled in the double-blind, placebo-controlled trial. All patients had previously experienced treatment failure with biologic, targeted synthetic, or conventional synthetic disease-modifying antirheumatic drugs. Patients were randomized to receive 700 mg of peresolimab (49 patients), 300 mg of peresolimab (25 patients), or placebo (24 patients) intravenously once every 4 weeks.
Only patients taking peresolimab 700 mg had a significantly greater change in DAS28-CRP scores after 12 weeks, compared with placebo. In secondary outcomes, 71% of the 700-mg group experienced an improvement of at least 20% in American College of Rheumatology response criteria (ACR20), as compared with 42% in the placebo group. There was no difference between the placebo and peresolimab groups in ACR50 or ACR70 responses.
The safety profiles were similar across all three groups, although the 700-mg peresolimab group had numerically more adverse events (n = 14) than the 300-mg peresolimab group (n = 8) and the placebo group (n = 9). There were no severe adverse events reported during the study period. The authors noted that larger and longer studies are necessary to understand the safety of peresolimab.
“Careful evaluation of the effect of peresolimab on the risk of cancer will be important given the efficacy of PD-1 inhibitors in oncologic disease,” the authors wrote.
Eli Lilly funded the research. Researchers disclosed financial relationships with AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, and several other pharmaceutical companies.
(RA), according to results from a phase 2 clinical trial.
After 12 weeks, patients receiving peresolimab 700 mg saw a greater improvement in the primary endpoint of change in Disease Activity Score for 28 joints based on C-reactive protein (DAS28-CRP), compared with placebo.
“These results provide evidence that stimulation of the PD-1 receptor has potential efficacy in the treatment of rheumatoid arthritis,” said the authors, led by Jay Tuttle, PhD, of Eli Lilly and Company. The study was published in the New England Journal of Medicine.
A total of 98 patients with treatment-resistant, moderate to severe RA were enrolled in the double-blind, placebo-controlled trial. All patients had previously experienced treatment failure with biologic, targeted synthetic, or conventional synthetic disease-modifying antirheumatic drugs. Patients were randomized to receive 700 mg of peresolimab (49 patients), 300 mg of peresolimab (25 patients), or placebo (24 patients) intravenously once every 4 weeks.
Only patients taking peresolimab 700 mg had a significantly greater change in DAS28-CRP scores after 12 weeks, compared with placebo. In secondary outcomes, 71% of the 700-mg group experienced an improvement of at least 20% in American College of Rheumatology response criteria (ACR20), as compared with 42% in the placebo group. There was no difference between the placebo and peresolimab groups in ACR50 or ACR70 responses.
The safety profiles were similar across all three groups, although the 700-mg peresolimab group had numerically more adverse events (n = 14) than the 300-mg peresolimab group (n = 8) and the placebo group (n = 9). There were no severe adverse events reported during the study period. The authors noted that larger and longer studies are necessary to understand the safety of peresolimab.
“Careful evaluation of the effect of peresolimab on the risk of cancer will be important given the efficacy of PD-1 inhibitors in oncologic disease,” the authors wrote.
Eli Lilly funded the research. Researchers disclosed financial relationships with AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, and several other pharmaceutical companies.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE