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SAT0100 Abatacept Biologic-Free Remission Study in Established Rheumatoid Arthritis Patients orion Study
  1. T. Takeuchi on behalf of ORION study group1,
  2. T. Matsubara2,
  3. S. Ohta3,
  4. M. Mukai4,
  5. K. Amano5,
  6. S. Tohma6,
  7. Y. Tanaka7,
  8. H. Yamanaka8,
  9. N. Miyasaka ORION study group9
  1. 1Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo
  2. 2Orthopedics, Matsubara Mayflower Hospital, Hyogo
  3. 3Department of Rheumatology, Taga General Hospital, Hitachi
  4. 4Division of Rheumatology & Clinical Immunology, Department of Medicine, Sapporo City General Hospital, Sapporo
  5. 5Division of Rheumatology and Clinical Immunology, Department of Internal Medicine, Saitama Medical Center, Saitama Medical University, Saitama
  6. 6Clinical Research Center for Allergy and Rheumatology, Sagamihara National Hospital, National Hospital Organization, Sagamihara
  7. 7The First Department of Internal Medicine, School of Medicine, University of Occupational And Environmental Health Hospital, Kitakyushu
  8. 8Institute of Rheumatology, Tokyo Women’s Medical University
  9. 9Department of Medicine and Rheumatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan

Abstract

Background Evidence suggests that biologic-free remission is achievable with TNF inhibitors1, 2 and abatacept (ABA) 3. Orencia® Remission Induction and Outcome Navigation (ORION) is the first study to show the potential utility of ABA in promoting biologic-free remission.

Objectives To evaluate and explore the potential of ABA for promoting biologic-free remission in RA patients in clinical remission.

Methods ORION was a multi-center, non-randomized, 52-week, prospective observational study involving RA patients who achieved DAS28-CRP<2.3 at the end of a Japanese phase II/III study. ABA was continued or discontinued at the patients’ discretion. ABA treatment was restarted during the 52-week follow-up period in patients who experienced disease flare (DAS28-CRP>2.7 at 2 consecutive visits) or at the decision of the attending physician.

Results A total of 51 RA patients were enrolled in the study, 34 of whom discontinued ABA treatment while the remaining 17 continued. The mean age of the discontinuation and continuation groups was 56.9±11.4 and 60.9±9.5 years, mean disease duration at entry was 6.4±5.1 and 12.0±10.5 years. At week 52, 41.2% of the discontinuation group and 64.7% of the continuation group reached remission (DAS28-CRP<2.3). 58.8% of the discontinuation group reached low disease activity (LDA, DAS28-CRP<2.7) at week 52 (ITT population, last observational carried forward method). HAQ-DI (p=0.036) and CRP level (p=0.048) at the entry of ORION were associated with LDA at week 52. Twenty-eight in the discontinuation and 17 in the continuation groups were available and evaluable x-ray data. 14.3% in the discontinuation group indicated rapid radiographic progression (RRP; increase of mTSS≥5 units per year). We noted a significant difference in CRP level at entry of ORION and RF level at entry of phase III between patients with and without RRP (CRP [mg/dL]; RRP 0.5±0.4, non-RRP 0.3±0.4 [p=0.03], RF [IU/mL]; RRP 19.0±18.3, non-RRP 125.1±164.9 [p=0.02]).

Conclusions Patients treated with ABA who reached remission were able to discontinue treatment.

References

  1. Tanaka et al., Ann Rheum Dis 2010; 69:1286–1291

  2. van der Kooij et al., Ann Rheum Dis 2009; 68:914–921

  3. Takeuchi et al., Arthritis & Rheumatism 64, 10 (SUPPLEMENT) S552, 2012

Disclosure of Interest T. Takeuchi Grant/research support from: Abott Japan Co., LTD., Astellas Pharma, Bristol-Myers K.K., Chugai Pharmaceutical Co., LTD., Daiichi Sankyo Co., LTD., Eisai Co., LTD., Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma Co., Nippon Shinyaku Co., LTD., Otsuka Pharmaceutical, Pfizer Japan Inc., Sanofi-aventis K.K., Santen Pharmaceutical, Takeda Pharmaceutical Co., LTD., Teijin Phrma Ltd., Consultant for: Astra Zeneca, K.K., Eli-Lilly Japan K.K., Novartis Pharma K.K., Mitsubishi Tanabe Pharma Co., Asahi Kasei Medical K.K., Speakers bureau: Abott Japan Co., LTD., Bristol-Myers K.K., Chugai Pharmaceutical Co., LTD., Eisai Co., LTD., Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Takeda Pharmaceutical Co., LTD., T. Matsubara Grant/research support from: Santen Pharmaceutical, Co., Ltd., Bristol-Myers K.K., Otsuka Pharmaceutical Co., Ltd., Takeda Chemical Industries, Ltd., Eli Lilly Japan K.K., Quintiles Transnational Japan K.K., Astellas Pharma Inc., Astra Zeneca K.K., PAREXEL International, Nippon Kayaku Co., Ltd., Consultant for: Santen Pharmaceutical, Co., Ltd., Bristol-Myers K.K., Pfizer Japan Inc., Janssen Pharmaceutical K.K., Abbott Japan Co., Ltd., Eisai Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd., Asahi Kasei Pharma Corporation, Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Corporation, S. Ohta: None Declared, M. Mukai: None Declared, K. Amano Consultant for: Bristol -Myers Squibb co., S. Tohma Grant/research support from: Mitsubishi Tanabe Pharma Corporation., Astellas Pharma Inc., Chugai Pharmaceutical Co. Ltd., Abbott Japan Co., Ltd, Y. Tanaka Grant/research support from: Bristol-Myers Squibb, MSD K.K., Chugai Pharma Co., Ltd., Mitsubishi-Tanabe Pharma Co., Ltd., Astellas Pharma Inc., Abbott Japan Co., Ltd., Eisai Co., Ltd. and Janssen Pharmaceutical K.K., Consultant for: Mitsubishi-Tanabe Pharma Co., Ltd., Abbott Japan Co., Ltd., Eisai Co., Ltd., Chugai Pharma Co., Ltd., Janssen Pharma K.K., Santen Pharma Co., Ltd., Pfizer Japan Inc., Astellas Pharma Inc., Daiichi-Sankyo Co., Ltd., GlaxoSmithKlineK.K., Astra-Zeneca, Otsuka Pharma Co., Ltd., Actelion Pharma Japan Ltd., Eli Lilly Japan K.K., Nippon Kayaku Co., Ltd., UCB Japan Co., Ltd., Quintiles Transnational Japan Co. Ltd., Ono Pharma Co., Ltd., and Novartis Pharma K.K, Speakers bureau: Mitsubishi-Tanabe Pharma Co., Ltd., Abbott Japan Co., Ltd., Eisai Co., Ltd., Chugai Pharma Co., Ltd., Janssen Pharma K.K., Santen Pharma Co., Ltd., Pfizer Japan Inc., Astellas Pharma Inc., Daiichi-Sankyo Co., Ltd., GlaxoSmithKlineK.K., Astra-Zeneca, Otsuka Pharma Co., Ltd., Actelion Pharma Japan Ltd., Eli Lilly Japan K.K., Nippon Kayaku Co., Ltd., UCB Japan Co., Ltd., Quintiles Transnational Japan Co. Ltd., Ono Pharma Co., Ltd., and Novartis Pharma K.K, H. Yamanaka Grant/research support from: Abbott, Astellas, Bristol-Myers Squibb, Chugai, Eisai, Janssen, Mitsubishi-Tanabe, Pfizer, Takeda, UCB, Consultant for: Abbott, Astellas, Bristol-Myers Squibb, Chugai, Eisai, Janssen, Mitsubishi-Tanabe, Pfizer, Takeda, UCB, Consultant for: Abbott, Astellas, Bristol-Myers Squibb, Chugai, Eisai, Janssen, Mitsubishi-Tanabe, Pfizer, Takeda, UCB, Consultant for: Abbott, Astellas, Bristol-Myers Squibb, Chugai, Eisai, Janssen, Mitsubishi-Tanabe, Pfizer, Takeda, UCB, N. Miyasaka Grant/research support from: Chugai Pharmaceutical Co., Tanabe-Mitsubishi Pharmaceutical Co., Takeda Pharmaceutical Co., Pfizer Japan, Abbott Japan, Eisai Pharmaceutical Co., Astellas Pharmaceutical Co., Bristol-Myers-Squibb.

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