Date: Monday, November 9, 2015
Session Type: ACR Poster Session B
Session Time: 9:00AM-11:00AM
Background/Purpose: Efficacy and safety of certolizumab pegol (CZP) treatment in combination with optimized-dose MTX in Japanese MTX-naïve early rheumatoid arthritis (RA) patients (pts) with poor prognostic factors has previously been reported.1 Here we report 2-year data from the C-OPERA study, investigating maintenance of clinical effect after discontinuing CZP treatment in an observational post-treatment period while continuing MTX treatment.
Methods: MTX-naïve pts with early RA (defined as ≤12 months from onset of persistent symptoms) fulfilling the 2010 ACR/EULAR classification criteria and poor prognostic factors were eligible to enter C-OPERA; a multicenter, double-blind (DB), randomized study (NCT01451203). Pts were randomized to CZP+MTX (n=159) or placebo (PBO)+MTX (n=157) with oral MTX escalated up to 16 mg by Week (Wk) 8 (optimized dose), if tolerated. After completing 52-wk DB period, CZP (n=108) or PBO (n=71) was discontinued and pts continued with MTX monotherapy up to Wk104 in 52-wk post CZP-treatment period. Pts who were in DAS(ESR) ≥3.2 for two consecutive visits (4 wks) or longer after Wk24 could receive rescue treatment with CZP and were excluded from the post-CZP treatment period. Full analysis set (FAS) population was analyzed. Last observation carried forward (LOCF) imputation was used for missing data for clinical remission, whereas linear extrapolation was employed to estimate mTSS in patients who withdrew before Wk104.
Results: In CZP+MTX→MTX group, SDAI remission rate was decreased over the initial 16 weeks from 57.9% to 44.9% after CZP discontinuation. However, the rate remained stable thereafter, with higher rate of SDAI remission compared with PBO+MTX→MTX up to Wk104 (41.5% vs 29.3%; p=0.026 [Figure A]). Similar trend was observed in DAS28(ESR) and Boolean remission. Pts retreated with CZP due to flare after CZP discontinuation (n=28) showed rapid clinical improvement after CZP retreatment. The CZP+MTX→MTX group showed significantly less radiographic progression at Wk104 (mean change from baseline (CFB) in mTSS: 0.66±5.38 vs 3.01±9.66; p=0.001 [Figure B]) with higher non-radiographic progression rate (CFB in mTSS≤0.5) (84.2% vs 67.5%; p<0.001). Incidence of overall adverse events was similar between groups, with no new or unexpected safety signals.
Conclusion: The clinical benefit of initial 1-year CZP treatment in MTX-naïve early RA patients was still observed after discontinuing CZP for an additional 1 year while continuing optimized MTX monotherapy.
Reference: 1. Atsumi T. Ann Rheum Dis 2014;73(S2):484
To cite this abstract in AMA style:Atsumi T, Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N, Tanaka Y, Eguchi K, Watanabe A, Origasa H, Shoji T, Togo O, Okada T, van der Heijde D, Miyasaka N, Koike T. Clinical Benefit of 1-Year Certolizumab Pegol Treatment in MTX-Naïve, Early Rheumatoid Arthritis Patients Is Maintained after Discontinuation up to 1 Year [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/clinical-benefit-of-1-year-certolizumab-pegol-treatment-in-mtx-naive-early-rheumatoid-arthritis-patients-is-maintained-after-discontinuation-up-to-1-year/. Accessed October 16, 2021.
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