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Efficacy and safety of subcutaneous tocilizumab in rheumatoid arthritis over 1 year: a UK real-world, open-label study

Isaacs, John D, Salih, Abdelrazig, Sheeran, Thomas, Patel, Yusuf I, Douglas, Karen, McKay, Neil D, Naisbett-Groet, Barbara and Choy, Ernest 2019. Efficacy and safety of subcutaneous tocilizumab in rheumatoid arthritis over 1 year: a UK real-world, open-label study. Rheumatology Advances in Practice 3 (1) , -. 10.1093/rap/rkz010

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Abstract

Objective. The ACT-MOVE study assessed the real-world efficacy and safety of s.c. tocilizumab (TCZSC), provided as monotherapy or in combination with conventional synthetic DMARDs (csDMARDs) over 1 year, in patients with RA and an inadequate response to csDMARD therapy and/or first TNF inhibitor. Methods. In this UK multicentre, open-label phase IIIb study, patients received TCZ-SC 162 mg once weekly for 52 weeks as monotherapy or with csDMARDs. Efficacy and safety were evaluated at baseline, weeks 2 and 4 and every 4 weeks thereafter up to week 52. Results. Of 161 patients who received at least one dose of TCZ-SC, 21 (13.0%) received TCZ-SC alone and 140 (87.0%) TCZ-SC with a csDMARD(s). From baseline to week 52, there was a mean decrease in DAS28-ESR score among all patients (!3.68), and within monotherapy (!3.75) and combination therapy (!3.67) groups. The proportion of patients who achieved DAS28 clinical remission (DAS28-ESR <2.6) at week 52 was 75.4% (95% CI 66.8, 82.8). At the same time point, "80% of patients who remained on TCZ-SC achieved DAS28 clinical remission or had low disease activity (DAS28-ESR "2.6 and #3.2). Overall, 6.2% of patients had at least one serious adverse event (10.2/ 100 patient-years), and there was one death; 11.2% of patients discontinued owing to adverse events. Conclusion. TCZ-SC was effective and tolerated in a real-world setting over 1 year. The efficacy of TCZ-SC was similar whether given as monotherapy or with csDMARDs; its safety profile was consistent with that previously established

Item Type: Article
Date Type: Published Online
Status: Published
Schools: Medicine
ISSN: 2514-1775
Date of First Compliant Deposit: 3 October 2019
Date of Acceptance: 31 March 2019
Last Modified: 04 Oct 2019 14:45
URI: http://orca.cf.ac.uk/id/eprint/125856

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