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
Authors: N. Asai, T. Kobayakawa, K. Saito, T. Shioura, Y. Yabe, T. Kojima, A. Kaneko, N. Ishiguro
Journal: Annals of the Rheumatic Diseases (2013)

<h3>Background</h3> 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. <h3>Objectives</h3> To examine the effect of the PtGA improvement after 6 months of treatment on the remission rate thereafter in patients receiving Tocilizumab(TCZ). <h3>Methods</h3> 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%&gt; 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 &lt;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. <h3>Results</h3> 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%&gt; 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%&gt; 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&lt;0.05 for all). <h3>Conclusions</h3> 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. <h3>Disclosure of Interest</h3> 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.