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- Title
Post hoc analysis of clinical characteristics of patients with radiographic progression in a Japanese phase 3 trial of peficitinib and methotrexate treatment (RAJ4).
- Authors
Yoshiya Tanaka; Tsutomu Takeuchi; Daisuke Kato; Yuichiro Kaneko; Musashi Fukuda; Hiroyuki Izutsu; Mitsuhiro Rokuda; van der Heijde, Désirée
- Abstract
Objective: To determine the efficacy of peficitinib in reducing joint damage and predictive factors affecting treatment response in Japanese patients with rheumatoid arthritis. Methods: This post hoc analysis used data from a placebo-controlled, phase 3 trial (RAJ4) of peficitinib in patients with rheumatoid arthritis and inadequate response to methotrexate. Erosion and joint space narrowing (JSN) were assessed at baseline and at Week 28/early termination of treatment using the van der Heijde-modified Sharp method. A univariate logistic regression analysis of change from baseline in a modified total Sharp score identified predictive factors with significant treatment interaction; the effects of these factors on treatment response were further evaluated using a multivariate model. Results: The analyses included 481 patients. For most joint groups, peficitinib demonstrated a reduced change from baseline at Week 28/early termination in erosion and JSN scores versus placebo; a numerically greater effect was observed with peficitinib 150 mg versus 100 mg. Baseline C-reactive protein (CRP) and prednisolone dose were identified as clinically significant negative predictive factors: the treatment effect decreased as CRP or prednisolone dose increased for both peficitinib doses. Conclusions: Peficitinib 100 mg and 150 mg reduced joint damage versus placebo, across almost all joint groups. Higher baseline CRP and/or prednisolone dose were associated with reduced peficitinib efficacy.
- Subjects
CLINICAL trials; TERMINATION of treatment; METHOTREXATE; LOGISTIC regression analysis; PREDNISOLONE; RHEUMATOID arthritis
- Publication
Modern Rheumatology, 2023, Vol 33, Issue 1, p73
- ISSN
1439-7595
- Publication type
Article
- DOI
10.1093/mr/roac021