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

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.

Comparative Effectiveness of Second-Line Biological Therapies for Ulcerative Colitis and Crohn’s Disease in Patients With Prior Failure of Anti-Tumour Necrosis Factor Treatment

“…[20] The concomitant use of tofacitinib and immunomodulators is contraindicated; therefore, only patients who received vedolizumab showed concomitant use of immunomodulators in the baseline analysis of UC patients. [21] Likewise, for patients with CD, most of the baseline characteristics were similar between the two drug groups, with a few exceptions. The CDAI score, for instance, was higher in the ustekinumab group than in the vedolizumab group.…”

Vedolizumab in Inflammatory Bowel Disease: West versus East

“…Similarly, in moderate–to-severe CD Japanese patients, vedolizumab was not found to be better than placebo at both 10 weeks (CDAI-100 response) and 60 weeks (clinical remission) [103]. However, data from post hoc analysis of UC patients in the GEMINI 1 trial from Asian countries have shown efficacy and safety of vedolizumab to be broadly consistent with that of overall study population [104]. Moreover, pharmacokinetic profile of vedolizumab was found to be similar between Asians and non-Asian moderate-to-severe UC and CD, thus supporting the use of vedolizumab flat-fixed dosing in Asian patients as well [105].…”

Vedolizumab does not increase perioperative surgical complications in patients with inflammatory bowel disease, cohort study

“…1 Introduction of biologics has offered a hope that with improved disease control rates of surgical interventions for disease management will be reduced. [2][3][4] However, after an initial decrease, [5][6][7][8] rates of sur-tion is specific to the gut, however, concerns remain about overall effects on perioperative surgical complications. [11][12][13] Initial report by Lightner et al 9 indicated increase in rates of perioperative infectious complications.…”

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gery have plateaued for both ulcerative colitis (UC) and Crohn' s disease (CD) while significant concerns have been raised about increasing rates of peri-operative complications. [2][3][4] Anti-tumor necrosis factor (anti-TNF) medications, in particular infliximab, have been shown to increase rates or perioperative infectious complications although this data remains controversial. 3,[8][9][10] It has also been suggested that concerns about anti-TNF related surgical complications is at least in part responsible for the increased rate of 3 stage surgery for UC in the United States.

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