Ooi, Choon Jin and Hilmi, Ida Normiha and Kim, Hyo-Jong and Jalihal, Umesh and Wu, Deng-Chyang and Demuth, Dirk and Lindner, Dirk and Adsul, Shashi (2021) Efficacy and safety of vedolizumab in ulcerative colitis in patients from Asian countries in the GEMINI 1 study. Intestinal Research, 19 (1). 71+. ISSN 1598-9100, DOI https://doi.org/10.5217/ir.2019.09159.
Full text not available from this repository.Abstract
Background/Aims: The efficacy and safety of vedolizumab in moderate to severely active ulcerative colitis (UC) have been demonstrated in the GEMINI 1 study (NCT00783718). This post-hoc exploratory analysis sought to establish the efficacy and safety of vedolizumab in a subgroup of patients from Asian countries with UC from GEMINI I. Methods: Efficacy outcomes of interest were clinical response, clinical remission and mucosal healing at week 6 (induction phase); and clinical remission, durable clinical response, durable clinical remission, mucosal healing and glucocorticoid-free remission at week 52 (maintenance phase). Differences in outcome rates between vedolizumab and placebo in Asian countries (Hong Kong, India, Malaysia, Singapore, South Korea, and Taiwan) were assessed using descriptive analyses, and efficacy and safety compared between Asian and non Asian countries. Results: During induction, in Asian countries (n = 58), clinical response rates at week 6 with vedolizumab and placebo were 55.2% and 24.1%, respectively (difference 31.0%; 95% confidence interval: 7.2%-54.9%). In non-Asian countries (n=316), response rates at week 6 with vedolizumab and placebo were 45.9% and 25.8%, respectively. During maintenance, in Asian countries, clinical remission rates at 52 weeks with vedolizumab administered every 8 weeks, vedolizumab administered every 4 weeks and placebo were 9.1%, 36.8%, and 31.6%, respectively; corresponding rates for mucosal healing were 45.5%, 47.4%, and 47.4%, respectively. Vedolizumab was well-tolerated; adverse event frequency was comparable in Asian and non-Asian countries. Conclusions: In patients from Asian countries, the efficacy and safety of vedolizumab in treatment of UC were broadly consistent with that in the overall study population.
| Item Type: | Article |
|---|---|
| Funders: | Takeda Pharmaceutical Company Ltd |
| Subjects: | R Medicine > R Medicine (General) |
| Divisions: | Faculty of Medicine > School of Medicine |
| Depositing User: | Ms Zaharah Ramly |
| Date Deposited: | 23 May 2022 01:24 |
| Last Modified: | 23 May 2022 01:24 |
| URI: | http://eprints.um.edu.my/id/eprint/34990 |
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