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Observational Study
. 2017 Feb;36(2):241-250.
doi: 10.1007/s10067-016-3485-5. Epub 2016 Dec 2.

Use and effectiveness of tocilizumab among patients with rheumatoid arthritis: an observational study from the British Society for Rheumatology Biologics Register for rheumatoid arthritis

Mari Kihara  1   2 , Rebecca Davies  1 , Lianne Kearsley-Fleet  1 , Kath D Watson  1 , Mark Lunt  1 , Deborah P M Symmons  1   3 , Kimme L Hyrich  4   5 ; British Society for Rheumatology Biologics Register
Affiliations
Observational Study

Use and effectiveness of tocilizumab among patients with rheumatoid arthritis: an observational study from the British Society for Rheumatology Biologics Register for rheumatoid arthritis

Mari Kihara et al. Clin Rheumatol. 2017 Feb.

Abstract

The aims of the present study are to describe the characteristics of rheumatoid arthritis (RA) patients selected for tocilizumab (TCZ), compare the "real-world" effectiveness of TCZ and tumour necrosis factor inhibitors (TNFi) when used as a first biologic and assess the influence of past biologic exposure/concurrent methotrexate (MTX) therapy on post-TCZ treatment outcomes. The British Society for Rheumatology Biologics Register (BSRBR-RA) is a prospective cohort study following RA patients starting biologics in the UK. This includes patients starting TCZ as first or subsequent biologic, alongside biologic-naïve patients starting TNFi. Six-month disease activity and 1-year drug survival were compared between biologic-naïve patients starting TCZ versus TNFi and first-line versus subsequent TCZ users and TCZ users with MTX versus without using regression models adjusted by propensity score. Two hundred seventeen patients started TCZ, and 2419 started TNFi as first biologic. Seven hundred seventy-seven started TCZ after other biologics. First-line TCZ users had a higher prevalence of pulmonary fibrosis and cancer history than TNFi users. The first-line TCZ users were more likely to achieve DAS28 remission at 6 months than first-line TNFi, but other improvement markers were similar. The treatment response at 6 months was similar between subsequent-line TCZ users and first-line users after adjusting for baseline patient differences. Concurrent MTX use was not associated with treatment response in either first- or subsequent-line TCZ users. TCZ has been primarily used as subsequent-line biologic in the UK. When used as first line, the response appears similar to that observed in patients starting TNFi, suggesting that clinical response alone should not decide between initial biologic therapies.

Keywords: Biological disease modifying anti-rheumatic drugs (bDMARDs); Observational study; Rheumatoid arthritis; Tocilizumab; Treatment outcome; Treatment selection.

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Conflict of interest statement

Compliance with ethical standards This study was given a favourable opinion by the North West Multi-Centre Research Ethics Committee in December 2000 (MREC 00/8/53). Written informed consent was obtained from all participants. No additional approvals were needed to undertake this analysis. Conflict of interest The BSRBR-RA is a UK-wide national project to investigate the safety of biologic agents in routine medical practice. This work was supported by the British Society for Rheumatology (BSR), which receives restricted income from UK pharmaceutical companies, presently Abbvie, Celltrion, Hospira, Pfizer, UCB and Roche, and in the past Swedish Orphan Biovitrum and Merck. This income finances a wholly separate contract between the BSR and the University of Manchester. The principal investigators and their team have full academic freedom and are able to work independently of pharmaceutical industry influence. All decisions concerning analyses, interpretation and publication are made autonomously of any industrial contribution. Members of the University of Manchester team, BSR trustees, committee members and staff complete an annual declaration in relation to conflicts of interest. All relevant information regarding serious adverse events outlined in the manuscript has been reported to the appropriate company as per the contractual agreements/standard operating procedures. K.L.H. declares personal fees from Abbvie and grants and personal fees from Pfizer, unrelated to this study. All other coauthors have nothing to declare.

Figures

Fig. 1
Fig. 1
Drug survival curves of the first-line TNFi cohort, the first-line cohort and the subsequent-line TCZ cohort
Fig. 2
Fig. 2
Drug survival curve comparison between the MTX users versus non-users. a Comparison among the first-line TCZ users. b Comparison among the subsequent-line TCZ users
See this image and copyright information in PMC

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