Intest Res.  2021 Jan;19(1):71-82. 10.5217/ir.2019.09159.

Efficacy and safety of vedolizumab in ulcerative colitis in patients from Asian countries in the GEMINI 1 study

Affiliations
  • 1Duke-NUS Medical School, Gleneagles Medical Centre, Singapore
  • 2University Malaya Medical Centre, Kuala Lumpur, Malaysia
  • 3Kyung Hee University School of Medicine, Seoul, Korea
  • 4M. S. Ramaiah Medical College and Hospital, Bangalore, India
  • 5Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
  • 6Takeda Pharmaceutical International AG, Singapore
  • 7Takeda Pharmaceutical International AG, Zurich, Switzerland

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 1.
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.

Keyword

Vedolizumab; Colitis, ulcerative; Asia; Remission induction; Clinical efficacy

Figure

  • Fig. 1. GEMINI 1 study schematic with number of patients in each treatment arm. In the GEMINI 1 study during the induction phase, the Asian subgroup included 29 patients randomized to vedolizumab (cohort 1) and 29 to placebo. In the Asian subgroup during the maintenance phase, 19 patients were randomized to placebo and 30 patients to the vedolizumab groups.

  • Fig. 2. Comparison of efficacy results for vedolizumab versus placebo in the Asian countries subgroup in GEMINI 1 patients (A) in the induction phase, in the induction intent-to-treat (ITT) population, the rates of clinical response, clinical remission and mucosal healing were numerically higher with vedolizumab compared to placebo, (B) in the maintenance phase, in the maintenance ITT population, the efficacy rates were numerically higher with vedolizumab q4w compared to placebo. Error bars represent 95% confidence intervals. aFor glucocorticoid-free remission, the analysis was restricted to patients who were on glucocorticoids at baseline; therefore the “n” numbers for VDZ q4w, VDZ q8w, and PBO were 9, 6, and 11, respectively. VDZ, vedolizumab; PBO, placebo; q4w, every 4 weeks; q8w, every 8 weeks.

  • Fig. 3. Comparison of efficacy results for vedolizumab versus placebo in the non-Asian countries subgroup in GEMINI 1 patients (A) in the induction phase, in the induction intent-to-treat (ITT) population, the rates of clinical response, clinical remission and mucosal healing were numerically higher with vedolizumab compared to placebo, (B) in the maintenance phase, in the maintenance ITT population, the efficacy rates were higher in both vedolizumab groups compared to placebo for all outcomes. Error bars represent 95% confidence intervals. aFor glucocorticoid-free remission, the analysis was restricted to patients who were on glucocorticoids at baseline; therefore the “n” numbers for VDZ q4w, VDZ q8w and PBO were 64, 64 and 61, respectively. VDZ, vedolizumab; PBO, placebo; q4w, every 4 weeks; q8w, every 8 weeks.

  • Fig. 4. Comparison of efficacy results in the vedolizumab arms of Asian versus non-Asian countries subgroups in GEMINI 1 patients (A) in the induction phase, the rates of clinical response, clinical remission and mucosal healing were numerically higher in the Asian compared to non-Asian subgroup, (B) in the maintenance phase, no clear trend was visible for comparisons between the 2 subgroups. Error bars represent 95% confidence intervals. aFor glucocorticoid-free remission, the analysis was restricted to patients who were on glucocorticoids at baseline; therefore the “n” numbers for VDZ q4w-Asian, VDZ q4w-non-Asian, VDZ q8w-Asian, and VDZ q8w-non-Asian were 9, 64, 6, and 64, respectively. VDZ, vedolizumab; PBO, placebo; q4w, every 4 weeks; q8w, every 8 weeks.


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