P312 Combination corticosteroids with 5-aminosalicylic acid versus corticosteroids alone in the treatment of hospitalized patients with acute severe ulcerative colitis: A multi-center randomized controlled trial
Ben-Horin, S.(1,2);Har-Noy, O.(1);Katsanos, K.H.(3);Xavier, R.(4);Chen, M.H.(2);Gao, X.(5);Schwartz, D.(6);Cheon, J.H.(7);Cesarini, M.(8);Bojic, D.(9);Protic, M.(9);Theodoropoulou, A.(10);Abu-Kaf, H.(6);Engel, T.(1);Tang, J.(5);Veyrard, P.(4);Lin, X.(2);Mao, R.(2);Christodoulou, D.(3);Karmiris, K.(10);Knezevic-Ivanovski, T.(9);
(1)Tel-HaShomer Sheba Medical Center, Department of Gastroenterology, Ramat Gan, Israel;(2)First affiliated Hospital of the Sun Yatsen University, Gastroenterology, Guangzhou, China;(3)University of Ioannina, Gastroenterology, Ioannina, Greece;(4)University-Hospital of Saint-Etienne, Gastroenterology, Saint-Etienne, France;(5)Sixth affiliated Hospital of the Sun Yatsen University, Gastroenterology, Guangzhou, China;(6)Soroka University Medical Center, Gastroenterology, Beer-Sheva, Israel;(7)Yonsei University College of Medicine, Gastroenterology, Seoul, Korea- Republic Of;(8)"Sapienza"- University of Rome, Gastroenterology, Rome, Italy;(9)University Hospital Zvezdara, Gastroenterology, Belgrade, Serbia;(10)Venizeleio General Hospital, Gastroenterology, Heraklion- Crete, Greece; ComboMesa
Background
Corticosteroids are the mainstay of treatment for hospitalized patients with acute severe ulcerative colitis (ASUC). However, whether the addition/continuation of 5-aminosalicylates (5ASA) with corticosteroids during hospitalization is superior to corticosteroids alone is unknown
Methods
This was a randomized controlled investigator-blinded clinical trial conducted in ten centers in six countries. Patients hospitalized with ASUC (Lichtiger score ≥10) were eligible. Patients received corticosteroids alone or corticosteroid+5ASA (4gr/day mesalamine) by a stratified randomization according to 5ASA use prior to admission. The primary outcome was the percentage of patients who responded to treatment by day 7, defined by a drop>3 points in the Lichtiger score and an absolute score<10 without the need for rescue medications or colectomy.
Results
346 patients were screened and 149 were included (70/149 females, median age 41). Of these, 73 received corticosteriods+5ASA and 76 corticosteroids alone. For the primary outcome, 53/73 (72.6%) of patients receiving corticosteroids with 5ASA responded versus 58/76 (76.3%) of patients on corticosteroids alone (OR 0.82 95%CI 0.39-1.72, p=0.60). There was no difference between groups in duration of hospitalization or CRP normalization rate. Colectomy rate up to day 90 was similar, but in an exploratory analysis the need for biologics among patients receiving combination corticosteroids with 5ASA was numerically lower by day 30 (p=0.11) and day 90 (p=0.07).
Conclusion
In this prospective randomized controlled trial, combination 5ASA with corticosteroids during hospitalization did not benefit patients admitted with ASUC more than corticosteroids alone. An exploratory finding of a reduced need for biologics at 90 days in the combination group merits further evaluation. ClinicalTrials.gov ID: NCT01941589