Trial reportClinical rheumatology2026
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.
Trial report in Clinical rheumatology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04333771 (A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Moderate to Severe Active Rheumatoid Arthritis Subjects With Inadequate Response to csDMARDs.), which is not on this map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Moderate to Severe Active Rheumatoid Arthritis Subjects With Inadequate Response to csDMARDs.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesIvarmacitinib (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.
methodsPatients 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.
resultsIvarmacitinib 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.
conclusionIvarmacitinib 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.
Indexed as
Identifiers
41922627What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.