[en] BACKGROUND & 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 patients with chronic pouchitis receiving ustekinumab intravenously at baseline (∼6 mg/kg) and 90 mg ustekinumab subcutaneously every 8 weeks thereafter. The Modified Pouchitis Disease Activity Index (mPDAI) was assessed at baseline and weeks 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 weeks 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 weeks 16 and 48. The median mPDAI decreased from 8 (interquartile range [IQR], 7-10) to 7 (IQR, 4-9) at week 16 (P = .007) and 4 (IQR, 1.75-7.25) at week 48 (P < .001). The clinical mPDAI subscore decreased from 3.5 (IQR, 2-4) to 2 (IQR, 1-3) at week 16 (P = .009) and 1 (IQR, 0-2.25) at week 48 (P = .001). The endoscopic mPDAI subscore decreased from 5.5 (IQR, 4-6) to 4 (IQR, 3-6) at week 16 (P = .032) and 3 (IQR, 1.75-4.25) at week 48 (P = .001). CONCLUSION: Ustekinumab was efficacious in one-half of the patients suffering from chronic pouchitis. Ustekinumab should therefore be positioned in the treatment algorithm of chronic pouchitis. (ClinicalTrials.gov Number NCT04089345).
Disciplines :
Gastroenterology & hepatology
Author, co-author :
Outtier, An; Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium, Translational Research in Gastrointestinal Disorders, Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium.
Louis, Edouard ; Université de Liège - ULiège > Département des sciences cliniques > Hépato-gastroentérologie
Dewit, Olivier; Department of Gastroenterology, Cliniques Universitaires Saint-Luc, Brussels, Belgium.
Reenaers, Catherine ; Université de Liège - ULiège > Département des sciences biomédicales et précliniques
Schops, Ganel; Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.
Lenfant, Matthias; Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium, Translational Research in Gastrointestinal Disorders, Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium.
Pontus, Emilie; Department of Gastroenterology, Cliniques Universitaires Saint-Luc, Brussels, Belgium.
De Hertogh, Gert; Department of Pathology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.
Verstockt, Bram; Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium, Translational Research in Gastrointestinal Disorders, Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium.
Sabino, João; Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium, Translational Research in Gastrointestinal Disorders, Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium.
Vermeire, Séverine; Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium, Translational Research in Gastrointestinal Disorders, Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium.
Ferrante, Marc; Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium, Translational Research in Gastrointestinal Disorders, Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium. Electronic address: marc.ferrante@uzleuven.be.
Language :
English
Title :
Efficacy and Safety of Ustekinumab for Chronic Pouchitis: A Prospective Open-label Multicenter Study.
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