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SAT0257 Clinical and Radiographic Effects after 52-Week of Adding Tocilizumab or Switching to Tocilizumab in RA Patients with Inadequate Response to Methotrexate: Results from A Prospective Randomized Controlled Study (Surprise Study)
  1. T. Takeuchi1,
  2. Y. Kaneko1,
  3. T. Atsumi2,
  4. Y. Tanaka3,
  5. M. Inoh4,
  6. H. Kobayashi5,
  7. K. Amano6,
  8. M. Miyata7,
  9. Y. Murakawa8,
  10. T. Fujii9,
  11. A. Kawakami10,
  12. H. Yamanaka11,
  13. K. Yamamoto12,
  14. N. Miyasaka13,
  15. T. Mimori14,
  16. E. Tanaka11,
  17. H. Nagasawa6,
  18. H. Yasuoka1,
  19. S. Hirata3
  1. 1Division of Rheumatology, Department of Internal Medicine, Keio University, Tokyo
  2. 2Division of Rheumatology, Endocrinology and Nephrology, Hokkaido University Graduate School of Medicine, Hokkaido
  3. 3The First Department of Internal Medicine, School of Medicine, University of Occupational & Environmental Health, Japan, Fukuoka
  4. 4Internal Medicine, Utazu Hama Clinic, Kagawa
  5. 5Division of Rheumatology, Itabashi Medical Center, Tokyo
  6. 6Department of Rheumatology & Clinical Immunology, Saitama Medical Center, Saitama Medical University, Saitama
  7. 7Department of Internal Medicine, Fukushima Red-Cross Hospital, Fukushima
  8. 8Department of Rheumatology, Shimane University Faculty of Medicine, Shimane
  9. 9Department of Rheumatology and Clinical Immunology, Graduate School of Medicine, Kyoto University, Kyoto
  10. 10Unit of Translational Medicine, Department of Immunology and Rheumatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki
  11. 11Institute of Rheumatology, Tokyo Women's Medical University
  12. 12Department of Allergy and Rheumatology, The University of Tokyo Graduate School of Medicine
  13. 13Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo
  14. 14Department of Rheumatology and Clinical Immunology, Kyoto University Graduate School of Medicine, Kyoto, Japan

Abstract

Background The SURPRISE study is an open-label trial comparing the strategy of tocilizumab (TCZ) plus methotrexate (MTX) (ADD-ON) with the strategy of switching to TCZ (SWITCH) in Japanese rheumatoid arthritis (RA) patients with inadequate response to MTX (MTX-IR). Interim 24-wk data showed ADD-ON to be superior to SWITCH in efficacy as assessed using DAS28 remission criteria. Longer-term data including radiographic effect are needed to assess the 2 strategies over time.

Objectives To assess the 52-wk efficacy and safety of a TCZ-based adaptive treatment strategy with or without MTX in MTX-IR patients.

Methods Patients on stable doses of MTX were randomized to either add TCZ 8 mg/kg IV every 4 wks to their existing MTX or switch to TCZ 8 mg/kg IV every 4 wks. Factors related to disease activity were obtained at start of TCZ treatment (BL), and at wks 4, 8, 12, 24, and 52. X-rays were obtained at BL and wk 52. Modified total Sharp score (mTSS) was assigned by independent readers trained and competent to score radiographs and blind to the treatment. The last observation carried forward method was used.

Results Of 233 patients, 226 were in the full-analysis set (77.9% of whom completed 52 wks of treatment). BL data were similar between the 2 groups except for higher swollen joint counts in SWITCH. Efficacy results are shown in the table. Although DAS28 remission rate at wk 24 was significantly better in ADD-ON than in SWITCH (69.6% in ADD-ON, 55.0% in SWITCH), by wk 52 remission rate in SWITCH had caught up with that in ADD-ON, and there was no significant differences between the 2 groups. Most patients (66.3% in ADD-ON and 64.3% in SWITCH) had no radiographic progression from BL to wk 52. The percentage of patients whose ΔmTSS/year was ≥3.0 was numerically lower in ADD-ON than in SWITCH. Rates of serious adverse events and serious infections were numerically better for SWITCH: 14.0% and 5.2% in ADD-ON and 8.1% and 4.5% in SWITCH, respectively.

Table 1.

Week 52 efficacy results

Conclusions Clinical improvements at wk 52 were high and comparable between ADD-ON and SWITCH. Most patients showed no radiographic progression of structural damage. These data suggest that TCZ has a valuable treatment option for MTX-IR RA with or without MTX.

Acknowledgements All member of SURPRISE study group.

Disclosure of Interest T. Takeuchi Grant/research support: Abbott, Astellas, Bristol-Myers, Chugai, Daiichi Sankyo, Eisai, Janssen, Mitsubishi Tanabe, Pfizer, Sanofi, Santen, Takeda, Teijin, abbvie, Asahikasei, Taisho Toyama., Consultant for: Astra Zeneca Eli Lilly, Novartis, Mitsubishi Tanabe, Asahi Kasei, abbivie, Daiichi Sankyo., Paid instructor for: Abbott, Bristol-Myers, Chugai, Eisai, Janssen, Mitsubishi Tanabe, Pfizer, Takeda, Astellas, Diaichi Sankyo., Y. Kaneko: None declared, T. Atsumi Grant/research support: Kyowa Hakko Kirin, Chugai, Novartis, Mitsubishi Tanabe, Teijin, MSD, Astellas, Sanofi, Takeda, Novo Nordisk, Otsuka, BoehringerIngelheim, Abbvie, Kissey, Pfizer, Shionogi, Dainippon Sumitomo, TaisyoToyama, Bristol-Myers, GlaxoSmithKline, Acterion., Paid instructor for: Astellas, Acterion, Abbvie, Eisai, MSD, Asahikasei, Otsuka, Daiichi Sankyo, Mitsubishi Tanabe, Takeda, Chugai, Pfizer,Bristol-Myers., Y. Tanaka Grant/research support: Bristol-Myers, MSD, Chugai, Mitsubishi Tanabe, Astellas, Abbvie, Eisai, Janssen., Speakers bureau: Mitsubishi Tanabe, Abbvie, Eisai, Chugai, Janssen, Santen, Pfizer, Astellas, Daiichi Sankyo, GlaxoSmithKline, Astra Zeneca, Otsuka, Actelion, Eli Lilly, Nippon Kayaku, UCB, Quintiles, Ono., M. Inoh: None declared, H. Kobayashi: None declared, K. Amano Grant/research support: Chugai, Mitsubishi Tanabe, Astellas, Eisai, Abbvie., M. Miyata: None declared, Y. Murakawa Grant/research support: Astellas, Chugai, Eisai, Mitsubishi Tanabe, Takeda, Teijin., Paid instructor for: Abbvie, Actelion, Astellas, Bristol-Myers, Chugai, Janssen, Mitsubishi Tanabe, Ono, Pfizer, Santen, Takeda, Teijin, UCB., T. Fujii Grant/research support: Chugai., A. Kawakami Grant/research support: Chugai, Mitsubishi Tanabe, Pfizer, Takeda, Abbvie, Eisai, Bristol-Myers, Janssen, Astellas, Santen,Taisho Toyama, Asahi Kasei., Paid instructor for: Chugai, Mitsubishi Tanabe, Pfizer, Takeda, Abbvie, Eisai, Bristol-Myers, Janssen, Astellas, Santen,Taisho Toyama, Asahi Kasei., H. Yamanaka Grant/research support: Abbvie, Bristol-Myers, Chugai, Eisai, Janssen, Mitsubishi Tanabe, Otsuka, Pfizer, Takeda, UCB., Paid instructor for: Abbvie, Bristol-Myers, Chugai, Eisai, Janssen, Mitsubishi Tanabe, Otsuka, Pfizer, Takeda, UCB., K. Yamamoto Grant/research support: Immunofuture Inc., N. Miyasaka Grant/research support: Abbvie, Astellas, Banyu, Chugai, Daiichi Sankyo, Eisai, Janssen, Mitsubishi Tanabe, Takeda, Teijin., T. Mimori Grant/research support: Asahi Kasei, Astellas, Bristol-Myers, Chugai, Eisai, Mitsubishi Tanabe, Pfizer, Santen, Takeda., Speakers bureau: Bristol-Myers, Chugai, Mitsubishi Tanabe., E. Tanaka: None declared, H. Nagasawa: None declared, H. Yasuoka: None declared, S. Hirata: None declared

DOI 10.1136/annrheumdis-2014-eular.2439

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