دورية أكاديمية
Efficacy and safety of ustekinumab in East Asian patients with moderately to severely active ulcerative colitis: a subpopulation analysis of global phase 3 induction and maintenance studies (UNIFI)
| العنوان: | Efficacy and safety of ustekinumab in East Asian patients with moderately to severely active ulcerative colitis: a subpopulation analysis of global phase 3 induction and maintenance studies (UNIFI) |
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| المؤلفون: | Tadakazu Hisamatsu, Hyo Jong Kim, Satoshi Motoya, Yasuo Suzuki, Yoshifumi Ohnishi, Noriyuki Fujii, Nobuko Matsushima, Richuan Zheng, Colleen W. Marano |
| المصدر: | Intestinal Research, Vol 19, Iss 4, Pp 386-397 (2021) |
| بيانات النشر: | Korean Association for the Study of Intestinal Diseases, 2021. |
| سنة النشر: | 2021 |
| المجموعة: | LCC:Medicine LCC:Diseases of the digestive system. Gastroenterology |
| مصطلحات موضوعية: | east-asian, ulcerative colitis, subgroup analysis, unifi, ustekinumab, Medicine, Diseases of the digestive system. Gastroenterology, RC799-869 |
| الوصف: | Background/Aims We aimed to evaluate the efficacy and safety of ustekinumab (UST) in the East-Asian population with moderate to severely active ulcerative colitis (UC). Methods This sub-analysis was conducted on data from East-Asian patients included in the UNIFI program (NCT02407236). UNIFI consisted of two double-blind, placebo-controlled trials: an 8-week induction study and a 44-week randomized withdrawal maintenance study. Results Of 133 East-Asian patients (Japanese: 107, Korean: 26) who underwent randomization, 131 completed induction study and 111 entered maintenance study. In the maintenance study, 78 patients were randomized. Patients who received UST 130 mg and UST 6 mg/kg showed numerically higher clinical remission at week 8 in the induction study (5/44 [11.4%] and 5/45 [11.1%], respectively) compared with those who received placebo (0/44, 0%). The proportion of patients achieved clinical remission at week 44 was numerically higher in the UST 90 mg q12w group (10/21, 47.6%), but similar in the UST 90 mg q8w group (5/26, 19.2%) compared to placebo (7/31, 22.6%). Serious adverse events were reported in 1 patient in UST 130 mg group, but no patient in UST 6 mg/kg group through week 8 in the induction study, and 1 patient in UST 90 mg q12w group and 5 patients in the UST 90 mg q8w group in the maintenance study. No deaths were reported in East-Asian patients throughout the study. Conclusions UST induction and maintenance treatments were effective in East-Asian patients with moderate to severe UC; the efficacy and safety profiles were consistent with the overall population. |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 1598-9100 2288-1956 |
| Relation: | http://www.irjournal.org/upload/pdf/ir-2020-00080.pdf; https://doaj.org/toc/1598-9100; https://doaj.org/toc/2288-1956 |
| DOI: | 10.5217/ir.2020.00080 |
| URL الوصول: | https://doaj.org/article/b96b4fbd42fc415799ac18aa0977d1fa |
| رقم الأكسشن: | edsdoj.b96b4fbd42fc415799ac18aa0977d1fa |
| قاعدة البيانات: | Directory of Open Access Journals |
Full Text Finder | تدمد: | 15989100 22881956 |
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| DOI: | 10.5217/ir.2020.00080 |