AB0590 Rates of treatment continuation and remission in 97 patients with high c-reactive protein receiving tocilizumab: 2-year study based on the tsurumai biologics communication registry
Authors: Y. Yabe, T. Kojima, A. Kaneko, Y. Kanayama, T. Shioura, N. Asai, T. Kobayakawa, K. Saito, N. Ishiguro
Journal: Annals of the Rheumatic Diseases (2013)

<h3>Background</h3> Tocilizumab (TCZ) inhibits IL-6 signal transduction and directly affects production of C-reactive protein (CRP). <h3>Objectives</h3> To examine the effects on continuation and remission rates after attaining negative CRP following TCZ administration in patients who had high CRP level before TCZ administration. <h3>Methods</h3> Ninety-seven RA patients in the Tsurumai Biologics Communication Registry who had high CRP level (1 mg/dL or more) before starting TCZ administration for whom 24-month follow-up were available. The 97 subjects were stratified into 2 groups: the negative group (0.3&gt; group) consisting of 74 subjects with CRP of less than 0.3 mg/dL after 6 months of TCZ treatment, and the non-negative group (0.3≤ group) consisting of the other 23 subjects. Continuation rate and efficacy were examined before and after 6, 12 and 24 months of TCZ treatment. DAS28-ESR &lt;2.6 (DAS remission) and Boolean definition ALL ≤1 (Tender Joint Count ≤1, Swollen Joint Count ≤1, PtGA ≤1 cm, and CRP ≤1 mg/dL) were taken as remission (Boolean remission). Subjects who discontinued TCZ treatment were considered non-remission using non-responder imputation. The two groups were compared using Fisher's exact test and Wilcoxon rank sum test. <h3>Results</h3> Baseline characteristics of the 97 subjects were 57±13 years of age (mean ± sd), disease duration of 121±100 months (mean ± sd), percent previous use of biologics of 69% and pre-treatment DAS28-ESR of 6.1±1.2 (mean ± sd). There was a significant difference between the 0.3&gt; group and the 0.3≤ group in the pre-treatment dosage of concomitant prednisolone (5.0 mg/day in the 0.3&gt; group, 8.3 in the 0.3≤ group, p=0.04) and in the pre-treatment PtGA (5.5 in the 0.3&gt; group, 7.7 in the 0.3≤ group, p&lt;0.01). In the 0.3&gt; group, the continuation rate was 100% after 6 months, 91% after 12 months and 80% after 24 months, DAS remission was seen in 26 subjects (35%) after 6 months, 30 (41%) after 12 months and 23 (31%) after 24 months, and Boolean remission was seen in 5 subjects (7%) after 6 months, 9 (12%) after 12 months and 8 (11%) after 24 months.In the 0.3≤ group, the continuation rate was 48% after 6 months, 35% after 12 months and 26% after 24 months, DAS remission was seen in 1 subject (4%) after 6 and 12 months, and 2 (0%) after 24 months, and Boolean remission was seen in 0 subjects (0%) after 6, 12 and 24 months. There was a significant difference between the 0.3&gt; group and the 0.3≤ group in the continuation rate and DAS remission after 6, 12 and 24 months (p&lt;0.05 for all), but no significant difference in Boolean remission after 6, 12 and 24 months. Administration was discontinued due to inadequate response for 5 subjects in the 0.3&gt; group and for 3 subjects in the 0.3≤ group. <h3>Conclusions</h3> If CRP is turned to negative within 6 months of treatment in patients with high CRP before TCZ treatment, continuation and DAS remission can possibly be expected thereafter. However, fewer subjects attained Boolean remission than DAS remission. This is possibly because of a large number of subjects with long disease duration and a history of biologics treatment included in this study. <h3>Disclosure of Interest</h3> Y. Yabe: None Declared, T. Kojima Speakers Bureau: from Eisai Co. Ltd, Abbot Japan Co. Ltd, Mitsubishi Tanabe Pharma Corporation, Daiichi Sankyo Pharmaceutical, Pfizer Japan, Takeda Pharmaceutical, 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., Y. Kanayama: None Declared, T. Shioura: None Declared, N. Asai: None Declared, T. Kobayakawa: None Declared, K. Saito: None Declared, N. Ishiguro Speakers Bureau: from Eisai Co. Ltd, Abbot Japan Co. Ltd, Mitsubishi Tanabe Pharma Corporation, Daiichi Sankyo Pharmaceutical, Pfizer Japan, Takeda Pharmaceutical, and Chugai Phamaceutical Co. Ltd.