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Observational Study
. 2018 Apr;38(4):579-587.
doi: 10.1007/s00296-017-3870-7. Epub 2017 Nov 16.

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

Lisa Baganz  1 , Adrian Richter  2 , Jörn Kekow  3 , Arnold Bussmann  4 , Andreas Krause  5 , Carsten Stille  6 , Joachim Listing  2 , Angela Zink  7 , Anja Strangfeld  2
Affiliations
Observational Study

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

Lisa Baganz et al. Rheumatol Int. 2018 Apr.

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.

Keywords: Biologics register; IL-6 blockade; Line of therapy; Observational cohort study; Treatment strategy.

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Conflict of interest statement

Ethical approval

The study protocol of RABBIT was approved by the ethics committee of the Charité University Medicine Berlin (reference number: 1508/2001). Prior to enrolment, all patients have to give their informed consent.

Conflict of interest

Lisa Baganz: No competing interest. Adrian Richter: Honoraria from Pfizer outside the submitted work. Jörn Kekow: No competing interests. Arnold Bussmann: No competing interests. Andreas Krause: Grants and personal fees from Roche/Chugai outside the submitted work. Carsten Stille: No competing interests. Joachim Listing: No competing interests. Angela Zink: Grants and personal fees from AbbVie, BMS, MSD, Pfizer, Roche, and UCB outside the submitted work. Anja Strangfeld: Personal fees from AbbVie, BMS, MSD, Pfizer, Roche, Sanofi-Aventis and UCB outside the submitted work.

Funding

The German Biologics Register RABBIT is supported by a joint, unconditional Grant from AbbVie, Bristol-Myers Squibb, MSD Sharp & Dohme, Pfizer, Roche, and UCB.

Figures

Fig. 1
Fig. 1
Kaplan–Meier curves for retention of tocilizumab therapy over 3 years. The patients were stratified by the number of prior bDMARD failures. The numbers on top of the x-axis represent the number of patients at risk at the corresponding time point
Fig. 2
Fig. 2
Time-varying percentage of patients who received either no concomitant glucocorticoids, > 0–5, > 5–10  or > 10 mg/d. Missing glucocorticoid doses and doses of patients who switched to another biologic where imputed using LOCF
See this image and copyright information in PMC

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