1.Efficacy of biologic therapies for biologic-naïve Japanese patients with moderately to severely active ulcerative colitis: a network meta-analysis
Toshifumi HIBI ; Isao KAMAE ; Philippe PINTON ; Lyann URSOS ; Ryuichi IWAKIRI ; Greg HATHER ; Haridarshan PATEL
Intestinal Research 2021;19(1):53-61
Background/Aims:
Several biologic therapies are approved in Japan to treat moderately to severely active ulcerative colitis (UC), but there are no published comparative efficacy studies in a Japanese population. We compared the efficacy of biologics approved in Japan (adalimumab, infliximab, golimumab, and vedolizumab) for treating biologic-naïve patients with UC at their approved doses.
Methods:
A targeted literature review identified 4 randomized controlled trials of biologics for UC in biologicnaïve Japanese patients. For each study, efficacy outcome data from induction (weeks 6–12) and maintenance (weeks 30–60) treatment were extracted for analysis. Treatment effects on clinical response, clinical remission, and mucosal healing relative to the average placebo results across all trials were estimated using network meta-analyses followed by transformation into probabilities and odds ratios (OR).
Results:
At the end of induction, the likelihood of clinical response and clinical remission was highest with infliximab (OR: 2.12 and 2.35, respectively) and vedolizumab (OR: 2.10 and 2.32, respectively); the likelihood of mucosal healing was highest with infliximab (OR: 2.24) and adalimumab (OR: 1.86). During maintenance, the likelihood of clinical response and clinical remission was highest with vedolizumab (OR: 6.44 and 4.68, respectively) and golimumab (OR: 5.13 and 3.84, respectively); the likelihood of mucosal healing was significantly higher than placebo with all biologics.
Conclusions
All active treatments were efficacious compared with placebo. Infliximab and vedolizumab had the highest odds for induction of clinical response, remission, and mucosal healing. Golimumab and vedolizumab had numerically higher odds of achieving efficacy outcomes in the maintenance phase.
2.Upper Gastrointestinal Symptoms Are More Frequent in Female than Male Young Healthy Japanese Volunteers as Evaluated by Questionnaire.
Hiroharu KAWAKUBO ; Yuichiro TANAKA ; Nanae TSURUOKA ; Megumi HARA ; Koji YAMAMOTO ; Hidenori HIDAKA ; Yasuhisa SAKATA ; Ryo SHIMODA ; Ryuichi IWAKIRI ; Motoyasu KUSANO ; Kazuma FUJIMOTO
Journal of Neurogastroenterology and Motility 2016;22(2):248-253
BACKGROUND/AIMS: Upper gastrointestinal symptoms are more frequent and severe in female than in male outpatients in Japan. This study compared the upper gastrointestinal symptoms between healthy male and female young adult volunteers using a questionnaire. METHODS: In total, 581 third-grade medical students at Saga Medical School aged 22 to 30 years underwent upper gastrointestinal endoscopy and completed a questionnaire (frequency scale for symptoms of gastroesophageal reflux disease) from 2007 to 2013. Of these 581 students, 298 who were negative for Helicobacter pylori infection and had no particular lesions on endoscopic examination were enrolled in the present evaluation. A symptom was defined as positive when the subject evaluated the frequency of the symptom as sometimes, often, or always. RESULTS: The subjects comprised of 163 males (average age, 23.7 years) and 135 females (average age, 23.1 years). Upper gastrointestinal symptoms were more frequent in the females (75 of 135, 55.6%) than males (69 of 163, 42.3%; P < 0.05), with a high score for 4 symptoms (bloated stomach, heavy feeling in the stomach after meals, subconscious rubbing of the chest with the hand, and feeling of fullness while eating meals). Of the 144 subjects (69 males and 75 females) who complained of these symptoms, the females complained of dysmotility symptoms more often than did the males, but this was not true for reflux symptoms. CONCLUSIONS: This study suggests that females develop upper gastrointestinal symptoms more frequently than do males among the young healthy Japanese population.
Asian Continental Ancestry Group*
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Dyspepsia
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Eating
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Endoscopy
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Endoscopy, Gastrointestinal
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Esophagitis
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Female*
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Gastroesophageal Reflux
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Gastrointestinal Motility
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Hand
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Helicobacter pylori
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Humans
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Japan
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Male*
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Meals
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Outpatients
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Schools, Medical
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Stomach
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Students, Medical
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Thorax
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Unconscious (Psychology)
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Volunteers*
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Young Adult