P504 Effectiveness and safety of ustekinumab maintenance therapy in 103 patients with real-world ulcerative colitis: A GETAID multicentre cohort study
Fumery, M.(1);Filippi, J.(2);Abitbol, V.(3);Biron, A.(4);Laharie, D.(5);Serrero, M.(6);Altwegg, R.(7);Bouhnik, Y.(8);Peyrinbiroulet, L.(9);Gilletta, C.(10);Roblin, X.(11);Pineton de Chambrun, G.(12);Vuitton, L.(13);Bourrier, A.(14);Nancey, S.(15);Gornet, J.M.(16);Nahon, S.(17);Bouguen, G.(18);Viennot, S.(19);Pariente, B.(20);Amiot, A.(21);
(1)Amiens University Hospital, Gastroenterology, Amiens Cedex 1, France;(2)Nice University Hospital, Gastroenterology, NIce, France;(3)Cochin Hospital, Gastroenterology, Paris, France;(4)Reims University hospital, Gastroenterology, Reims, France;(5)Bordeaux university hospital, Gastroenterology, Bordeaux, France;(6)Marseille University Hospital, Gastroenterology, Marseille, France;(7)Montpellier University Hospital, Gastroenterology, Montpellier, France;(8)Beaujon Hospital, Gastroenterology, Clichy, France;(9)Nancy University hospital, Gastroenterology, Nancy, France;(10)Toulouse University Hospital, Gastroenterology, Toulouse, France;(11)St Etienne University Hospital, Gastroenterology, Saint-Etienne, France;(12)Montpellier, Gastroenterology, Montpellier, France;(13)Besancon, Gastroenterology, Besancon, France;(14)Saint-Antoine Hospital, Gastroenterology, Paris, France;(15)Lyon Sud Hospital, Gastroenterology, Lyon, France;(16)Saint Louis Hospital, Gastroenterology, Paris, France;(17)Montfermeil Hospital, Gastroenterology, Montfermeil, France;(18)Rennes University Hospital, Gastroenterology, Rennes, France;(19)Caen University Hospital, Caen University Hospital, Caen, France;(20)Lille University Hospital, Gastroenterology, Lille, France;(21)Creteil University Hospital, Gastroenterology, Creteil, France; GETAID
Phase III trials have demonstrated the efficacy and safety of ustekinumab in moderate-to-severe ulcerative colitis (UC), but no real-life long-term data is currently available.
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 by a partial Mayo Clinic score ≤ 2. The aim of the present study was to assess long-term effectiveness and safety of ustekinumab in UC.
103 UC patients (62 men; mean age: 41.2 ± 16.2 years; 52% pancolitis E3) were included in 21 centres. History of immunomodulator, anti-TNF and vedolizumab therapies was noted in 84.5%, 99.0% and 85.4% of the cases, respectively. At week 54, 44 (43%) patients discontinued ustekinumab, for lack of efficacy (n=41), pregnancy (n=1), persistence of eczematiform lesions (n=1) or personal decision (n=1). Cumulative probabilities of ustekinumab persistence were 96.1%, 81.6%, 71.7%, and 58.4% after 3, 6, 9, and 12 months, respectively. In multivariate analysis, a CRP>5 mg/L at week 0 (OR=2.91, CI95%[1.15-7.36]; p=0.02) and concomitant steroids at week 0 (OR=3.05, CI95%[1.30-7.14]; p=0.01) were significantly associated with ustekinumab discontinuation within one year. The overall rate of steroid-free clinical remission at week 52 was 32% of whom 71% had null rectal bleeding and stool frequency subscores. Ten patients (9.7%) underwent colectomy within a median of 6.7 [4.3-10.6] months. Adverse events were observed in 15 (16.9%) patients, of whom 4 (4.5%) had severe adverse events including three patients with exacerbation of UC leading to hospitalization, and a 62 years-old men who died from a myocardial infarction four months after ustekinumab initiation.
In this real-world cohort study that included patients with refractory ulcerative colitis to multiple therapies, more than one-half of patients were still treated by ustekinumab and one-third were in steroid-free clinical remission, after 52 weeks.