Publications by authors named "Kimitoshi Ikeda"
Introduction: Upadacitinib, an oral, selective Janus kinase inhibitor, is approved in Japan for the treatment of moderate-to-severe atopic dermatitis (AD), a chronic inflammatory skin disease characterized by eczematous morphology and intense itch.
Methods: Rising Up is an ongoing phase 3, randomized, multicenter study evaluating the long-term safety and efficacy of upadacitinib in Japan. Patients with moderate-to-severe AD were randomized 1:1:1 to topical corticosteroids plus upadacitinib 15 mg (UPA15), upadacitinib 30 mg (UPA30), or placebo at baseline; at week 16, placebo patients were rerandomized 1:1 to UPA15 or UPA30 (plus topical corticosteroids per investigator discretion).
Background: Treatment options for adolescents with moderate-to-severe atopic dermatitis (AD) are limited. Oral corticosteroid therapies are used to treat children and adolescents with moderate-to-severe AD; however, long-term use is not recommended because of potential growth impairment. Upadacitinib, an oral Janus kinase inhibitor, is approved to treat moderate-to-severe AD in the United States, Japan, and Europe.
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- The SERENE UC study aimed to assess the effectiveness of higher doses of adalimumab (a medication for ulcerative colitis) in patients with moderate to severe cases.
- This phase 3 trial involved a main study plus a Japan substudy, with participants randomly assigned to either higher or standard dosing regimens for both induction and maintenance phases.
- While the study did not meet its primary endpoints, it indicated a potential benefit with higher maintenance doses, suggesting improved rates of clinical remission while maintaining a similar safety profile to standard dosing.
Background: Systemic atopic dermatitis treatments that have acceptable safety are needed.
Objective: To evaluate the safety of the oral Janus kinase inhibitor upadacitinib in combination with topical corticosteroids (TCSs) for the treatment of atopic dermatitis.
Methods: In this phase 3, double-blind study (Rising Up), Japanese patients (12-75 years) with moderate-to-severe atopic dermatitis were randomized in a 1:1:1 ratio to receive 15 mg of upadacitinib + TCS, 30 mg of upadacitinib + TCS, or a placebo + TCS (rerandomized in a 1:1 ratio to receive either 15 or 30 mg of upadacitinib + TCS at week 16).
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.
In recent years, multi-regional trials have received increasing attention by pharmaceutical companies carrying out global drug development programs. In Japan, new drugs are often approved several years after market release in other countries. The recently published guidance on 'Basic Principles on Global Clinical Trials' addresses specifically this time lag.
View Article and Find Full Text PDFBackground: We have previously demonstrated that addition of omalizumab to standard therapy improved asthma control by significantly improving lung function and reducing asthma exacerbations in Japanese patients with moderate-to-severe asthma. The aim of this study was to evaluate the effects of omalizumab on long-term disease control in Japanese patients with moderate-to-severe persistent asthma.
Methods: An open-label, 48-week study was conducted in 133 Japanese patients with moderate-to-severe persistent asthma.