Effectiveness and safety of ustekinumab induction therapy for 103 patients with ulcerative colitis: a GETAID multicentre real‐world cohort study. Issue 11 (14th April 2020)

• Record Type: Journal Article
• Authors: Amiot, Aurélien; Filippi, Jérôme; Abitbol, Vered; Cadiot, Guillaume; 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; Pariente, Benjamin; Fumery, Mathurin
• Other Names: Amiot Aurélien investigator.; Gagnière Charlotte investigator.; Tannoury Jenny investigator.; Filippi Jérôme investigator.; Hebuterne Xavier investigator.; Abitbol Vered investigator.; Cadiot Guillaume investigator.; Brixi Hedia investigator.; Laharie David investigator.; Rivière Pauline investigator.; Poullenot Florian investigator.; Serrero Melanie investigator.; Altwegg Romain investigator.; Pineton de Chambrun Guillaume investigator.; Bouhnik Yoram investigator.; Treton Xavier investigator.; Stefanescu Carmen investigator.; Diderot Denis investigator.; Peyrin‐Biroulet Laurent investigator.; Zallot Camille investigator.; Gilletta Cyrielle investigator.; Roblin Xavier investigator.; Vuitton Lucine investigator.; Bourrier Anne investigator.; Beaugerie Laurent investigator.; Seksik Philippe investigator.; Sokol Harry investigator.; Kirchgesner Julien investigator.; Nancey Stephane investigator.; Boschetti Gilles investigator.; Flourié Bernard investigator.; Gay Claire investigator.; Danion Pauline investigator.; Venturin Chloe investigator.; Gornet Jean‐Marc investigator.; Allez Matthieu investigator.; Baudry Clotilde investigator.; Nahon Stephane investigator.; Bouguen Guillaume investigator.; Viennot Stephanie investigator.; Pariente Benjamin investigator.; Nachury Maria investigator.; Wils Pauline investigator.; Fumery Mathurin investigator.; Brazier Franck investigator.; Yzet Clara investigator.;
• Is Part Of: Alimentary pharmacology & therapeutics. Volume 51:Issue 11(2020)
• Page Start: 1039
• Page End: 1046
• Publication Date: 2020-04-14
• 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.15717
• Languages: English
• ISSNs: 0269-2813

Abstract

Summary: Background: Phase III trials have demonstrated the efficacy and safety of ustekinumab in moderate‐to‐severe ulcerative colitis (UC), but few real‐world data are currently available. Aim: To assess short‐term effectiveness and safety of ustekinumab in patients with UC. Methods: From January to September 2019, all patients with UC treated with ustekinumab in 20 French GETAID centres were retrospectively included. The primary outcome was steroid‐free clinical remission (partial Mayo Clinic score ≤2) at weeks 12‐16 without a rectal bleeding subscore >1. Results: Among the 103 patients included, 70% had been previously exposed to ≥2 anti‐TNF agents and 85% to vedolizumab. At weeks 12‐16, steroid‐free clinical remission and clinical remission rates were 35.0% and 39.8% respectively; the absence of rectal bleeding with normal stool frequency was noted in 19.4% of patients. Two patients discontinued ustekinumab before the week 12‐16 visit and underwent surgery. In multivariable analysis, a partial Mayo Clinic score >6 at inclusion (18.6% vs 46.7%, P = 0.003) and a history of both exposure to anti‐TNF and vedolizumab therapies (27.3% vs 80.0%, P = 0.001) were negatively associated with steroid‐free clinical remission at weeks 12‐16. Adverse events occurred in 7.8% of patients and serious adverse events in 3.9% of patients. Conclusion: In a cohort of highly refractory patients with UC with multiple prior drug failures, ustekinumab provided steroid‐free clinical remission in one‐third of cases at weeks 12‐16. Clinical severity and previous use of anti‐TNF and vedolizumab therapies were associated with ustekinumab failure at weeks 12‐16.