Vedolizumab induces remission in more than 30% of UC patients with chronic pouchitis
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Key takeaways:
- Vedolizumab more effectively induced remission in UC patients with chronic pouchitis after IPPA compared with placebo.
- Adverse events were comparable with vedolizumab and placebo.
Vedolizumab more effectively induced remission compared with placebo in patients with chronic pouchitis following ileal pouch-anal anastomosis for ulcerative colitis, according to research in The New England Journal of Medicine.
“Idiopathic inflammation of the pouch — referred to as pouchitis — is the most common long-term complication of ileal pouch-anal anastomosis (IPAA); it develops in approximately half of patients within 5 years after undergoing IPAA and recurs in more than 50% of affected patients,” Simon Travis, DPhil, professor of clinical gastroenterology at the University of Oxford, and colleagues wrote.
“Acute pouchitis is usually treated with short-term courses of antibiotic agents; however, chronic pouchitis, which is defined by a symptom duration of longer than 4 weeks, occurs in approximately one-fifth of patients.”
To evaluate whether vedolizumab is effective in patients with antibiotic-refractory pouchitis after IPAA, Travis and colleagues conducted the phase 4, randomized, double-blind EARNEST trial. They enrolled 102 patients, who received 300 mg IV vedolizumab (n = 51; median age, 42 years; 63% men) or placebo (n = 51; median age, 45 years; 74% men) on day 1 and at weeks 2, 6, 14, 22 and 30. All patients received concomitant ciprofloxacin at a dose of 500 mg twice daily through week 4.
Researchers assessed modified Pouchitis Disease Activity Index (mPDAI)-defined remission (based on clinical symptoms and endoscopic findings) at weeks 14 and 34, as well as mPDAI-defined response and PDAI-defined remission (based on clinical symptoms and endoscopic and histologic findings) at weeks 14 and 34.
According to study results, a “significantly higher” proportion of patients in the vedolizumab group achieved mPDAI-defined remission at week 14 compared with placebo (31% vs. 10%). More patients in the vedolizumab group also achieved mPDAI-defined remission at week 34 (between group difference = 17%; 95% CI, 0-35), as well as PDAI-defined remission at weeks 14 and 34 (between group differences = 25%; 95% CI, 8-41 and 19%; 95% CI, 2-37, respectively).
Further, more patients had inflammatory bowel disease questionnaire-defined remission at week 34 with vedolizumab vs. placebo (difference = 24%; 95% CI, 5-41). There also was a higher rate of sustained mPDAI-defined remission among patients in the vedolizumab group (difference = 22%; 95% CI, 6-37).
Researchers reported adverse and serious adverse events among 92% and 6%, respectively, in the vedolizumab group and 86% and 8% in the placebo group.
“Among patients who had chronic pouchitis after undergoing IPAA for ulcerative colitis, treatment with vedolizumab was more effective than placebo in the induction of remission,” Travis and colleagues concluded.
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