Effectiveness and safety of ustekinumab maintenance therapy in 103 patients with ulcerative colitis: a GETAID cohort study. Issue 7 (23rd July 2021)

• Record Type: Journal Article
• Authors: Fumery, Mathurin; Filippi, Jérôme; Abitbol, Vered; Biron, Amélie; Laharie, David; Serrero, Melanie; Altwegg, Romain; Bouhnik, Yoram; Peyrin‐Biroulet, Laurent; Gilletta, Cyrielle; Roblin, Xavier; Pineton de Chambrun, Guillaume; Vuitton, Lucine; Bourrier, Anne; Nancey, Stephane; Gornet, Jean‐Marc; Nahon, Stephane; Bouguen, Guillaume; Viennot, Stephanie; Nachury, Maria; Amiot, Aurelien
• Other Names: Brazier Franck investigator.; Yzet Clara investigator.; Hebuterne Xavier investigator.; Cadiot Guillaume investigator.; Brixi Hedia investigator.; Rivière Pauline investigator.; Poullenot Florian investigator.; Treton Xavier investigator.; Stefanescu Carmen investigator.; Zallot Camille investigator.; Beaugerie Laurent investigator.; Seksik Philippe investigator.; Sokol Harry investigator.; Kirchgesner Julien investigator.; Boschetti Gilles investigator.; Flourié Bernard investigator.; Gay Claire investigator.; Danion Pauline investigator.; Venturin Chloe investigator.; Allez Matthieu investigator.; Baudry Clotilde investigator.; Pariente Benjamin investigator.; Wils Pauline investigator.; Gagnière Charlotte investigator.; Tannoury Jenny investigator.
• Is Part Of: Alimentary pharmacology & therapeutics. Volume 54:Issue 7(2021)
• Page Start: 944
• Page End: 951
• Publication Date: 2021-07-23
• Subjects: Digestive organs -- Diseases -- Treatment -- Periodicals; Digestive organs -- Effect of drugs on -- Periodicals; Gastrointestinal system -- Diseases -- Treatment -- Periodicals; Gastrointestinal system -- Effect of drugs on -- Periodicals; 615.73
• DOI: 10.1111/apt.16544
• Languages: English
• ISSNs: 0269-2813

Abstract

Summary: Background: Phase III trials have demonstrated the efficacy and safety of ustekinumab in ulcerative colitis (UC), but few real‐life long‐term data are currently available. Aims: To assess the real‐world effectiveness and safety of ustekinumab in patients with UC. Methods: From January to September 2019, all consecutive patients with active UC treated with ustekinumab in a GETAID centre were included. Patients were evaluated at week 52. Remission was defined as a partial Mayo Clinic score ≤2. Results: We included 103 patients with UC (62 men; mean age: 41.2 ± 16.2 years; 52% pancolitis E3) with an insufficient response to immunosuppressants, anti‐TNFs and/or vedolizumab. At week 52, 45 (44%) patients had discontinued ustekinumab mainly due to lack of effectiveness (n = 41). The cumulative probabilities of ustekinumab persistence were 96.1%, 81.6%, 71.7% and 58.4% after 3, 6, 9 and 12 months respectively. The overall steroid‐free clinical remission rate at week 52 was 32% of whom 71% had subscores of null for rectal bleeding and stool frequency. Ten patients underwent colectomy within a median of 6.7 [4.3‐10.6] months. Adverse effects were observed in 15 (16.9%) patients; 4 (4.5%) were severe, including one patient who died from a myocardial infarction. Conclusion: After 52 weeks, over one‐half of patients with refractory UC were still treated by ustekinumab and one‐third were in steroid‐free clinical remission. Abstract : Among 103 patients with ulcerative colitis treated with ustekinumab, one‐third achieved steroid‐free clinical remission and less than 10% were referred to surgery, after a 1‐year follow‐up period. https://doi.org/10.1111/apt.16544