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Tocilizumab in treatment-naive patients with Takayasu arteritis: TOCITAKA French prospective multicenter open-labeled trial.

ABSTRACT: OBJECTIVES:To assess long-term efficacy of tocilizumab in treatment-naive patients with Takayasu arteritis (TAK). METHODS:Prospective open-labeled trial in naïve patients with TAK who received steroids at the dose of 0.7?mg/kg/day and 7 infusions of 8?mg/kg/month of tocilizumab. The primary endpoint was the number of patients who discontinued steroids after 7 infusions of tocilizumab. Secondary endpoints included disease activity and the number of relapses during 18-month follow-up. RESULTS:Thirteen patients with TAK were included, with a median age of 32?years [19-45] and 12 (92%) females. Six (54%) patients met the primary end-point. A significant decrease of disease activity was observed after 6?months of tocilizumab therapy: decrease of median NIH scale (3 [3, 4] at baseline, versus 1 [0-2] after 6?months; p?

SUBMITTER: Mekinian A

PROVIDER: S-EPMC7500024 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Tocilizumab in treatment-naïve patients with Takayasu arteritis: TOCITAKA French prospective multicenter open-labeled trial.

Mekinian Arsene A Saadoun David D Vicaut Eric E Thietart Sara S Lioger Bertrand B Jego Patrick P Bleibtreu Alexandre A Limal Nicolas N Connault Jerome J Gottenberg Jacques-Eric JE Lhorte Pauline P Bertola Jean Pierre JP Delforge Juliette J Ferreira-Maldent Nicole N Perlat Antoinette A Talib Zohra Z Vautier Matthieu M Savey Léa L Quiere Isabelle I Cacoub Patrice P Fain Olivier O

Arthritis research & therapy 20200917 1

<h4>Objectives</h4>To assess long-term efficacy of tocilizumab in treatment-naive patients with Takayasu arteritis (TAK).<h4>Methods</h4>Prospective open-labeled trial in naïve patients with TAK who received steroids at the dose of 0.7 mg/kg/day and 7 infusions of 8 mg/kg/month of tocilizumab. The primary endpoint was the number of patients who discontinued steroids after 7 infusions of tocilizumab. Secondary endpoints included disease activity and the number of relapses during 18-month follow-u ...[more]

PMID: 32943098

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Project description:ObjectiveTo investigate the long-term efficacy and safety of the IL-6 receptor antibody tocilizumab in patients with Takayasu arteritis (TAK).MethodsPatients 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.ResultsAll 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.ConclusionThese 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 registrationJAPIC Clinical Trials Information, http://www.clinicaltrials.jp/user/cteSearch_e.jsp, JapicCTI-142616.

Dataset Information

Tocilizumab in treatment-naive patients with Takayasu arteritis: TOCITAKA French prospective multicenter open-labeled trial.

Publications

Tocilizumab in treatment-naïve patients with Takayasu arteritis: TOCITAKA French prospective multicenter open-labeled trial.

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