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THU0092 The advantage of early intervention by tocilizumab for rheumatoid arthritis - full analysis of all-case postmarketing surveillance in 7,901 patients in japan
  1. H. Yamanaka1,
  2. M. Harigai2,
  3. S. Inokuma3,
  4. N. Ishiguro4,
  5. J. Ryu5,
  6. S. Takei6,
  7. T. Takeuchi7,
  8. Y. Tanaka8,
  9. Y. Sano9,
  10. T. Koike10
  1. 1Institute of Rheumatology, Tokyo Women’s Medical University
  2. 2Tokyo Medical and Dental Univ
  3. 3Japanese Red Cross Medical Center, Tokyo
  4. 4Nagoya University, Graduate School & Faculty of Medicine, Nagoya
  5. 5Nihon University School of Medicine, Tokyo
  6. 6School of Health Sciences, Kagoshima University, Kagoshima
  7. 7Keio University School of Medicine, Tokyo
  8. 8University of Occupational & Environmental Health, Kitakyushu
  9. 9Chugai Pharmaceutical Co. Ltd, Tokyo
  10. 10Sapporo medical center NTT EC, Sapporo, Japan

Abstract

Background Tocilizumab (TCZ), a humanized anti-human interleukin-6 receptor monoclonal antibody, has been approved worldwide for rheumatoid arthritis (RA), and an all-case postmarketing surveillance (PMS) program was conducted in Japan.

Objectives The aim of this surveillance is to investigate the safety and effectiveness of TCZ for the treatment of rheumatoid arthritis (RA) in the daily clinical setting.

Methods This full analysis report includes 7,901 patients who received TCZ at a dose of 8 mg/kg every 4 weeks, and were observed for 28 weeks.

Results Baseline characteristics included: mean age 58.7 years old (≥70 years in 20.7%); mean disease duration 10.4 years (≥10 years in 37.6%); previous TNF inhibitor use in 62.6%, concomitant methotrexate (MTX) use in 55.8% and concomitant glucocorticoid use in 74.0%. The mean DAS28-ESR improved from 5.5 at baseline to 2.9 at week 28 (LOCF method) with TCZ treatment; 47.6% of patients achieved DAS28 remission (DAS28-ESR <2.6), and 15.1% of patients achieved Boolean remission. The DAS28 remission rate and Boolean remission rate were significantly higher in patients whose disease duration was <2 years than in patients whose disease duration was ≥10 years (p<0.0001, χ2 test). Same results were obtained irrespective of the previous use of TNF inhibitor (p<0.0001 for both remission criteria in both TNF inhibitor-naïve and TNF inhibitor-used patients). However, TNF inhibitor-naïve patients showed significantly better response than the TNF inhibitor-used patients (p<0.0001, χ2 test). The incidence rates of all adverse events and serious adverse events (AEs and SAEs) were 43.9% and 9.6%, respectively. The incidence rate of SAEs was significantly lower in patients whose disease duration was <2 years (p<0.0001, χ2 test, vs. ≥10 years). Infections were the most frequent AE (11.1%) and SAE (3.8%). The incidence rates of infections and serious infections were significantly lower in the patients whose disease duration was <2 years (p<0.0001, χ2 test, vs.≥10 years). Similar results were observed when comparing the incidence of serious respiratory infections, which are the most common site-specific infection and serious infection, by disease duration.

Conclusions Theseresults demonstratedthat treatment with TCZ was effective and well-tolerated in Japanese RA patients in the daily clinical setting, and also suggested that TCZ can be used more effectively and safely in anti-TNF naïve RA patients with shorterdisease duration than in patients with established disease.

Disclosure of Interest H. Yamanaka Grant/Research support from: Abbott, Bristol-Myers Squibb, Chugai, Janssen, Eisai, Mitsubishi-Tanabe, Otsuka, Takeda, Pfizer, Consultant for: Abbott, Bristol-Myers Squibb, Chugai, Hoffmann-La Roche, Janssen, Eisai, Mitsubishi-Tanabe, Otsuka, Takeda, Pfizer, M. Harigai Grant/Research support from: Abbott Japan Co. Ltd., Bristol-Myers Japan, Chugai Pharmaceutical Co. Ltd., Eisai Co. Ltd., Mitsubishi Tanabe Pharma Corp., Pfizer Japan Inc., Takeda Pharmaceutical Co. Ltd., Consultant for: Abbott Japan Co. Ltd., Chugai Pharmaceutical Company, Janssen Pharmaceutical KK, Mitsubishi Tanabe Pharma Corp, S. Inokuma: None Declared, N. Ishiguro Grant/Research support from: Abbott Japan Co. Ltd., Bristol-Myers Japan, Chugai Pharmaceutical Co. Ltd., Eisai Co. Ltd., Mitsubishi Tanabe Pharma Corp., Pfizer Japan Inc., Takeda Pharmaceutical Co. Ltd., Speakers Bureau: Chugai, Eisai, Astellas, Mitsubishi-Tanabe, Takeda, J. Ryu: None Declared, S. Takei: None Declared, T. Takeuchi Consultant for: Abbott Immunology Pharmaceuticals, AstraZeneca, Bristol-Myers Squibb, Chugai, Astellas, Mitsubishi-Tanabe, Pfizer, Takeda, Y. Tanaka Consultant for: Abbott Immunology Pharmaceuticals, Chugai, Eisai, Astellas, Mitsubishi-Tanabe, Takeda, Y. Sano Employee of: Chugai, T. Koike Consultant for: Abbott Immunology Pharmaceuticals, Bristol-Myers Squibb,Astellas, Otsuka, Speakers Bureau: Abbott Immunology Pharmaceuticals, Chugai, Eisai, Mitsubishi-Tanabe, Takeda, Pfizer

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