Background/Purpose: Now, predictive factors at baseline for the good outcome of treatment with biologics are very important not to waste time to treatment goal “remission”. It is still arguable how to use glucocorticoid (GC) in treatment strategy of rheumatoid arthritis (RA). Another critical question would be whether MTX is even needed for better clinical outcomes during TCZ treatment in clinical settings with a variety of baseline characteristics, including previous use of other biologics.  The aims of this study are 1) to identify the predictive factors at baseline and 2) to clarify the meaning of concomitant use of GC as well as MTX to achieve the remission in treatment with tocilizumab (TCZ), especially with background of limited dose of MTX(≤8mg/week). 

Methods: This study included 240 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 explored the differences in baseline characteristics by concomitant use of GC. We also determined the predictive baseline factors for remission (DAS28) at week 52 using multivariate logistic regression analysis.

Results: In Japan, dose of MTX is limited up to 8mg/week until 2011. Baseline characteristics: median (IQR); Age 60 ys (51-67), Disease duration 8.1 ys (3.7-14.5), DAS28-ESR 5.6 (4.8-6.5), MTX dose 8mg(6-8), concomitant MTX 48.8 %, concomitant PSL 67.5 %, previous use of biologics 67.9 %.  Remission rate (DAS28) at 52 weeks in our study was 42.9 %. Patients with concomitant GC at baseline had significant higher disease activity (DAS28; 5.8 vs 5.3, p=0.01) and rate of previous biologics use (74.1 % vs 55.1 %, p=0.003), and marginally higher rate of concomitant MTX (53.1% vs 39.7%, p=0.053), compared to patients with no concomitant GC, respectively. The multivariate logistic regression analysis showed predictive factors for remission in patients with high DAS28(≥5.6) at week 52 were follows: no previous use of biologics [OR3.15 (1.20-8.58)], and concomitant MTX [OR3.04(1.23-8.03)] and no concomitant GC[OR3.48 (1.36-9.29)]. Interestingly, that in the patients with low DAS28(<5.6) was only no concomitant GC [OR2.81 (1.21-6.82)].  MTX plays critical roles on RA treatment. However, approximately one-third of RA patients receive monotherapy without MTX due to MTX-induced adverse events. Therefore, the information with treatment background of limited dose of MTX should be important for clinical practice. Decision of prolonged concomitant GC was based on physicians’ clinical observation during treatment before initiation of TCZ. This bias could be critical predictive factor not to achieve better outcome. 

Conclusion: Remission rate at week 52 in TCZ treatment was predictable by baseline factors in daily practice. In patients with high disease activity, concomitant MTX could be important for achievement of remission with TCZ. Physicians’ decision for concomitant use of GC in practice was strongly associated with not-achievement of remission during TCZ treatment with background of limited dose of MTX.

---

« Back to 2013 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/relationship-between-physicians-decision-to-use-concomitant-glucocorticoid-and-remission-during-treatment-with-tocilizumab-in-patients-with-background-of-limited-dose-of-mtx/