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Vedolizumab use in patients with inflammatory bowel diseases undergoing surgery: clinical trials and post-marketing experience.

ABSTRACT: Background:Patients with inflammatory bowel diseases frequently require surgery, but immunotherapies used in disease management may increase the risk of post-operative complications. We investigated frequencies of post-operative complications in patients who received vedolizumab-a gut-selective antibody approved for the treatment of moderately to severely active ulcerative colitis and Crohn's disease-in clinical-trial and post-marketing settings. Methods:This post hoc analysis of safety data from GEMINI 1, GEMINI 2, and long-term safety studies included patients who had had colectomy or bowel surgery/resection. Data from the post-marketing Vedolizumab Global Safety Database were also analysed (data cutoff point: 19 May 2016). Adverse events relating to post-operative complications were identified using Medical Dictionary for Regulatory Activities preferred terms. Results:Of 58 total surgeries in patients included in GEMINI 1 and GEMINI 2, post-operative complications were reported for 3/51 vedolizumab-treated patients (5.9%) and 1/7 placebo-treated patients (14.3%). In the long-term safety study, 157/2,243 patients (7%) had colectomy or bowel surgery/resection; of these 157 patients who underwent surgery, 11 (7%) experienced a post-operative complication. Median time between last pre-operative vedolizumab dose and surgery was 23?days in GEMINI 1, 20?days in GEMINI 2, and 39?40?days in the long-term safety study. In the post-marketing setting, based on data covering approximately 46,978 patient-years of vedolizumab exposure, post-operative complications were reported in 19 patients. Conclusions:In clinical trials, complications of colectomy and bowel surgery/resection appeared infrequent, with minimal difference between vedolizumab and placebo. The frequency of post-operative complications in the post-marketing setting appears low.

SUBMITTER: Shen B

PROVIDER: S-EPMC6821312 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Vedolizumab use in patients with inflammatory bowel diseases undergoing surgery: clinical trials and post-marketing experience.

Shen Bo B Blake Aimee A Lasch Karen K Smyth Michael M Bhayat Fatima F

Gastroenterology report 20190821 5

<h4>Background</h4>Patients with inflammatory bowel diseases frequently require surgery, but immunotherapies used in disease management may increase the risk of post-operative complications. We investigated frequencies of post-operative complications in patients who received vedolizumab-a gut-selective antibody approved for the treatment of moderately to severely active ulcerative colitis and Crohn's disease-in clinical-trial and post-marketing settings.<h4>Methods</h4>This post hoc analysis of ...[more]

PMID: 31687151

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Project description:Background and aimsExtraintestinal manifestations [EIMs] such as arthritis/arthralgia are common in inflammatory bowel disease. We performed post hoc analyses of data from the GEMINI studies to evaluate the effect of vedolizumab, a gut-selective anti-trafficking agent, on arthritis/arthralgia.MethodsSustained resolution of baseline arthritis/arthralgia, worsening of baseline arthritis/arthralgia, the occurrence of new arthritis/arthralgia, and the composite of new/worsening arthritis/arthralgia were evaluated. Cox modelling was used for time-to-event analysis. The influence of corticosteroid-tapering was also investigated.ResultsIn Crohn's disease [CD] patients, vedolizumab was significantly less likely than placebo to be associated with new/worsening arthritis/arthralgia (hazard ratio [HR], 0.63; 95% confidence interval [CI], 0.44-0.89). Similar incidences of sustained resolution of arthritis/arthralgia occurred with vedolizumab and placebo. In CD patients on corticosteroids at baseline, a decrease in corticosteroid dose increased the risk of new/worsening arthritis/arthralgia (odds ratio [OR], 7.49; 95% CI, 3.50-15.97) regardless of treatment; and in those achieving corticosteroid-free status, arthritis/arthralgia was less likely with vedolizumab than with placebo [HR, 0.14; 95% CI, 0.05-0.35]. In ulcerative colitis [UC] patients, vedolizumab and placebo showed a similar incidence of new/worsening of arthritis/arthralgia. In UC patients on corticosteroid at baseline, arthritis/arthralgia was more likely in those achieving corticosteroid-free status than in those continuing corticosteroids (HR 2.63 [95% CI 1.13-6.11]); and in those achieving corticosteroid-free status, the incidence of arthritis/arthralgia was similar with vedolizumab and placebo.ConclusionsVedolizumab therapy was associated with a reduced likelihood of new/worsening arthritis/arthralgia in CD and no increased incidence of these events in UC.Studies included [clincialtrials.gov, number]GEMINI 1 [NCT00783718]; GEMINI 2 [NCT00783692]; GEMINI 3 [NCT01224171].

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Vedolizumab use in patients with inflammatory bowel diseases undergoing surgery: clinical trials and post-marketing experience.

Publications

Vedolizumab use in patients with inflammatory bowel diseases undergoing surgery: clinical trials and post-marketing experience.

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