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Peresolimab belongs to a humanized immunoglobulin (Ig)G1 monoclonal antibody that binds to human PD-1 and acts as an agonist, inhibiting lymphocyte activation and expansion
.
Peresolimab binding to PD-1 is expected to stimulate physiological immunosuppressive pathways that restore immune regulation, which holds promise as a new approach
to treating patients with autoimmune or autoinflammatory diseases.
In this phase 2a, double-blind, randomized controlled trial (NCT04634253), researchers evaluated Peresolimab in moderately to severely active rheumatoid arthritis (RA).
Efficacy and safety in adult patients who have previously underresponded to
conventional (csDMARDs), biological (bDMARDs), or synthetic (tsDMARDS) drugs.
In addition, the treatment group and placebo groups were usually compared with the placebo group using a repeated-measure mixed-effects model (MMRM) and a binomial logistic regression model
.
The results showed that a total of 121 patients were enrolled and randomized to receive 2:1:1 intravenous Peresolimab 700 mg (n = 49), 300 Milligram (n = 25) or placebo (n = 24) Q4W, 98 participants received at least one dose of study treatment and were included in the analysis
。 The majority (83.
7%) of patients were female, with a mean age at baseline of 51.
7 (12.
6) years
.
At baseline, the mean duration of RA was 10.
0 (8.
0) years and the DAS28-CRP score was 5.
9 （0.
85）
。
The trial met the primary endpoint of DAS28-CRP in patients treated with 700 mg and 300 mg of Peresolimab compared to placebo treatment at two test doses There was a significant improvement in scoring (Figure 1a).
It was further found that patients treated with any dose of Peresolimab had significant improvements in CDAI
.
In addition, patients treated with 700 mg of Peresolimab achieved a significantly higher proportion of ACR20 at week 12 (Table 1 ）
。 At the same time, in patients who achieved low disease activity in CDAI at week 14, efficacy was maintained until week
24.
The demonstrated safety and tolerability of Peresolimab in the treatment of patients with RA supports further clinical evaluation
of immune diseases.
In summary, Peresolimab demonstrated safety and tolerability in the treatment of RA patients, superior to placebo
at several key endpoints at week 12.
In the future, it is necessary to further evaluate the efficacy of Peresolimab in the treatment of autoimmune diseases, make breakthroughs as soon as possible, and bring new treatment options
to more patients with autoimmune diseases.
Resources
https://acrabstracts.
org/abstract/a-phase-2-trial-of-peresolimab-for-adults-with-rheumatoid-arthritis/
