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THU0157 Clinical Outcomes at Week 104 and Analysis of Associated Baseline Factors after An Initial 1 Year of Certolizumab Pegol and MTX Treatment in MTX-Naïve Patients with Early RA: Results from The Second Year of The C-Opera Study
  1. T. Atsumi1,
  2. K. Yamamoto2,
  3. T. Takeuchi3,
  4. H. Yamanaka4,
  5. N. Ishiguro5,
  6. Y. Tanaka6,
  7. K. Eguchi7,
  8. A. Watanabe8,
  9. H. Origasa9,
  10. T. Shoji10,
  11. O. Togo10,
  12. T. Okada11,
  13. D. van der Heijde12,
  14. N. Miyasaka13,
  15. T. Koike1,14
  1. 1Hokkaido University Graduate School of Medicine, Sapporo
  2. 2The University of Tokyo
  3. 3Keio University School of Medicine
  4. 4Tokyo Women's Medical University, Tokyo
  5. 5Nagoya University, Nagoya
  6. 6University of Occupational and Environmental Health, Kitakyushu
  7. 7Sasebo Chuo Hospital, Sasebo
  8. 8Tohoku University, Sendai
  9. 9University of Toyama School of Medicine, Toyama
  10. 10UCB Pharma
  11. 11Astellas Pharma Inc, Tokyo, Japan
  12. 12Leiden University Medical Center, Leiden, Netherlands
  13. 13Tokyo Medical and Dental University, Tokyo
  14. 14Sapporo Medical Center NTT EC, Sapporo, Japan

Abstract

Background The 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 have previously been reported (1-year [yr] results from the C-OPERA study).1

Objectives 1. Investigate whether the clinical impact of initial 1-yr treatment with CZP+MTX was maintained to Week (Wk) 104 with MTX therapy alone; 2. Identify factors associated with the final outcomes of the 2-yr therapy by post-hoc logistic regression analysis.

Methods MTX-naïve early RA pts were eligible to enter C-OPERA (NCT01451203). Pts were randomized to CZP+MTX (n=159) or placebo (PBO)+MTX (n=157); oral MTX was escalated to 16mg by Wk8, or maximum tolerated dose (optimized-dose). After pts completed the 52-wk double-blind (DB) period, CZP or PBO was discontinued and MTX monotherapy continued up to Wk104. Full analysis set population was analyzed using LOCF for SDAI remission, and linear extrapolation for mTSS in patients who withdrew before Wk104. Post-hoc univariate logistic regression analysis was used to investigate factors associated with radiographic non-progression (change from baseline [BL] in mTSS≤0.5 at Wk104) or SDAI remission at Wk104, and factors with p<0.1 were included in a multivariate analysis.

Results After stopping CZP at Wk52, the radiographic non-progression rate was higher at Wk104 in the Yr 1 CZP+MTX treatment group vs Yr 1 PBO+MTX treatment group (84.2% vs 67.5%, p<0.001). Although SDAI remission rates of the Yr 1 CZP+MTX treatment group decreased after CZP discontinuation, higher rates were maintained up to Wk104 vs PBO+MTX (41.5% vs 29.3%, p=0.026). Initial treatment with CZP, lower BL HAQ-DI and mTSS were considered to be associated with radiographic non-progression, whereas SDAI remission at Wk104 associated with male gender, lower BL DAS28(ESR) and initial treatment with CZP (Table). Incidence of overall adverse events was similar between groups, with no new safety signals.

Conclusions Primary analyses showed the clinical benefit of initial 1-yr CZP+MTX therapy in MTX-naïve early RA pts with poor prognostic factors was maintained to 2yrs with MTX alone. Different BL factors were identified as associated with clinical remission and radiographic non-progression. Effectiveness of initial 1-yr CZP treatment on both clinical and radiographic 2-yr outcomes was confirmed by multivariate logistic regression adjusting for BL factors.

  1. Atsumi T. Ann Rheum Dis 2016;75:75–83

Acknowledgement The authors acknowledge Costello Medical Consulting, funded by UCB Pharma, for writing and editorial assistance.

Disclosure of Interest T. Atsumi Speakers bureau: Astellas, Bristol-Myers Squibb, Chugai and Mitsubish-Tanabe, K. Yamamoto Grant/research support from: UCB Pharma, Pfizer, Abbott, Santen, Mitsubish-Tanabe and Eisai, Consultant for: UCB Pharma, Pfizer, Abbott, Bristol-Myers Squibb, Roche, Chugai, Mitsubish-Tanabe and Eisai, T. Takeuchi Grant/research support from: Abbott, Astellas, Bristol-Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Janssen, Mitsubish-Tanabe, Nippon Shinyaku, Otsuka, Pfizer, Sanofi-Aventis, Santen, Takeda and Teijin, Consultant for: AstraZeneca, Eli Lilly, Novartis, Mitsubishi-Tanabe and Asahi Kasei, Speakers bureau: UCB Pharma, Abbott, Bristol-Myers Squibb, Chugai, Eisai, Janssen, Mitsubishi-Tanabe, Pfizer and Takeda, H. Yamanaka Grant/research support from: UCB Pharma, Abbott, Astellas, Bristol-Myers Squibb, Chugai, Eisai, Janssen, Mitsubishi-Tanabe, Pfizer and Takeda, Consultant for: UCB Pharma, Abbott, Astellas, Bristol-Myers Squibb, Chugai, Eisai, Janssen, Mitsubishi-Tanabe, Pfizer and Takeda, N. Ishiguro Grant/research support from: Takeda, Mitsubishi-Tanabe, Astellas, Chugai, Abbott, Bristol-Myers Squibb, Eisai, Janssen, Kaken, and Pfizer, Speakers bureau: Takeda, Mitsubishi-Tanabe, Astellas, Chugai, Abbott, Bristol-Myers Squibb, Eisai, Janssen, Kaken, Pfizer, Taisho-Toyama and Otsuka, Y. Tanaka Grant/research support from: BMS, MSD, Chugai, Mitsubishi-Tanabe, Astellas, AbbVie and Daiichi-Sankyo, Consultant for: UCB Pharma, Mitsubishi-Tanabe, Abbott, AbbVie, Eisai, Chugai, Janssen, Pfizer, Takeda, Astellas, Daiichi-Sankyo, GSK, AstraZeneca, Eli Lilly, Quintiles, MSD and Asahi Kasei, K. Eguchi Grant/research support from: UCB Pharma, A. Watanabe Grant/research support from: Daiichi-Sankyo, Kyorin, Shionogi, Taisho, Dainippon-Sumitomo, Taiho, Toyama Chemical and Meiji Seika, Speakers bureau: MSD, GSK, Shionogi, Daiichi-Sankyo, Taisho-Toyama, Dainippon-Sumitomo, Mitsubishi-Tanabe and Pfizer, H. Origasa Consultant for: UCB Pharma and Astellas, T. Shoji Employee of: UCB Pharma, O. Togo Employee of: UCB Pharma, T. Okada Employee of: Astellas, D. van der Heijde Grant/research support 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 and Vertex, Consultant for: 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 and Vertex, Employee of: Imaging Rheumatology BV, N. Miyasaka Grant/research support from: Pfizer, Takeda, Mitsubishi-Tanabe, Chugai, Abbott, Eisai and Astellas, T. Koike Consultant for: AbbVie, Astellas, BMS, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, Pfizer, Santen, Taisho-Toyama, Takeda, Teijin and UCB Pharma, Speakers bureau: UCB Pharma, Pfizer, Chugai, Abbott, Mitsubishi-Tanabe, Takeda, Eisai, Santen, Astellas, Taisho-Toyama, BMS, Teijin and Daiichi-Sankyo

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