P393 Efficacy and Safety of Induction Therapy With Calcineurin Inhibitors in Combination With Ustekinumab for acute severe colitis.
Veyrard, P.(1);Pellet, G.(2);Laharie, D.(2);Nachury, M.(3);juillerat, P.(4);Altwegg, R.(5);Nancey, S.(6);Fumery, M.(7);Allez, M.(8);Tran minh, M.L.(9);Roblin, X.(10);
(1)CHU SAINT-ETIENNE, Gastroenterology, Saint-Priest-en-Jarez, France;(2)CHU Bordeaux, Gastroenterology, Bordeaux, France;(3)CHU Lille, Gastroenterology, Lille, France;(4)CH Bern Switzerland, Gastroenterology, Bern, Switzerland;(5)University Hospital Montpellier, Gastroenterology, montpellier, France;(6)University Hospital Lyon, Gastroenterology, lyon, France;(7)University hospital Amiens, Gastroenterology, Amiens, France;(8)Saint louis University Hospital, Gastroenterology, paris, France;(9)Saint Louis Universuty Hospital, Gastroenterology, Paris, France;(10)CHU Saint Etienne, Gastroenterology, saint priest en jarez, France;
Background
Ulcerative colitis is a chronic inflammatory bowel disease. 20% of patients will experienced acute severe colitis during their life. In acute severe colitis, when IV steroids failed, two strategies can be used with equivalent efficacy: Ciclosporin and Infliximab. Recently, Pellet et al reported the interest of association ciclosporin – vedolizumab. Regarding results from Varsity trial, more patients are treated before a CAG with vedolizumab. Recently, UNIFI trial showed the interest of ustekinumab in UC patients. So, it should be interesting to analyze the interest of the association Ciclosporin -Ustekinumab in case of acute severe ulcerative colitis. In this study, we retrospectively evaluated the clinical response and the rate of colectomy when we used anticalcineurin and Ustekinumab in acute severe colitis refractory to IV steroids.
Methods
All patients with acute severe colitis who failed to IV steroid and who were treated with calcineurin inhibitor and Ustekinumab, can be included. They were treated with a 6mg/kg infusion and then a 90mg subcutaneous injection every 8 weeks. Eight referral French center and a Switzerland referral center were involved in this study. The primary endpoint was clinical response at 6 months. We also evaluated the rate of colectomy and survival without Ustekinumab discontinuation. We reported also adverse events in this cohort.
Results
Eleven patients were included. 82% were women, with a median age of 32.2 years (range, 25.5-36.5 y). The median disease duration was 8.2 years (range, 3-9.5 y). Ten patients failed to Infliximab and 9 to Vedolizumab. At inclusion, median Lichtiger score, Mayo score and CRP were respectively 13,4 [IC95, 12.5-14.5], 10.6 [IC95, 10-11.5] et de 24.5 mg/L [IC95, 4.5-35.7mg/l]. The mean Endoscopic Mayo score was 2.6 +/-0.7. The median time between beginning of Calcineurin inhibitor and Ustekinumab was 22 days (minimum 6d, maximum 128d). Median follow-up was 11 months. None of the patients underwent colectomy at 6 months. The mean full Mayo score was significantly lower during the follow-up (10.6 at baseline and 1.0 at 6 months; p = 0.005). The mean CRP level was significantly reduced (from 24.5 mg / L [CI95, 4.5-35.7] to 2.6 mg / L [2-3.1], p = 0.02). Only one patient stopped ustekinumab at the end of follow-up. Two patients required treatment optimization. Tolerance to treatment was well with only one case of alopecia described without withdrawal of treatment.
Conclusion
In this retrospective study including patients hospitalized for IV Steroid-resistant acute severe colitis, the sequence of treatment with induction anti-calcineurin with ustekinumab therapy appears to be effective and well tolerated. These results need to be confirmed on a larger number of patients.