Intest Res.  2021 Jan;19(1):83-94. 10.5217/ir.2019.09160.

Efficacy and safety of vedolizumab in Crohn’s disease in patients from Asian countries in the GEMINI 2 study

• Banerjee R
• Chuah SW
• Hilmi IN
• Wu DC
• Yang SK
• Demuth D
• Lindner D
• Adsul S

• KMID: 2512104
• DOI: http://doi.org/10.5217/ir.2019.09160

Abstract

Background/Aims
The efficacy and safety of vedolizumab in moderate-to-severely active Crohn’s disease (CD) were demonstrated in the GEMINI 2 study (NCT00783692). This post-hoc exploratory analysis aimed to assess the efficacy and safety of vedolizumab in the subgroup of patients from Asian countries.
Methods
During the induction phase (doses at day 1, 15), clinical remission, enhanced clinical response, and change in C-reactive protein at 6 weeks; during the maintenance phase, clinical remission, enhanced clinical response, glucocorticoid-free remission and durable clinical remission at 52 weeks, were the efficacy outcomes of interest. Efficacy and safety of vedolizumab compared to placebo were assessed in Asian countries (Hong Kong, India, Malaysia, Singapore, South Korea, and Taiwan) using descriptive analyses.
Results
During the induction phase, in Asian countries (n = 51), 14.7% of the vedolizumab-treated patients achieved clinical remission at week 6 compared to none with placebo (difference, 14.7%; 95% confidence interval, 15.8%–43.5%). In non-Asian countries (n = 317), the remission rate at week 6 with vedolizumab was 14.5%. During maintenance, in Asian countries, clinical remission rates at 52 weeks with vedolizumab administered every 4 weeks, vedolizumab administered every 8 weeks and placebo were 41.7%, 36.4%, and 0%, respectively; while enhanced clinical response rates were 41.7%, 63.6%, and 42.9%, respectively. During induction, 39.7% of patients with vedolizumab experienced an adverse event compared to 58.8% of patients with placebo, and vedolizumab was generally well-tolerated.
Conclusions
This post-hoc analysis demonstrates the treatment effect and safety of vedolizumab in moderateto-severely active CD in patients from Asian countries.

Keyword

Vedolizumab; Crohn disease; Asia; Remission; Maintenance

Figure

• 

  Fig. 1. GEMINI 2 study schematic with number of patients in each treatment arm. During the induction phase, the Asian subgroup included 34 patients randomized to vedolizumab (cohort 1) and 17 to placebo; 24 patients received open-label vedolizumab. During the maintenance phase, in the Asian subgroup, 7 patients were randomized to placebo and 23 patients to the vedolizumab groups.

• 

  Fig. 2. Comparison of efficacy results for vedolizumab (VDZ) versus placebo (PBO) in the Asian countries subgroup in GEMINI 2 patients (A) in the induction phase, in the induction intent-to-treat (ITT) population, the rates of clinical remission and enhanced clinical response were numerically higher with VDZ compared to PBO, (B) in the maintenance phase, in the maintenance ITT population, the rates of remission and response were numerically higher with the VDZ groups compared to PBO. 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 5, 5, and 3, respectively. q4w, every 4 weeks; q8w, every 8 weeks.

• 

  Fig. 3. Comparison of efficacy results for vedolizumab (VDZ) versus placebo (PBO) in the non-Asian countries subgroup in GEMINI 2 patients (A) in the induction phase, in the induction intent-to-treat (ITT) population, the rates of clinical remission and enhanced clinical response were numerically higher with VDZ compared to PBO, (B) in the maintenance phase, in the maintenance ITT population, the efficacy rates were higher in both VDZ groups compared to PBO 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 75, 77, and 79, respectively. q4w, every 4 weeks; q8w, every 8 weeks.

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