Long-term effectiveness of tocilizumab in patients with rheumatoid arthritis, stratified by number of previous treatment failures with biologic agents: results from the German RABBIT cohort

Abstract

In Germany, Tocilizumab (TCZ) is used for the treatment of rheumatoid arthritis both in biologic-naïve patients and those with previous failures of biologic disease-modifying antirheumatic drugs (bDMARDs). The long-term effectiveness and retention rates of TCZ in patients with different numbers of prior bDMARD failures has rarely been investigated. We included 885 RA patients in the analyses, enrolled with the start of TCZ between 2009 and 2015 in the German biologics register RABBIT. Patients were stratified according to prior bDMARD failures: no prior bDMARD or 1, 2 or ≥ 3 bDMARD failures. We applied Kaplan–Meier methods and Cox-regression to examine treatment adherence as well as linear mixed effects models to investigate effectiveness over 3 years of follow-up. Compared to biologic-naïve patients, those with prior bDMARD failures at start of TCZ were younger but had significantly longer disease duration and more comorbidities. DAS28 at baseline and loss of physical function were highest in patients with ≥ 3 bDMARD failures. During follow-up, patients with up to two bDMARD failures on average reached low disease activity (LDA, DAS28 < 3.2). Those with ≥ 3 prior bDMARDs had a slightly lower response. However, after 3 years, nearly 50% of them achieved LDA. Treatment continuation on TCZ therapy was similar in patients with ≤ 2 bDMARD failures but significantly lower in those with ≥ 3 bDMARD failures. TCZ seems to be similarly effective in patients with no, one or two prior bDMARD failures. The majority of patients achieved LDA already after 6 months and maintained it over a period of 3 years. TCZ proved effective even in the high-risk group of patients with more than two prior bDMARD failures.

Individual therapeutic DAS28-dcrit responses differentiate between effectiveness of rheumatoid arthritis therapies and reflect patient-reported outcomes: retrospective analysis of DAS28 responses in comparative tocilizumab studies

“…For both response measures, tocilizumab responses showed greater stability over time than responses to TNF inhibitors, suggesting that therapeutic responses to tocilizumab may be better maintained than therapeutic responses to anti-TNF agents. These findings are consistent with other reports of the long-term effectiveness of tocilizumab [10,11,13,18].…”

Tocilizumab Patterns of Use, Effectiveness, and Safety in Patients with Rheumatoid Arthritis: Final Results from a Set of Multi-National Non-Interventional Studies

“…In addition, patients in the present analysis with any change in corticosteroid dose had an overall reduction in daily dose from baseline to month 6 [mean (SD) change,  − 2.2 (9.0) mg]. Corticosteroid-sparing effects of TCZ have similarly been observed in other real-world studies of TCZ use in routine practice conducted in Japan [9], France [25, 26], Australia [27], Germany [28], and the USA [29]. Together, these findings show that both TCZ monotherapy and combination therapy reduce the need for corticosteroids in patients with RA.…”

Investigating sirukumab for rheumatoid arthritis: 2-year results from the phase III SIRROUND-D study

“…Results demonstrated clinical improvements in patients with up to two previous DMARD failures, with favourable results observed by 6 months of treatment, which endured beyond 3 years. 15 Another anti-IL-6 agent, sarilumab, was demonstrated to achieve clinical success in patients with RA over the course of 1 year of treatment; however, long-term studies are needed to evaluate the durability of those effects. 16 …”