Results from a phase 4 research published in The New England Journal of Medicine revealed that Vedolizumab appeared beneficial in lowering intestinal inflammation and eliciting remission in patients who acquired chronic pouchitis after undergoing ileal pouch-anal anastomosis (IPAA) for ulcerative colitis.

Around half of the ulcerative colitis patients with restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) primarily develop pouchitis, with one-fifth developing chronic pouchitis.

Researchers found 102 adult patients who met the trial criteria between October 2016 and March 2020. Individuals were eligible if they had undergone proctocolectomy at least one year before screening and had active chronic pouchitis, as indicated by a modified Pouchitis Disease Activity Index (mPDAI) score of 5 or above and a minimum subscore of 2 on the endoscopic domain.

During a 28-day screening period, patients were randomly randomized to receive 300 mg of intravenous Vedolizumab or placebo on day 1 and at weeks 2, 6, 14, 22, and 30 in a 1:1 ratio. Overall, 36 patients in the vedolizumab group (71%) and 32 patients in the placebo group (63%) completed treatment and received all infusions through week 30.

A post-hoc analysis discovered that regardless of whether concomitant antibiotics were taken before week 14 or 34, a substantial percentage of patients in the vedolizumab group achieved remission. At 14 weeks, 16 of 51 vedolizumab patients (31%) and five of 51 placebo patients (10%) achieved mPDAI-defined remission (a 21-percentage point difference; 95% CI, 5-38; P =.01). 35% of the vedolizumab group and 18% of the placebo group were in remission at week 34.

Severe adverse events occurred in 6% of vedolizumab patients compared to 8% of placebo patients.

Thus, the trial results revealed that the Vedolizumab drug was more successful than the placebo in producing remission in individuals with chronic pouchitis following IPAA for ulcerative colitis.

 (Source: https://www.medscape.com/viewarticle/990406#vp_1

https://www.nejm.org/doi/10.1056/NEJMoa2208450)