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AB0564 Continuation and remission rates of tocilizumab treatment based on improvement in patient global assessment: 2-year study based on the tsurumai biologics communication registry
  1. N. Asai1,
  2. T. Kobayakawa2,
  3. K. Saito3,
  4. T. Shioura4,
  5. Y. Yabe5,
  6. T. Kojima1,
  7. A. Kaneko6,
  8. N. Ishiguro1
  1. 1Orthopedic Surgery, Nagoya University School of Medicine, Nagoya
  2. 2Rheumatology, Nagano Red Cross Hospital, Nagano
  3. 3Orthopedic Surgery and Rheumatology, Saito Clinic, Nagoya
  4. 4Orthopedic Surgery, Shizuoka Kousei Hospital, Shizuoka
  5. 5Rheumatology, KoseiNenkin Hospital, Tokyo
  6. 6Orthopedic Surgery and Rheumatology, Nagoya Medical Center, Nagoya, Japan

Abstract

Background Improvement in Patient Global Assessment (PtGA) is reported to have a large influence on remission by the Boolean definition in the new remission standards proposed by ACR/EULAR in 2011.

Objectives To examine the effect of the PtGA improvement after 6 months of treatment on the remission rate thereafter in patients receiving Tocilizumab(TCZ).

Methods The subjects were 113 patients from among 129 rheumatoid arthritis patients in the Tsurumai Biologics Communication Registry for whom follow-up for 24 months after TCZ administration was available, excluding 16 patients who discontinued administration within 6 months due to adverse events or other reasons. The 113 subjects were stratified into three groups based on the change in PtGA from baseline after 6 months of TCZ administration: the 50%≤ group consisting of 36 subjects who showed improvement of 50% or more, the 50%> group consisting of 54 subjects who showed improvement of less than 50%, and the deterioration group consisting of 21 subjects who showed deterioration or no change. Continuation rate and efficacy were examined after 12 and 24 months of TCZ treatment. DAS28-ESR <2.6 (DAS remission) and Boolean definition ALL ≤1 (Boolean remission) were taken as remission. Subjects who discontinued TCZ treatment were considered non-remission using non-responder imputation.

Results The baseline characteristics of the 113 subjects were 56.9±12.8 years of age (mean ± sd), disease duration of 125.0±105.0 months, percent previous use of biologics of 65.5%, pre-treatment PtGA of 5.5±2.4 cm and pre-treatment DAS28-ESR of 5.7±1.3. There was a significant difference between the three groups in disease duration (94.6 months in the 50%≤ group, 147.9 months in the 50%> group, 118.8 months in the deterioration group, p=0.013). In the 50%≤ group, the continuation rate was 83.3% after 12 months and 77.8% after 24 months, DAS remission rate was 50.0% after 12 months and 52.8% after 24 months, and Boolean remission rate was 27.8% after 12 months and 22.2% after 24 months. In the 50%> group, the continuation rate was 90.7% after 12 months and 79.6% after 24 months, DAS remission rate was 38.9% after 12 months and 27.8% after 24 months, and Boolean remission rate was seen in 5.6% after 12 months and 7.4% after 24 months. In the deterioration group, the continuation rate was 78.2% after 12 months and 65.2% after 24 months, DAS remission rate was 17.4% after 12 months and 14.5% after 24 months, and Boolean remission rate was 0% after both 12 and 24 months. A significant difference was observed between the three groups in DAS remission and Boolean remission after 12 and 24 months (p<0.05 for all).

Conclusions Within 6 months of TCZ treatment, the remission rate was high in subjects that showed PtGA improvement of 50% or more, and remission-oriented treatment was given, while in subjects who showed PtGA improvement of less than 50%, the high continuation rate suggested that treatment was continued with low disease activity as the goal of treatment. If PtGA is unchanged or deteriorated within 6 months, other treatment strategies, including surgical therapy, should probably be considered.

Disclosure of Interest N. Asai: None Declared, T. Kobayakawa: None Declared, K. Saito: None Declared, T. Shioura: None Declared, Y. Yabe: None Declared, T. Kojima Speakers Bureau: from Brisrol- Myers Scuibb, Eisai Co. Ltd, Abbot Japan Co. Ltd, Mitsubishi Tanabe Pharma Corporation and Chugai Phamaceutical Co. Ltd., A. Kaneko Speakers Bureau: from Eisai Co. Ltd, Abbot Japan Co. Ltd, Mitsubishi Tanabe Pharma Corporation and Chugai Phamaceutical Co. Ltd., N. Ishiguro Speakers Bureau: from Brisrol-Myers Scuibb, Eisai Co. Ltd, Abbot Japan Co. Ltd, Mitsubishi Tanabe Pharma Corporation and Chugai Phamaceutical Co. Ltd.

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