ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1636

Clinical Benefit of 1-Year Certolizumab Pegol Treatment in MTX-Naïve, Early Rheumatoid Arthritis Patients Is Maintained after Discontinuation up to 1 Year

Tatsuya Atsumi1, Kazuhiko Yamamoto2, Tsutomu Takeuchi3, Hisashi Yamanaka4, Naoki Ishiguro5, Yoshiya Tanaka6, Katsumi Eguchi7, Akira Watanabe8, Hideki Origasa9, Toshiharu Shoji10, Osamu Togo11, Toshiyuki Okada12, Désirée van der Heijde13, Nobuyuki Miyasaka14 and Takao Koike15, 1Division of Rheumatology, Endocrinology and Nephrology, Hokkaido University Graduate School of Medicine, Sapporo, Japan, 2Department of Allergy and Rheumatology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan, 3Keio University School of Medicine, Tokyo, Japan, 4Tokyo Women's Medical University, Tokyo, Japan, 5Department of Orthopedic Suregery, Nagoya University Hospital, Nagoya, Japan, 6The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, 7Department of Immunology and Rheumatology, Nagasaki University, Nagasaki, Japan, 8Tohoku University, Sendai, Japan, 9Division of Biostatistics and Clinical Epidemiology, University of Toyama School of Medicine, Toyama, Toyama, Japan, 10Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd, Shinagawa-ku, Tokyo, Japan, 11Biometrics Group, UCB Pharma, Tokyo, Japan, 12Astellas Pharma Inc., Japan, Tokyo, Japan, 13University Hospital, Maastricht, Netherlands, 14Tokyo Medical and Dental University, Tokyo, Japan, 15Medicine II, Hokkaido University Graduate School of Medicine, Sapporo, Japan

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: , , ,

Session Information

Date: Monday, November 9, 2015

Title: Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy Poster II

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

 

 

 

Disclosure: T. Atsumi, Astellas, Bristol-Myers Squibb, Chugai, Mitsubish-Tanabe, 8; K. Yamamoto, UCB Pharma, Pfizer, Abbott, Santen, Mitsubish-Tanabe, Eisai, 2,UCB Pharma, Pfizer, Abbott, Bristol-Myers Squibb, Roche, Chugai, Mitsubish-Tanabe, Eisai, 5; T. Takeuchi, AstraZeneca, Eli Lilly, Novartis, Mitsubishi-Tanabe, Asahi Kasei, 5,Abbott, Astellas, Bristol-Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Janssen, Mitsubish-Tanabe, Nippon Shinyaku, Otsuka, Pfizer, Sanofi-Aventis, Santen, Takeda, Teijin, 2,UCB Pharma, Abbott, Bristol-Myers Squibb, Chugai, Eisai, Janssen, Mitsubishi-Tanabe, Pfizer, Takeda, 8; H. Yamanaka, UCB Pharma, Abbott, Astellas, Bristol-Myers Squibb, Chugai, Eisai, Janssen, Mitsubishi-Tanabe, Pfizer, Takeda, 5,UCB Pharma, Abbott, Astellas, Bristol-Myers Squibb, Chugai, Eisai, Janssen, Mitsubishi-Tanabe, Pfizer, Takeda, 2; N. Ishiguro, Takeda, Mitsubishi-Tanabe, Astellas, Chugai, Abbott, Bristol-Myers Squibb, Eisai, Janssen, Kaken, Pfizer, 2,Takeda, Mitsubishi-Tanabe, Astellas, Chugai, Abbott, Bristol-Myers Squibb, Eisai, Janssen, Kaken, Pfizer, Taisho-Toyama, Otsuka, 8; Y. Tanaka, BMS, MSD, Chugai, Mitsubishi-Tanabe, Astellas, Abbvie, Daiichi-Sankyo, 2,UCB Pharma, Mitsubishi-Tanabe, Abbott, Abbvie, Eisai, Chugai, Janssen, Pfizer, Takeda, Astellas, Daiichi-Sankyo, GSK, AstraZeneca, Eli Lilly, Quintiles, MSD, Asahi Kasei, 5; K. Eguchi, UCB Pharma, 5; A. Watanabe, Daiichi-Sankyo, Kyorin, Shionogi, Taisho, Dainippon-Sumitomo, Taiho, Toyama Chemical, Meiji Seika, 2,MSD, GSK, Shionogi, Daiichi-Sankyo, Taisho-Toyama, Dainippon-Sumitomo, Mitsubishi-Tanabe, Pfizer, 8; H. Origasa, UCB Pharma, Astellas, 5; T. Shoji, UCB Pharma, 3; O. Togo, UCB Pharma, 3; T. Okada, Astellas, 3; D. van der Heijde, Abbvie, Amgen, AstraZeneca, Augurex, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Centocor, Chugai, Covagen, Daiichi, Eli-Lilly, Galapagos, GlaxoSmithKline, Janssen, Merck, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, UCB Pharma, Vertex, 5,Abbvie, Amgen, AstraZeneca, Augurex, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Centocor, Chugai, Covagen, Daiichi, Eli-Lilly, Galapagos, GlaxoSmithKline, Janssen, Merck, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, UCB Pharma, Vertex, 2; N. Miyasaka, Pfizer, Takeda, Mitsubishi-Tanabe, Chugai, Abbott, Eisai and Astellas, 2; T. Koike, Abbvie, Astellas, BMS, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, Pfizer, Santen, Taisho-Toyama, Takeda, Teijin, UCB. Speakers bureau: UCB Pharma, Pfizer, Chugai, Abbott, Mitsubishi-Tanabe, Takeda, Eisai, Santen, Astellas, Taisho-Toyama, BMS, Teiji, 5.

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 .

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