Abstract
Aim: This study examined the real-world effectiveness and safety outcomes of vedolizumab in ulcerative colitis (UC) patients who had failed anti-tumor necrosis factor (anti-TNF) therapy in Korea. Methods: A retrospective chart review study was conducted in adults with moderate to severely active UC who had failed anti-TNF agents and subsequently received vedolizumab. Clinical response and clinical remission at week 6 and 14 after vedolizumab initiation was evaluated. Safety outcomes were also reported. Outcome rates were compared with a matched sub-cohort derived from the open-label sub-cohort of the GEMINI 1 trial using the optimal matching method. Results: A total of 105 patients (mean age, 45.3 years; 63.8% male) were included. At week 6, 55.8% (n = 43/77) achieved a clinical response and 18.2% (n = 14/77) achieved clinical remission. At week 14, 73.2% (n = 52/71) achieved a clinical response and 39.4% (n = 28/71) achieved clinical remission. When non-response imputation was used, the clinical response rate at week 6 and week 14 were 40.1% (n = 43/105) and 49.5% (n = 52/105) respectively. Of the 105 patients, 16 (15.2%) experienced at least one adverse event. The matched analysis showed that the clinical response rate at week 6 was higher in the matched sub-cohort of this study (24/47, 51.1%) versus the matched sub-cohort from the GEMINI 1 open-label cohort (12/47, 34.3%, p = 0.019). The clinical remission rates at week 6 were similar (7/47, 14.9% versus 9/47, 19.1%, p = 0.785). Conclusions: In the real-world setting, vedolizumab is effective and well tolerated within the first 14 weeks of use in Korea. The proportion of patients experiencing clinical response and clinical remission at 6 and 14 weeks appeared to be largely consistent with that observed in real-world studies from other regions and populations.
| Original language | English |
|---|---|
| Journal | Therapeutic Advances in Gastroenterology |
| Volume | 14 |
| DOIs | |
| Publication status | Published - 2021 |
Bibliographical note
Funding Information:BDY reported receiving research grants from Celltrion, Inc. and Pfizer Korea, and lecture and/or consulting fees from Abbvie Korea, Daewoong Pharma., Ferring Korea, Janssen Korea, Kangstem Biotech, LG Chem., Shire Korea, Takeda Korea, IQVIA, Takeda, Celltrion, Inc., Chong Kun Dang Pharm., Medtronic Korea, and Pfizer Korea, outside of the submitted work. KHS reported receiving lecture fees from Eisai Korea, Celltrion, Inc., and Janssen Korea, outside the submitted work. YHK reported receiving personal fees from Takeda outside the submitted work. KML reported receiving lecture and/or consulting fees from Jassen, Takeda, and Celtrion, outside the submitted work. DWL is an employee of Takeda Korea at the time of this manuscript writing. CYF is an employee of IQVIA Real World Insights at the time of this manuscript writing. IQVIA has supported Takeda and all the clinician investigators in the design, execution, data management and the development of this manuscript. All other co-authors have nothing to disclose.
Funding Information:
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was funded by Takeda Pharmaceuticals Korea (Takeda Korea).
Funding Information:
All co-authors have participated in the conception and design of the study; all clinician investigators collected the data with the support from IQVIA and Takeda; CYF analyzed the study data, and all co-authors interpreted the results. CYF wrote the first draft of this manuscript; all authors critically reviewed the content and approved the final version. The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was funded by Takeda Pharmaceuticals Korea (Takeda Korea).
Publisher Copyright:
© The Author(s), 2021.
All Science Journal Classification (ASJC) codes
- Gastroenterology