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A subgroup analysis of the FINCH 2 study was carried to investigate the efficacy and safety of filgotinib (inhibitor of Janus kinase 1) in Japanese rheumatoid arthritis patients who have failed or were intolerant to one or more biologic DMARDs from the global FINCH 2 study.
In Japanese patients having active refractory
rheumatoid arthritis refractory to biologic disease-modifying antirheumatic
drugs (DMARDs) therapy, both doses of once-daily 200 mg filgotinib and 100 mg
filgotinib were found to be effective and showed good tolerability.
A subgroup analysis of the FINCH
2 study was carried to investigate the efficacy and safety of filgotinib
(inhibitor of Janus kinase 1) in Japanese rheumatoid arthritis patients who
have failed or were intolerant to one or more biologic DMARDs from the global
FINCH 2 study.
This study was carried out utilizing the predefined statistical analyses. The FINCH 2 study is a randomized, Phase 3, double-blind, placebo-controlled trial in adult rheumatoid arthritis patients with an unsatisfactory response to biological DMARDs. The randomized subjects were treated with once-daily 200 mg filgotinib, 100 mg filgotinib, or placebo on the background of conventional synthetic DMARDs for 24 weeks.
The primary outcome was the percentage of patients who attained an American
College of Rheumatology (ACR) 20% improvement (ACR20) response at week 12. The
secondary outcomes were: (i) Percentage of subjects who attained Disease
Activity Score for 28 joint count using C-reactive protein (DAS28-CRP) ≤ 3.2 at
week 12 (ii) Alterations from baseline at week 12 in the Health Assessment
Questionnaire-Disability Index (HAQ-DI) score (iii) Percentage of patients who
achieved DAS28-CRP < 2.6 at week 24 (or other time points) (iv) Alterations
from baseline at week 12 (or other time points) in 36-Item Short-Form Health
Survey (SF-36) Physical Component Summary (PCS) score and Functional Assessment
of Chronic Illness Therapy (FACIT)-Fatigue score.
Of 449 subjects recruited in the overall population, 40 subjects were recruited from Japan. At week 12, the ACR 20% response rates in the Japanese population for 200 mg filgotinib, 100 mg filgotinib, and placebo are shown in the following table:
Compared to placebo, filgotinib demonstrated a greater efficacy for all of the key secondary endpoints. Filgotinib displayed good tolerability, similar to the overall population.
Filgotinib is effective,
well-tolerated, and yields satisfactory outcomes in rheumatoid arthritis
patients.
Modern Rheumatology
Efficacy and safety of filgotinib in Japanese patients with refractory rheumatoid arthritis: Subgroup analyses of a global Phase 3 study (FINCH 2)
Tsutomu Takeuchi et al.
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