Clin Gastroenterol Hepatol. 2022 Dec;20(12):2868-2875.e1.doi: 10.1016/j.cgh.2022.02.055. Epub 2022 Mar 8.

Shomron Ben-Horin ¹, Ofir Har-Noy ², Konstantinos H Katsanos ³, Xavier Roblin ⁴, Minhu Chen ⁵, Xiang Gao ⁶, Doron Schwartz ⁷, Jae Hee Cheon ⁸, Monica Cesarini ⁹, Daniela Bojic ¹⁰, Marijana Protic ¹⁰, Angeliki Theodoropoulou ¹¹, Heba Abu-Kaf ⁷, Tal Engel ², Jian Tang ⁶, Pauline Veyrard ⁴, Xiaoqing Lin ⁵, Ren Mao ⁵, Dimitrios Christodoulou ³, Konstantinos Karmiris ¹¹, Tamara Knezevic-Ivanovski ¹⁰; ComboMesa investigators

Author information

¹Sheba Medical Center, Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel; The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China. Electronic address: shomron.benhorin@gmail.com.

²Sheba Medical Center, Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel.

³Division of Gastroenterology, School of Health Sciences, University of Ioannina, Ioannina, Greece.

⁴Department of Gastroenterology, University-Hospital of Saint-Etienne, Saint Etienne, France.

⁵The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.

⁶The Sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.

⁷Department of Gastroenterology and Hepatology, Soroka University Medical Center, Beer-Sheva, Israel.

⁸Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.

⁹Dipartimento di Medicina Interna e Specialità Mediche, "Sapienza", University of Rome, Rome, Italy.

¹⁰Department of Gastroenterology, University Hospital Zvezdara, Belgrade, Serbia.

¹¹Department of Gastroenterology, Venizeleio General Hospital, Heraklion, Crete, Greece.

Abstract

Background & aims: Corticosteroids are the mainstay of treatment for hospitalized patients with acute severe ulcerative colitis (ASUC). However, whether the addition/continuation of mesalamine with corticosteroids during hospitalization is superior to corticosteroids alone is unknown.

Methods: This was a randomized controlled, investigator-blinded, clinical trial conducted in 10 centers in 7 countries. Patients hospitalized with ASUC (Lichtiger score ≥10) were eligible. Patients received corticosteroids alone or corticosteroid + mesalamine (4 g/day mesalamine) by a stratified randomization according to mesalamine use before 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: Three hundred forty-six patients were screened, and 149 were included (70/149 female; median age, 41 years). Of these, 73 received corticosteroids + mesalamine, and 76 received corticosteroids alone. For the primary outcome, 53 of 73 patients (72.6%) receiving corticosteroids with mesalamine responded versus 58 of 76 patients (76.3%) on corticosteroids alone (odds ratio, 0.82; 95% confidence interval, 0.39-1.72; P = .60). There was no difference between groups in duration of hospitalization, C-reactive protein normalization rate, or colectomy rate up to day 90. The need for biologics among patients receiving combination of corticosteroids with mesalamine was numerically lower by day 30 (P = .11) and day 90 (P = .07).

Conclusions: In this randomized controlled trial, combination of mesalamine with corticosteroids did not benefit hospitalized patients with ASUC more than corticosteroids alone. An exploratory signal for a reduced need for biologics at 90 days in the mesalamine group merits further evaluation.

Clinicaltrials: gov ID: NCT01941589.