POS0541 Effect of Ivarmacitinib on patient-reported outcomes in patients with moderate-to-severe active rheumatoid arthritis and inadequate response to conventional synthetic DMARDs: a post hoc analysis of a phase III trial

Abstract

Background:

Ivarmacitinib (SHR0302), a selective Janus kinase 1 inhibitor, has demonstrated efficacy in patients with moderate-to-severe rheumatoid arthritis (RA) who have inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs).

Objectives:

This post-hoc study focuses on the impact of Ivarmacitinib on patient-reported outcomes (PROs).

Methods:

This study was a post-hoc analysis derived from a phase III clinical trial (NCT04333771) [1]. Patients were randomized to receive Ivarmacitinib 4 mg (n=189), Ivarmacitinib 8 mg (n=189) or placebo (n=188) once daily. After 24 weeks, patients with placebo switched to 4 mg Ivarmacitinib, while the others continued their regimen. PROs included morning stiffness duration and severity, Health Assessment Questionnaire-Disability Index (HAQ-DI), 36-Item Short Form Health Survey (SF-36), Patient Global Assessment of Disease Activity (PtGA) and pain by visual analog scale.

Results:

At week 24, patients treated with Ivarmacitinib 4 mg and 8 mg showed significant improvements in morning stiffness duration and severity, PtGA, and pain compared to those with placebo (all P<0.05, Figure 1). Differences between the placebo-Ivarmacitinib 4 mg group and Ivarmacitinib groups diminished gradually from week 24 to week 52. Furthermore, Ivarmacitinib 4 mg and 8 mg groups exhibited significant improvements in HAQ-DI score, SF-36 physical or mental component score compared to placebo group at week 24 (all P<0.05, Figure 2); similarly, the differences between the placebo-Ivarmacitinib 4 mg group and Ivarmacitinib groups gradually diminished by week 52.

Conclusion:

Ivarmacitinib significantly and sustained improves patient-reported outcomes in patients with moderate-to-severe RA who have not responded well to csDMARDs.

REFERENCES:

[1] Liu J, Jiang Y, Zhang S, et al. Ivarmacitinib, a selective Janus kinase 1 inhibitor, in patients with moderate-to-severe active rheumatoid arthritis and inadequate response to conventional synthetic DMARDs: results from a phase III randomised clinical trial. Ann Rheum Dis. Published online November 27, 2024. doi:10.1136/ard-2024-226385 Figure 1Comparison of the changes in morning stiffness duration (A), severity (B), PtGA (C), and change in pain (D) from baseline among groups. *, P<0.05 for Ivarmacitinib 4 mg vs placebo; **, P<0.01 for Ivarmacitinib 4 mg vs placebo; ***, P<0.001 for Ivarmacitinib 4 mg vs placebo; #, P<0.05 for Ivarmacitinib 8 mg vs placebo; ##, P<0.01 for Ivarmacitinib 8 mg vs placebo; ###, P<0.001 for Ivarmacitinib 8 mg vs placebo. Figure 2Comparison of the changes in HAQ-DI score (A), SF-36 physical component score (B), and SF-36 mental component score (C) from baseline among groups. *, P<0.05 for Ivarmacitinib 4 mg vs placebo; ***, P<0.001 for Ivarmacitinib 4 mg vs placebo; #, P<0.05 for Ivarmacitinib 8 mg vs placebo; ##, P<0.01 for Ivarmacitinib 8 mg vs placebo; ###, P<0.001 for Ivarmacitinib 8 mg vs placebo.

Acknowledgements:

NIL.

Disclosure of Interests:

None declared. © The Authors 2025. This abstract is an open access article published in Annals of Rheumatic Diseases under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Neither EULAR nor the publisher make any representation as to the accuracy of the content. The authors are solely responsible for the content in their abstract including accuracy of the facts, statements, results, conclusion, citing resources etc.