Background Now, predictive factors at baseline for the good outcome of treatment with biologics are very important not to waste time to treatment goal “remission”.
Objectives The aims of this study are 1) to identify the predictive factors at baseline and 2) to clarify the importance of concomitant MTX to achieve the remission in treatment with tocilizumab (TCZ), IL-6 receptor antibody, in daily clinical practice.
Methods This study included 223 RA patients who received TCZ in the multicenter study group (Tsurumai Biologics Communication Registry; TBCR, 2176 cases treated with biologics were registered until 2011). We determined the predictive baseline factors for DAS28-ESR remission at week 52 using univariate and multivariate logistic regression analysis. In addition, we formulated a matrix model using the key factors associated with remission and low disease activity
Results Baseline characteristics: median(IQR); Age 60 ys (51-67), Disease duration 7.8 ys (3.7-14.3), DAS28-ESR 5.6 (4.9-6.5), concomitant MTX use 49.3 %, previous use of biologics 66.8 %. Univatiate analysis showed that concomitant MTX use had a significant impact on remission achievement in patients with higher disease activity and shorter disease duration. The multivariate logistic regression analysis showed a significant positive association between remission rate (DAS) at week 52 and the following baseline factors: no previous use of biologics [OR2.35 (1.26-4.43)], and lower DAS28-ESR (<5.6) [OR3.70 (2.07-6.76)]. Interestingly, in the patients with higher disease activity (DAS28-ESR (>5.6), concomitant MTX had a significant impact on achievement of remission [OR3.08 (1.24-8.18)] as well as no previous use of biologics [OR4.1 (1.59-11.2)]. Actually, matrix model using these baseline factors (cut-off= median) showed that TCZ and concomitant use of MTX could achieve high remission rates in patients who had shorter disease duration even with higher baseline DAS28-ESR, regardless of the history of biologics therapy (previous use 73 %, naïve 83%) while, in patients with lower disease activity, TCZ achieved high remission rate regardless of previous use of biologics, longer disease duration, concomitant MTX use (Fig.1).
Conclusions DAS28-ESR remission rates at week 52 in TCZ treatment were predictable by baseline factors in daily practice. Concomitant MTX should be important for the achievement of remission in the patients who need more aggressive intervention with poor prognostic factors such as higher disease activity, previous biologics use, and with shorter disease duration.
Disclosure of Interest T. Kojima Speakers bureau: Mitsubishi Tanabe Pharma Corporation, Takeda Pharma Corporation, Eisai Pharma Corporation, Chugai Pharma Corporation, Abbott, Bristol-Myers Squibb and Pfizer., N. Takahashi: None Declared, K. Funahashi: None Declared, D. Kato: None Declared, Y. Hattori: None Declared, M. Hanabayashi: None Declared, N. Asai: None Declared, N. Ishiguro Speakers bureau: Mitsubishi Tanabe Pharma Corporation, Takeda Pharma Corporation, Eisai Pharma Corporation, Chugai Pharma Corporation, Abbott, Bristol-Myers Squibb and Pfizer.