Background/Purpose: Since 2003 in Japan, biologic agents have become widely used for RA patients in whom csDMARDs were ineffective. Tocilizumab (TCZ) was approved for marketing for use in patients with RA in Japan ahead of other countries in 2008. Randomized controlled trials have been shown the efficacy and safety of TCZ in patients with RA. Infliximab (IFX) is the first approved TNF inhibitor in Japan and it has abundant evidences for RA treatment. There have been few reports about the head to head comparison between IL-6 inhibitor and TNF inhibitors in patients with RA. We investigated the efficacy, safety, and adherence in RA patients treated with TCZ or IFX in real clinical practice.

Methods: One hundred sixty-one patients with RA treated with TCZ or IFX were retrospectively observed for 12 months in Saitama Medical University Hospital since 2008 to 2016. We compared the baseline characteristics, disease activity, physical disability, drug continuation rate, and adverse events between the patients treated with TCZ or IFX.

Results: In TCZ group (n=89) compared with IFX group (n=72), we found longer disease duration (TCZ vs. IFX: 9.8 vs. 6.4years p=0.001), lower rate of biologic-naïve patients (27.0% vs. 94.4% p<0.001), fewer MTX-users (66.3% vs. 100% p<0.001), and lower dose of MTX (5.8 vs. 8.5mg/week p<0.001). Age of disease onset, rate of female, DAS28-ESR4, HAQ-DI, RF, MMP-3, and daily dose of PSL were similar between the groups. DAS28-ESR4 and HAQ-DI significantly decreased for one year in both groups. The patients who achieved remission or low disease activity in CDAI were more in TCZ group than IFX group (83.8% vs. 62.5% p=0.016). There was no significant difference in the drug continuation rate (80.9% vs. 75.0%). In the patients who discontinued TCZ or IFX during one year of observational period, the rate of adverse events or lack of efficacy was not significantly different between the groups. We also investigated the efficacy, safety and drug continuation rate of TCZ (n=24) or IFX (n=68) as a first biologic for RA. The prevalence of patients who achieved remission or low disease activity in CDAI were more in TCZ group than IFX group (95.0% vs. 61.7% p=0.007), and there was no significant difference in the drug continuation rate (83.3% vs. 77.9%). The rate in lack of efficacy was lower in TCZ group than IFX group (0% vs. 10.3%) and there was no difference in adverse events between the groups (16.7% vs. 11.8%).

Conclusion: TCZ-treated patients, who, despite, had longer disease duration, were less biologic-naïve, and fewer MTX-users, showed equivalent or greater efficacy, drug continuation rate, and safety comparing with those treated with IFX.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/the-comparative-observational-study-about-efficacy-safety-and-adherence-between-tocilizumab-and-infliximab-in-patients-with-rheumatoid-arthritis/