Zemprocitinib sustained clinical responses through Week 76 in rheumatoid arthritis after inadequate response to biologic therapy

1. Zemprocitinib improved the American College of Rheumatology 20% response (ACR20) versus placebo at Week 24 (p<0.0001) in adults with moderate-to-severe rheumatoid arthritis (RA).

2. Among patients receiving continuous zemprocitinib, ACR20 response was 91.8% at Week 76; Lynk Pharmaceuticals reported no new safety signals through that time point.

Evidence Rating Level: 2 (Good)

2MM Brief: Rheumatoid arthritis is a chronic inflammatory disease for which zemprocitinib is being evaluated in patients with inadequate response or intolerance to biologic therapy. Lynk Pharmaceuticals reported long-term results from COURAGE-RA, a randomized, double-blind, placebo-controlled Phase III study of 430 adults with moderate-to-severe active rheumatoid arthritis who had experienced inadequate response or intolerance to prior biologic disease-modifying antirheumatic drugs (bDMARDs); 429 received at least one dose. During the initial 24-week treatment period, participants received zemprocitinib 12 mg twice daily or placebo, after which they continued or transitioned to active treatment. The primary endpoint was the proportion achieving an ACR20 at Week 24. The study met this endpoint and key secondary endpoints, with statistically significant improvement for zemprocitinib versus placebo (p<0.0001). Among patients receiving continuous zemprocitinib, ACR20, American College of Rheumatology 50% response (ACR50) and American College of Rheumatology 70% response (ACR70) response rates at Week 76 were 91.8%, 80.5% and 62.4%, respectively. At that time point, 81.4% achieved low disease activity by Disease Activity Score 28 joints using C-reactive protein (DAS28(CRP)) (DAS28(CRP) ≤3.2), 81.0% by Clinical Disease Activity Index (CDAI) (CDAI ≤10), and 86.7% achieved an improvement of at least 0.22 points in the Health Assessment Questionnaire–Disability Index (HAQ-DI). Patients who switched from placebo at Week 24 also had Week 76 ACR20, ACR50 and ACR70 response rates of 92.0%, 77.6% and 55.1%. Lynk Pharmaceuticals reported that the safety profile remained consistent through Week 76, with no new safety signals; the release also described rare grade 3 or 4 alanine aminotransferase (ALT) elevations and grade 3 aspartate aminotransferase (AST) elevations. The results were not peer reviewed, and the release did not provide confidence intervals or detailed comparative Week 24 or Week 76 safety data. These findings support continued evaluation of zemprocitinib, although one company-reported study cannot establish its long-term comparative safety or efficacy.

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