Publications by authors named "Tetsuji Kitawaki"
Objectives: To assess the efficacy and safety of canakinumab in Japanese patients with systemic juvenile idiopathic arthritis (sJIA).
Methods: This was an open-label, single-arm active treatment study. sJIA patients, aged ≥2 to <20 years, were administered canakinumab 4 mg/kg every 4 weeks for ≤48 weeks.
Background: To better evaluate the efficacy and safety of the indacaterol/glycopyrronium (IND/GLY) fixed-dose combination versus tiotropium in Japanese patients, a pooled data analysis was conducted from the SHINE and ARISE studies, which were part of the IND/GLY clinical trial program.
Methods: Japanese patients with moderate-to-severe COPD were included in the analysis. Efficacy in terms of pre-dose forced expiratory volume in one second (FEV) at Week 12 and Week 24/26 (ARISE/SHINE) and FEV at 30min and 60min post-dose at Day 1, Week 12, and Week 24/26 was evaluated.
Background: COPD-related deaths are increasing in Japan, with ~5.3 million people at risk.
Methods: The SHINE was a 26-week, multicenter, randomized, double-blind, parallel-group study that evaluated safety and efficacy of indacaterol (IND)/glycopyrronium (GLY) 110/50 μg once daily (od) compared with GLY 50 μg od, IND 150 μg od, open-label tiotropium (TIO) 18 μg od, and placebo.
Introduction: This post hoc analysis evaluated the efficacy of indacaterol, a novel inhaled once-daily long-acting β(2)-agonist, by disease severity (GOLD 2005) in patients with moderate-to-severe COPD from six Asian countries/areas (Hong Kong, India, Japan, Korea, Singapore, Taiwan).
Methods: Data from a 12-week, double-blind, placebo-controlled, parallel-group study in patients randomized to indacaterol 150 μg, indacaterol 300 μg or placebo once daily were analyzed based on baseline disease severity (moderate or severe). Endpoints were: trough FEV(1) (average of 23 h 10 min and 23 h 45 min post-dose values), transition dyspnoea index (TDI) and St George's Respiratory Questionnaire (SGRQ) at Week 12.