Predictive factors for achievement of mucosal healing by budesonide 2-mg foam in ulcerative colitis: a pooled analysis of data from two clinical trials
| Autor: | Mamoru Watanabe, Yoshitomo Chujoh, Toshifumi Hibi, Ryoichi Yoshihara, Eisei Oda, Yoji Yamada, Makoto Naganuma |
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| Rok vydání: | 2020 |
| Předmět: |
Budesonide
medicine.medical_specialty medicine.medical_treatment lcsh:Medicine Suppository Gastroenterology 03 medical and health sciences 0302 clinical medicine Internal medicine complete mucosal healing Post-hoc analysis medicine lcsh:RC799-869 Colitis colitis ulcerative budesonide foam business.industry lcsh:R Enema Inflammatory Bowel Diseases medicine.disease Ulcerative colitis Clinical trial 030220 oncology & carcinogenesis Mucosal healing Original Article lcsh:Diseases of the digestive system. Gastroenterology 030211 gastroenterology & hepatology business medicine.drug |
| Zdroj: | Intestinal Research, Vol 18, Iss 1, Pp 56-68 (2020) Intestinal Research |
| ISSN: | 2288-1956 1598-9100 |
| Popis: | Background/Aims: Mucosal healing (MH) of distal lesions in ulcerative colitis (UC) has recently been confirmed with budesonide 2-mg foam (BF) treatment in 2 clinical trials; however, few studies have investigated the predictive factors for complete MH. Methods: We conducted a post hoc analysis using pooled data from phase II and III clinical trials evaluating the efficacy and safety of BF for UC. Additionally, we analyzed the relationships between complete MH and baseline factors and clinical symptoms from baseline to week 6. Results: Among the 291 Japanese patients from the 2 pooled clinical studies, 119 patients in the BF twice a day group and 117 in the placebo group were included in the full analysis set. The proportion of patients with a rectal bleeding (RB) subscore of 0 was significantly higher in the BF group than in the placebo group after a 5-day treatment (P |
| Databáze: | OpenAIRE |
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