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

Autor:	Isaacs JD; Arthritis Research UK Experimental Arthritis Treatment Centre, Institute of Cellular Medicine, Newcastle University, Newcastle-upon-Tyne.; Musculoskeletal Unit, Newcastle-upon-Tyne Hospitals NHS Foundation Trust, Newcastle-upon-Tyne., Salih A; Warrington and Halton Hospitals NHS Foundation Trust, Warrington Hospital, Warrington., Sheeran T; Rheumatology Centre, Cannock Chase Hospital, Cannock., Patel YI; Department of Rheumatology, Hull Royal Infirmary, Hull., Douglas K; Department of Rheumatology, Dudley Group NHS Foundation Trust, Dudley., McKay ND; Rheumatic Diseases Unit, Western General Hospital, Edinburgh., Naisbett-Groet B; Roche Products Ltd, Welwyn Garden City., Choy E; CREATE Centre, Division of Infection and Immunity, Cardiff University, Cardiff, UK.
Jazyk:	angličtina
Zdroj:	Rheumatology advances in practice [Rheumatol Adv Pract] 2019 Apr 19; Vol. 3 (1), pp. rkz010. Date of Electronic Publication: 2019 Apr 19 (Print Publication: 2019).
DOI:	10.1093/rap/rkz010
Abstrakt:	Objective: The ACT-MOVE study assessed the real-world efficacy and safety of s.c. tocilizumab (TCZ-SC), 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. Trial Registration: ClinicalTrials.gov, http://www.clinicaltrials.gov, NCT02046603.
Databáze:	MEDLINE
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