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

John D Isaacs, Abdelrazig Salih, Thomas Sheeran, Yusuf I Patel, Karen Douglas, Neil D McKay, Barbara Naisbett-Groet, Ernest Choy, John D Isaacs, Abdelrazig Salih, Thomas Sheeran, Yusuf I Patel, Karen Douglas, Neil D McKay, Barbara Naisbett-Groet, Ernest Choy

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.

Keywords: United Kingdom; biological therapies; conventional synthetic DMARDs; real world; rheumatoid arthritis; subcutaneous; tocilizumab.

Figures

Fig . 1
Fig. 1
Mean DAS28-ESR (A), clinical disease activity index (B) and simplified disease activity index (C) scores over 52 weeks (full analysis set) BL: baseline; CDAI: clinical disease activity index; DAS28: DAS for 28 joints; SDAI: simplified disease activity index.
Fig . 2
Fig. 2
DAS28-ESR, clinical disease activity index and simplified disease activity index disease activity at week 52 (full analysis set) Data are shown as a percentage of the patients in each group at baseline (all patients, n = 161; monotherapy, n = 21; combination therapy, n = 140). As a result of patients withdrawing from the study, the percentages at week 52 do not total 100. CDAI: clinical disease activity index; DAS28: DAS for 28 joints; SDAI: simplified disease activity index.
Fig . 3
Fig. 3
ACR and EULAR responses at week 52 (full analysis set) Data are shown as a percentage of the patients in each group at baseline (all patients, n = 161; monotherapy, n = 21; combination therapy, n = 140). As a result of patients withdrawing from the study, the percentages at week 52 do not total 100.
Fig . 4
Fig. 4
Mean change in select patient-reported outcome assessment scores over time (weeks 1–52; full analysis set) (A) VAS scores for patient global assessment of disease activity. (B) VAS score for patient assessment of RA-related pain. (C) HAQ-DI scores. (D) FACIT-F scores. BL: baseline; DI: disability index; FACIT-F: functional assessment of chronic illness therapy – fatigue; PRO: patient-reported outcome; VAS: visual analog scale.

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