ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 3226

Maintenance of Clinical Remission and Radiographic Non-Progression with MTX after Completion of 1 Year Initial Treatment with Certolizumab Pegol in Japanese Patients with Early Rheumatoid Arthritis

Yoshiya Tanaka1, Tatsuya Atsumi2, Kazuhiko Yamamoto3, Tsutomu Takeuchi4, Hisashi Yamanaka5, Naoki Ishiguro6, Katsumi Eguchi7, Akira Watanabe8, Hideki Origasa9, Toshiharu Shoji10, Pauline Ralston11, Désirée van der Heijde12, Nobuyuki Miyasaka13,14 and Takao Koike15, 1University of Occupational and Environmental Health, Kitakyushu, Japan, 2Division of Rheumatology, Endocrinology and Nephrology, Hokkaido University Graduate School of Medicine, Sapporo, Japan, 3The University of Tokyo, Tokyo, Japan, 4Division of Rheumatology, Keio University School of Medicine, Tokyo, Japan, 5Tokyo Women's Medical University, Tokyo, Japan, 6Nagoya University, Nagoya, Japan, 7Department of Rheumatology, Sasebo Chuo Hospital, Sasebo, Japan, 8Tohoku University, Sendai, Japan, 9Division of Biostatistics and Clinical Epidemiology, University of Toyama School of Medicine, Toyama, Japan, 10UCB Pharma, Tokyo, Japan, 11Hays Pharma, London, United Kingdom, 12Leiden University Medical Center, Leiden, Netherlands, 13Department of Medicine and Rheumatology, Tokyo Medical and Dental University, Tokyo, Japan, 14Tokyo Medical and Dental University, Tokyo, Japan, 15Sapporo Medical Center NTT EC, Sapporo, Japan

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: , ,

Session Information

Date: Wednesday, November 16, 2016

Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy V: New Biologics and Remission Induction

Session Type: ACR Concurrent Abstract Session

Session Time: 11:00AM-12:30PM

Background/Purpose: The efficacy and safety of certolizumab pegol (CZP) treatment in combination with dose-optimized MTX in Japanese MTX-naïve early RA patients (pts) with poor prognostic factors have previously been reported.1 Here, we report the factors at Week (Wk) 52 associated with the maintenance of clinical remission and radiographic non-progression after discontinuation of CZP treatment to Wk 104.

Methods: MTX-naïve early RA pts entered C-OPERA (NCT01451203)1 and were randomized to CZP+MTX (n=159) or placebo (PBO)+MTX (n=157); oral MTX was escalated to 16 mg/wk by Wk 8, if tolerated (optimized MTX). After completing the 52-wk double-blind period, CZP or PBO was discontinued and MTX therapy continued up to Wk 104 (post-treatment [PT] period; CZP+MTX→MTX). All pts (n=108) who were initially randomized to CZP+MTX and entered the PT period were included in these analyses. Clinical disease activity, remission (SDAI, DAS28[ESR], Boolean, at Wks 52 and 104), and radiographic non-progression rates (change from baseline [BL] or Wk 52 ≤0.5 in van der Heijde modified Total Sharp Score [mTSS], joint erosion score, and joint space narrowing score) were calculated. Missing values used last observation carried forward (LOCF) for remission and linear extrapolation for radiographic outcomes. Post-hoc logistic regression analyses were used to investigate the Wk 52 factors (DAS28[ESR], HAQ-DI, mTSS, rheumatoid factor [RF], anti-CCP antibody, and MMP-3) associated with remission and radiographic non-progression. Factors with p<0.1 in univariate analyses were included in multivariate analyses.

Results: At Wk 52, 77.8%, 79.6%, and 61.1% pts were in DAS28(ESR), SDAI, and Boolean remission, respectively. Remission rates decreased from Wk 52 to Wk 104 after stopping CZP, although most pts maintained remission (Figure A). Over 90% pts who entered the PT period achieved radiographic non-progression during CZP+MTX treatment; the non-progression rate was maintained after stopping CZP from Wks 52–104 (Figure B). In sensitivity analyses, DAS28(ESR) at Wk 52 was associated with DAS28(ESR), SDAI, and Boolean remission at Wk 104 (odds ratio: 0.23, 0.29, 0.36); Wk 52 RF was associated with SDAI and Boolean remission at Wk 104 (odds ratio: 0.67 and 0.69) (Table).

Conclusion: Clinical remission can be maintained up to an additional 52 wks after CZP discontinuation in early RA pts with poor prognostic factors. Both low disease activity and low RF at CZP discontinuation (Wk 52) were associated with the maintenance of clinical remission. Radiographic non-progression was observed even after CZP discontinuation at Wk 52. References: 1. Atsumi T. Ann Rheum Dis 2016;75(1):75–83

Disclosure: Y. Tanaka, Bristol-Myers Squibb, MSD, Chugai, Mitsubishi-Tanabe, Astellas, AbbVie, Daiichi-Sankyo, 2,UCB Pharma, Mitsubishi-Tanabe, Abbott, AbbVie, Eisai, Chugai, Janssen, Pfizer, Takeda, Astellas, Daiichi-Sankyo, GlaxoSmithKline, AstraZeneca, Eli Lilly, Quintiles, MSD, Asahi Kasei, 5; T. Atsumi, Astellas, Bristol-Myers Squibb, Chugai, Mitsubishi-Tanabe, 8; K. Yamamoto, UCB Pharma, Pfizer, Abbott, Santen, Mitsubishi-Tanabe, Eisai, 2,UCB Pharma, Pfizer, Abbott, Bristol-Myers Squibb, Roche, Chugai, Mitsubishi-Tanabe, Eisai, 5; T. Takeuchi, Abbott, Astellas, Bristol-Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Janssen, Mitsubishi-Tanabe, Nippon Shinyaku, Otsuka, Pfizer, Sanofi-Aventis, Santen, Takeda, Teijin, 2,from AstraZeneca, Eli Lilly, Novartis, Mitsubishi-Tanabe, Asahi Kasei, 5,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, 2,UCB Pharma, Abbott, Astellas, Bristol-Myers Squibb, Chugai, Eisai, Janssen, Mitsubishi-Tanabe, Pfizer, Takeda, 5; 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; K. Eguchi, UCB Pharma, 5; A. Watanabe, Daiichi-Sankyo, Kyorin, Shionogi, Taisho, Dainippon-Sumitomo, Taiho, Toyama Chemical, Meiji Seika, 2,MSD, GlaxoSmithKline, Shionogi, Daiichi-Sankyo, Taisho-Toyama, Dainippon-Sumitomo, Mitsubishi-Tanabe, Pfizer, 8; H. Origasa, UCB Pharma, Astellas, 5; T. Shoji, UCB Pharma, 3; P. Ralston, Hays Pharma, 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, 2,from 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, Vert, 5,Imaging Rheumatology BV, 3; N. Miyasaka, from Pfizer, Takeda, Mitsubishi-Tanabe, Chugai, Abbott, Eisai, Astellas, 2; T. Koike, AbbVie, Astellas, Bristol-Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, Pfizer, Santen, Taisho-Toyama, Takeda, Teijin, UCB Pharma, 5,UCB Pharma, Pfizer, Chugai, Abbott, Mitsubishi-Tanabe, Takeda, Eisai, Santen, Astellas, Taisho-Toyama, Bristol-Myers Squibb, Teijin, Daiichi-Sankyo, 8.

To cite this abstract in AMA style:

Tanaka Y, Atsumi T, Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N, Eguchi K, Watanabe A, Origasa H, Shoji T, Ralston P, van der Heijde D, Miyasaka N, Koike T. Maintenance of Clinical Remission and Radiographic Non-Progression with MTX after Completion of 1 Year Initial Treatment with Certolizumab Pegol in Japanese Patients with Early Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/maintenance-of-clinical-remission-and-radiographic-non-progression-with-mtx-after-completion-of-1-year-initial-treatment-with-certolizumab-pegol-in-japanese-patients-with-early-rheumatoid-arthritis/. Accessed .

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