Efficacy and safety of abatacept in biologic-naïve patients with active rheumatoid arthritis by background methotrexate dose: post hoc analysis of a randomized, placebo-controlled, phase 4 study.

Abstract

OBJECTIVES:

The objective of this study is to evaluate efficacy and safety of abatacept in biologic-naïve, anti-citrullinated protein antibody (ACPA)-positive Japanese patients with active rheumatoid arthritis (RA) by background methotrexate (MTX) dose.

METHODS:

In this post hoc analysis of a randomized, double-blind, placebo-controlled phase 4 study (NCT01758198), patients received intravenous abatacept (∼10 mg/kg) or placebo both with MTX (≥6 mg/week). Efficacy (Disease Activity Score 28 using C-reactive protein [DAS28 (CRP)] and Health Assessment Questionnaire-Disability Index [HAQ-DI]) was assessed by baseline MTX dosage (≤8 and >8 mg/week) to week 16; safety was assessed by MTX dosage ≤8 and >8 mg/week. Change from baseline in DAS28 (CRP) and HAQ-DI was assessed using longitudinal repeated measures analysis.

RESULTS:

Overall, 101 and 102 patients received abatacept + MTX ≤8 and >8 mg/week, while 96 and 106 patients received placebo + MTX ≤8 and >8 mg/week, respectively. Regardless of baseline MTX dose received, mean changes from baseline in DAS28 (CRP) and HAQ-DI in abatacept groups were similar; repeated measures analysis showed similar trends in changes from baseline in DAS28 (CRP) and HAQ-DI. Abatacept safety profile was consistent with previous observations.

CONCLUSIONS:

Post hoc analysis demonstrated similar efficacy and safety of abatacept in biologic-naïve ACPA-positive Japanese patients with RA regardless of baseline MTX dose.

• Authors: Yoshiya Tanaka, Tsukasa Matsubara, Koichi Hashizume, Norihito Amano, Tsutomu Takeuchi
• Journal: Modern rheumatology (Mod Rheumatol) Vol. 32 Issue 3 Pg. 500-507 (Apr 18 2022) ISSN: 1439-7609 [Electronic] England
• PMID: 34897499 (Publication Type: Clinical Trial, Phase IV, Journal Article, Randomized Controlled Trial)
• Copyright: © Japan College of Rheumatology 2021. Published by Oxford University Press.

Chemical References

• Antirheumatic Agents
• Abatacept
• C-Reactive Protein
• Methotrexate

Topics

• Abatacept (adverse effects)
• Antirheumatic Agents (adverse effects)
• Arthritis, Rheumatoid (drug therapy)
• C-Reactive Protein
• Double-Blind Method
• Drug Therapy, Combination
• Humans
• Methotrexate (adverse effects)
• Treatment Outcome