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Article Dans Une Revue Alimentary Pharmacology and Therapeuthics Année : 2021

Effectiveness and safety of ustekinumab maintenance therapy in 103 patients with ulcerative colitis: a GETAID cohort study

Mathurin Fumery
Vered Abitbol
  • Fonction : Auteur
Melanie Serrero
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Yoram Bouhnik
Anne Bourrier
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Stephane Nancey
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Jean-Marc Gornet
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Stephanie Viennot
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Aurelien Amiot
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Résumé

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.
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Dates et versions

hal-03336375 , version 1 (07-09-2021)

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Mathurin Fumery, Jerome Filippi, Vered Abitbol, Amelie Biron, David Laharie, et al.. Effectiveness and safety of ustekinumab maintenance therapy in 103 patients with ulcerative colitis: a GETAID cohort study. Alimentary Pharmacology and Therapeuthics, 2021, 54 (7), p.944-951. ⟨10.1111/apt.16544⟩. ⟨hal-03336375⟩
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