Long-term efficacy and safety of tocilizumab in refractory Takayasu arteritis: final results of the randomized controlled phase 3 TAKT study.

ABSTRACT: OBJECTIVE:To investigate the long-term efficacy and safety of the IL-6 receptor antibody tocilizumab in patients with Takayasu arteritis (TAK). METHODS:Patients completing the randomized, double-blind, placebo-controlled period of the TAKT (Takayasu arteritis Treated with Tocilizumab) trial were followed up during open-label extended treatment with weekly s.c. tocilizumab 162?mg for up to 96?weeks or longer, with oral glucocorticoid tapering performed at the investigators' discretion. Endpoints of the extension analysis included steroid-sparing effects of tocilizumab, imaging data, patient-reported outcomes (36-Item Short Form Health Survey) and safety. RESULTS:All 36 patients enrolled in the double-blind period entered the open-label extension; 28 patients received tocilizumab for 96?weeks. The median glucocorticoid dose was 0.223?mg/kg/day at the time of relapse before study entry, 0.131?mg/kg/day (interquartile range 0.099, 0.207) after 48?weeks and 0.105?mg/kg/day (interquartile range 0.039, 0.153) after 96?weeks. Overall, 46.4% of patients reduced their dose to <0.1?mg/kg/day, which was less than half the dose administered at relapse before study entry (mean difference -0.120?mg/kg/day; 95% CI -0.154, -0.087). Imaging evaluations indicated that most patients' disease was improved (17.9%) or stable (67.9%) after 96?weeks compared with baseline. Mean 36-Item Short Form Health Survey physical and mental component summary scores and 7 of 8 domain scores were clinically improved from baseline and maintained over 96?weeks of tocilizumab treatment. No unexpected safety issues were reported. CONCLUSION:These results in patients with Takayasu arteritis provide evidence of a steroid-sparing effect and improvements in well-being during long-term treatment with once-weekly tocilizumab 162?mg, with no new safety concerns. TRIAL REGISTRATION:JAPIC Clinical Trials Information, http://www.clinicaltrials.jp/user/cteSearch_e.jsp, JapicCTI-142616.

SUBMITTER: Nakaoka Y 

PROVIDER: S-EPMC7449811 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature