Vedolizumab a Viable Treatment Option for Chronic Pouchitis in Ulcerative Colitis

Monoclonal antibody vedolizumab is more efficacious than placebo for inducing remission in patients who developed chronic pouchitis, following ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC). The study results were published in the New England Journal of Medicine.

Researchers conducted a phase 4, double-blind, randomized trial (ClinicalTrials.gov Identifier: NCT02790138) to evaluate the efficacy and safety of vedolizumab for treating chronic pouchitis over 34 weeks. Of 110 patients identified, researchers enrolled 102 in the study. Patients aged 18 to 80 were randomly assigned 1:1 to receive 300 mg intravenous (IV) vedolizumab or placebo on day 1 and at weeks 2, 6, 14, 22, and 30. All patients received the antibiotic ciprofloxacin from weeks 1 to 4.

The primary end point was modified Pouchitis Disease Activity Index (mPDAI)-defined remission at 14 weeks. The mPDAI-defined remission was measured by a reduction from baseline of at least 2 points in the mPDAI total score or an mPDAI score of less than or equal to 4. Secondary end points included mPDAI-defined remission at 34 weeks, mPDAI-defined response at 14 and 34 weeks, and PDAI-defined remission at 14 and 34 weeks.

By week 14, patients who received vedolizumab and placebo had a 31% and 10% incidence of mPDAI-defined remission, respectively (difference, 21 percentage points; 95% CI, 5-38; P =.01). Researchers observed similar results for mPDAI-defined response (difference, 30 percentage points; 95% CI, 8-48) and PDAI-defined remission (difference, 25 percentage points; 95% CI, 8-41) at 14 weeks.

By week 34, vedolizumab remained superior to placebo in mPDAI-defined remission (difference, 17 percentage points; 95% CI, 0-35), mPDAI-defined response (difference, 22 percentage points; 95% CI, 2-40), and PDAI-defined remission (difference, 19 percentage points; 95% CI, 2-37).

Study limitations include using PDAI and mPDAI measures that were not fully validated, patient use of additional antibiotics, and the need for longer-term efficacy and safety evaluations of vedolizumab for pouchitis.

“[V]edolizumab was more effective than placebo with respect to the primary end point of mPDAI-defined remission at week 14, with a 21 percentage-point difference between the groups in the percentage of patients with remission,” the study authors wrote. “The early treatment effect appeared to be sustained through week 34.”

Disclosure: This research was supported by Takeda. Some study authors declared affiliations with the biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.