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

Author

Isaacs JD1,2, Salih A3, Sheeran T4, Patel YI5, Douglas K6, McKay ND7, Naisbett-Groet B8, Choy E9. Rheumatol Adv Pract. 2019 Apr 19;3(1):rkz010. doi: 10.1093/rap/rkz010. eCollection 2019.

Author Information

1 Arthritis Research UK Experimental Arthritis Treatment Centre, Institute of Cellular Medicine, Newcastle University, Newcastle-upon-Tyne.

2 Musculoskeletal Unit, Newcastle-upon-Tyne Hospitals NHS Foundation Trust, Newcastle-upon-Tyne.

3 Warrington and Halton Hospitals NHS Foundation Trust, Warrington Hospital, Warrington.

4 Rheumatology Centre, Cannock Chase Hospital, Cannock.

5 Department of Rheumatology, Hull Royal Infirmary, Hull.

6 Department of Rheumatology, Dudley Group NHS Foundation Trust, Dudley.

7 Rheumatic Diseases Unit, Western General Hospital, Edinburgh.

8 Roche Products Ltd, Welwyn Garden City.

9 CREATE Centre, Division of Infection and Immunity, Cardiff University, Cardiff, UK.

Abstract

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.