Effectiveness and safety of ustekinumab induction therapy for 103 patients with ulcerative colitis: a GETAID multicentre real-world cohort study.

Abstract

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.

• Authors: Aurélien Amiot, Jérôme Filippi, Vered Abitbol, Guillaume Cadiot, David Laharie, Melanie Serrero, Romain Altwegg, Yoram Bouhnik, Laurent Peyrin-Biroulet, Cyrielle Gilletta, Xavier Roblin, Guillaume Pineton de Chambrun, Lucine Vuitton, Anne Bourrier, Stephane Nancey, Jean-Marc Gornet, Stephane Nahon, Guillaume Bouguen, Stephanie Viennot, Benjamin Pariente, Mathurin Fumery, UC-USK-GETAID Study Group
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 51 Issue 11 Pg. 1039-1046 (06 2020) ISSN: 1365-2036 [Electronic] England
• PMID: 32291786 (Publication Type: Journal Article, Multicenter Study)
• Copyright: © 2020 John Wiley & Sons Ltd.

Chemical References

• Ustekinumab

Topics

• Adult
• Cohort Studies
• Colitis, Ulcerative (drug therapy, epidemiology)
• Drug Resistance (drug effects)
• Female
• France (epidemiology)
• Humans
• Induction Chemotherapy (adverse effects, methods)
• Male
• Middle Aged
• Remission Induction
• Retrospective Studies
• Treatment Outcome
• Ustekinumab (adverse effects, therapeutic use)