P719 Effectiveness and safety of ustekinumab induction therapy in ulcerative colitis: A GETAID real-world cohort study
A. Amiot1, A. Vered2, J. Filippi3, G. Cadiot4, D. Laharie5, S. Melanie6, R. Altwegg7, Y. Bouhnik8, L. Peyrin-biroulet9, C. Gilletta10, X. Roblin11, G. Pineton de chambrun7, L. Vuitton12, A. Bourrier13, S. Nancey14, J.M. Gornet15, S. Nahon16, G. Bouguen17, S. Viennot18, P. Benjamin19, M. Fumery20, GETAID
1Gastroenterology, Henri Mondor Hospital, Creteil, France, 2Gastroenterology, Cochin Hospital, Paris, France, 3Gastroenterology, Nice University Hospital, Nice, France, 4Gastroenterology, Reims University Hospital, Reims, France, 5Gastroenterology, Bordeaux University Hospital, Bordeaux, France, 6Gastroenterology, Marseille University Hospital, Marseille, France, 7Gastroenterology, Montpellier University Hospital, Montpellier, France, 8Gastroenterology, Beaujon Hospital, Clichy, France, 9Gastroenterology, Nancy University Hospital, Nancy, France, 10Gastroenterology, Toulouse University Hospital, Toulouse, France, 11Gastroenterology, St Etienne, St Etienne, France, 12Gastroenterology, Besancon University Hospital, Besancon, France, 13Gastroenterology, St Antoine Hospital, Paris, France, 14Gastroenterology, Lyon University Hospital, Lyon, France, 15Gastroenterology, St Louis Hospital, Paris, France, 16Gastroenterology, Montfermeil Hospital, Montfermeil, France, 17Gastroenterology, Rennes University Hospital, Rennes, France, 18Gastroenterology, Caen University Hospital, Caen, France, 19Gastroenterology, Lille, Lille, France, 20Department of Gastroenterology and Hepatology, Amiens University Hospital, Amiens Cedex 1, France
Background
Phase III trials have demonstrated the efficacy and safety of ustekinumab in moderate-to-severe ulcerative colitis (UC), but no real-life data is currently available.
Methods
Between January and September 2019, all consecutive patients with UC treated with ustekinumab in 20 French GETAID centres were included. The primary outcome was steroid-free clinical remission (partial Mayo Clinic score ≤ 2) at weeks 12–16 without rectal bleeding subscore > 1.
Results
One hundred and three patients were included with a median age and disease duration of 39.3 [interquartile range (IQR), 29.1–52.3] and 7.6 [3.6–12.9] years, respectively. Most of the patients had left sided colitis (41.8%) or pancolitis (52.4%). History of immunomodulator, anti-TNF and vedolizumab therapies was noted in 84.5%, 99.0% and 85.4% of the cases, respectively. Steroid-free clinical remission and clinical remission rates were 35.0% and 39.8% at weeks 12–16, respectively. Normalisation of rectal bleeding and stool frequency (subscore 0 for both outcomes) was noted in 19.4% of patients whereas normalisation of rectal bleeding (subscore 0) with a stool frequency subscore of 0 or 1 was noted in 39.8%. Two patients discontinued ustekinumab before the weeks 12–16 visit and were referred to surgery. Predictors of therapeutic failure at weeks 12–16 were a partial Mayo Clinic score > 6 at week 0 (HR = 10.0, 95%CI [1.11––100.0],
Conclusion
In this first real-life cohort study of refractory UC patients treated with ustekinumab, clinical remission without corticosteroids was observed in one-third of cases at weeks 12–16. Clinical severity and previous use of anti-TNF and vedolizumab were associated with therapeutic failure.