THU0092 The advantage of early intervention by tocilizumab for rheumatoid arthritis - full analysis of all-case postmarketing surveillance in 7,901 patients in japan:
Authors: H. Yamanaka, M. Harigai, S. Inokuma, N. Ishiguro, J. Ryu, S. Takei, T. Takeuchi, Y. Tanaka, Y. Sano, T. Koike
Journal: Annals of the Rheumatic Diseases (2013)

<h3>Background</h3> 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. <h3>Objectives</h3> 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. <h3>Methods</h3> 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. <h3>Results</h3> 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 &lt;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 &lt;2 years than in patients whose disease duration was ≥10 years (p&lt;0.0001, χ<sup>2</sup> test). Same results were obtained irrespective of the previous use of TNF inhibitor (p&lt;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&lt;0.0001, χ<sup>2</sup> 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 &lt;2 years (p&lt;0.0001, χ<sup>2</sup> 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 &lt;2 years (p&lt;0.0001, χ<sup>2</sup> 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. <h3>Conclusions</h3> 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. <h3>Disclosure of Interest</h3> 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