Clinical rheumatology · 2026
Effect of ivarmacitinib on patient-reported outcomes in patients with moderate-to-severe active rheumatoid arthritis: a post-hoc analysis of a phase III trial.
СтатьяКлиническое исследование III фазыРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Xia Nannan, Zhu Lijuan, Zhang Weifeng, Zhang Luyue, Feng Lixin, Ren Zhijuan, Luo Yuqing, Wang Nan, Yang Lei, Dai Haixue, Yin Shanshan, Lu Tan
Аннотация
OBJECTIVES: Ivarmacitinib (SHR0302), a selective Janus kinase 1 inhibitor, has demonstrated efficacy and safety in patients with moderate-to-severe rheumatoid arthritis (RA) who exhibited inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs-IR) by a phase III clinical trial (NCT04333771). This post-hoc study focused on patient-reported outcomes (PROs) using the data of this trial, aiming to comprehensively assess the treatment's impact on patients' quality-of-life and symptom perception.
METHODS: Patients were randomized (1:1:1) to receive once daily ivarmacitinib 4 mg (N = 189), ivarmacitinib 8 mg (N = 189) or placebo (N = 188). At week 24, patients with placebo switched to ivarmacitinib 4 mg for an additional 28 weeks, while the others continued their initial dosage. PROs included morning stiffness duration and severity, Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient Global Assessment of Disease Activity (PtGA), 36-Item Short Form Health Survey (SF-36), and pain by visual analog scale.
RESULTS: Ivarmacitinib 4 mg and 8 mg demonstrated significantly higher rates of HAQ-DI improvement ≥ 0.22 compared to placebo from week 2 to 24 (all P < 0.05). Meanwhile, ivarmacitinib 4 mg and 8 mg significantly improved morning stiffness duration and severity, HAQ-DI score, SF-36 physical and mental component score, PtGA, and pain at week 24 compared to placebo (all P < 0.05). From week 24 to 52, all PROs were sustainedly improved by ivarmacitinib 4 and 8 mg; patients who switched from placebo to ivarmacitinib 4 mg at week 24 also achieved substantial improvements in PROs.
CONCLUSION: Ivarmacitinib significantly and sustained improves PROs in patients with moderate-to-severe RA with csDMARDs-IR. Key Points • In patients with moderate-to-severe RA with csDMARDs-IR, ivarmacitinib, a novel selective JAK-1 inhibitor, improved various dimensions of PROs compared with placebo, including patient-reported symptoms of RA, overall physical functioning, quality-of-life, and spiritual well-being. • From week 24 to week 52, patients who switched from placebo to ivarmacitinib experienced substantial improvements in all PROs. • From week 24 to week 52, patients who continued ivarmacitinib treatment showed sustained improvements in PROs.
METHODS: Patients were randomized (1:1:1) to receive once daily ivarmacitinib 4 mg (N = 189), ivarmacitinib 8 mg (N = 189) or placebo (N = 188). At week 24, patients with placebo switched to ivarmacitinib 4 mg for an additional 28 weeks, while the others continued their initial dosage. PROs included morning stiffness duration and severity, Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient Global Assessment of Disease Activity (PtGA), 36-Item Short Form Health Survey (SF-36), and pain by visual analog scale.
RESULTS: Ivarmacitinib 4 mg and 8 mg demonstrated significantly higher rates of HAQ-DI improvement ≥ 0.22 compared to placebo from week 2 to 24 (all P < 0.05). Meanwhile, ivarmacitinib 4 mg and 8 mg significantly improved morning stiffness duration and severity, HAQ-DI score, SF-36 physical and mental component score, PtGA, and pain at week 24 compared to placebo (all P < 0.05). From week 24 to 52, all PROs were sustainedly improved by ivarmacitinib 4 and 8 mg; patients who switched from placebo to ivarmacitinib 4 mg at week 24 also achieved substantial improvements in PROs.
CONCLUSION: Ivarmacitinib significantly and sustained improves PROs in patients with moderate-to-severe RA with csDMARDs-IR. Key Points • In patients with moderate-to-severe RA with csDMARDs-IR, ivarmacitinib, a novel selective JAK-1 inhibitor, improved various dimensions of PROs compared with placebo, including patient-reported symptoms of RA, overall physical functioning, quality-of-life, and spiritual well-being. • From week 24 to week 52, patients who switched from placebo to ivarmacitinib experienced substantial improvements in all PROs. • From week 24 to week 52, patients who continued ivarmacitinib treatment showed sustained improvements in PROs.