1. Effectiveness and safety of ustekinumab maintenance therapy in 103 patients with ulcerative colitis: a GETAID cohort study.
- Author
-
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, and Nachury, Maria
- Subjects
ULCERATIVE colitis ,COHORT analysis ,DISEASE remission ,MYOCARDIAL infarction ,INFLAMMATORY bowel diseases ,PATIENT safety - 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 FROM AUTHOR]
- Published
- 2021
- Full Text
- View/download PDF