Do high rheumatoid factor levels impact response to certolizumab pegol in patients with inadequately controlled rheumatoid arthritis? A post hoc analysis of the phase IIIb REALISTIC trial

RMD Open 2026 Open access

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Authors: Josef S Smolen, T. Mikuls, James Galloway, Ulf Müller-Ladner, J. Randall Curtis, Motomu Hashimoto, Tsutomu Takeuchi, Ernest Choy, Yoshiya Tanaka, Carlos Cara, Bernard Lauwerys, Nicola Tilt
+2 more Baran Ufuktepe, Peter C. Taylor
DOI: 10.1136/rmdopen-2025-006094
Cited by: 2
References: 32

Abstract

OBJECTIVES: To assess the impact of rheumatoid factor (RF) levels and previous inadequate responses/intolerance to tumour necrosis factor inhibitors (TNFi-IR) on the efficacy of certolizumab pegol (CZP) in patients with rheumatoid arthritis (RA) through a post hoc analysis of the RA Evaluation in Subjects Receiving TNF Inhibitor CZP (REALISTIC) trial. METHODS: In the phase IIIb REALISTIC trial, patients with RA were randomised to CZP (400 mg at weeks 0, 2 and 4, then 200 mg every 2 weeks) or placebo (PBO) for 12 weeks, followed by open-label CZP (minimum 16 weeks). Outcomes reported to week 36 include Disease Activity Score 28 C-reactive protein (DAS28-CRP) and Clinical Disease Activity Index (CDAI) scores, rates of DAS28-CRP

Fields of Study & Subjects

Rheumatoid Arthritis Research and Therapies Spondyloarthritis Studies and Treatments Autoimmune and Inflammatory Disorders Research

Publication details

Journal / source
RMD Open
Publisher
BMJ
Volume
12
Issue
1
Pages
e006094–e006094
Publication date
1 January 2026
Language
EN