EFFICACY AND SAFETY OF USTEKINUMAB FOR CHRONIC POUCHITIS: A PROSPECTIVE OPEN-LABEL MULTICENTER STUDY.

BACKGROUND AND AIMS

Seventeen percent of patients with ulcerative colitis that undergo proctocolectomy with pouch surgery will develop chronic pouchitis. We evaluated the efficacy of ustekinumab for these patients.

METHODS

We performed a prospective study of chronic pouchitis patients receiving ustekinumab intravenously at baseline (∼6mg/kg) and 90mg ustekinumab subcutaneously every 8 weeks thereafter. The modified pouchitis disease activity index (mPDAI) was assessed at baseline, week 16 and 48. The primary endpoint was the proportion of patients achieving steroid-free remission (mPDAI <5 and reduction by ≥2 points) at week 16. Secondary endpoints included the proportion of patients achieving remission at week 48, the proportion of patients achieving response (reduction of mPDAI by ≥2 points) at week 16 and 48, and change in mPDAI.

RESULTS

We enrolled 22 patients (59% male, median age 42.2 years). Remission was achieved in 27.3% at week 16 and 36.4% at week 48. Response was achieved in 54.5% both at week 16 and 48. The median (IQR) mPDAI decreased from 8 (7-10) to 7 (4-9) at week 16 (p=0.007) and 4 (1.75-7.25) at week 48 (p<0.001). The clinical mPDAI subscore decreased from 3.5 (2-4) to 2 (1-3) at week 16 (p=0.009) and 1 (0-2.25) at week 48 (p=0.001). The endoscopic mPDAI subscore decreased from 5.5 (4-6) to 4 (3-6) at week 16 (p=0.032) and 3 (1.75-4.25) at week 48 (p=0.001).

CONCLUSION

Ustekinumab was efficacious in half of the patients suffering from chronic pouchitis. Ustekinumab should therefore be positioned in the treatment algorithm of chronic pouchitis. (ClinicalTrials.gov Number NCT04089345).

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Copyright © 2024. Published by Elsevier Inc.