Abstract
ObjectiveThe 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.MethodsIn 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.ResultsOf 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.ConclusionTCZ-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 registrationClinicalTrials.gov, http://www.clinicaltrials.gov, NCT02046603.
Highlights
RA is an autoimmune disease affecting $1% of the global population that is associated with painful inflammation and destruction of the joints and surrounding tissue [1]
From baseline to week 52, there was a mean decrease in DAS using 28 joints (DAS28)-ESR score among all patients (À3.68), and within monotherapy (À3.75) and combination therapy (À3.67) groups
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)
Summary
RA is an autoimmune disease affecting $1% of the global population that is associated with painful inflammation and destruction of the joints and surrounding tissue [1]. In Europe, recommended treatment involves early initiation of conventional synthetic DMARDs (csDMARDs) and, if an adequate response is not achieved, addition of a biological therapy, such as tocilizumab (TCZ), abatacept or a TNF inhibitor, or a targeted synthetic DMARD (i.e. a Janus kinase inhibitor) [2]. TCZ was initially approved as an i.v. formulation (TCZ-IV) for treatment of patients with moderate-to-severe active RA and an inadequate response or intolerance to previous csDMARDs or anti-TNF therapy. Data from several phase III trials demonstrated the efficacy and safety of TCZ-IV alone and with csDMARD therapy in this patient population [5,6,7,8,9]. Longer-term data from the LITHE trial showed that the efficacy and safety of TCZ-IV were maintained for up to 5 years [10]
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