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.

Résumé

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