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.
Highlights
With the advent of biologic disease-modifying antirheumatic drugs, the treatment options for the management of rheumatoid arthritis (RA) have improved tremendously
Most of the 885 patients enrolled with TCZ (64.1%) had one or more biologic disease-modifying antirheumatic drugs (bDMARDs) failures (Table 1): 318 (35.9%) were biologic-naïve, 286 (32.3%) had one bDMARD failure, 186 (21.0%) two, and 95 (10.7%) ≥ 3 prior bDMARD failures
Patients with prior bDMARD failures were significantly different from biologic-naïve patients: they were younger, had longer disease duration, more csDMARD failures, more erosive changes and more severe fatigue
Summary
With the advent of biologic disease-modifying antirheumatic drugs (bDMARDs), the treatment options for the management of rheumatoid arthritis (RA) have improved tremendously. If the target cannot be reached within 6 months after initiating treatment, the therapy should be altered by adding conventional synthetic (cs)DMARDs, switching to a bDMARD and between bDMARDs. Expedited therapy decisions involve sequential use of different DMARDs. more recently licensedbDMARDs representing new modes of action are often prescribed as second-, thirdor fourth-line therapies after failure of a tumor necrosis factor α inhibitor (TNFi). More recently licensedbDMARDs representing new modes of action are often prescribed as second-, thirdor fourth-line therapies after failure of a tumor necrosis factor α inhibitor (TNFi) This practice reflects limited longterm data about safety and effectiveness of new drugs rather than evidence of effectiveness after bDMARD failure
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