Corticosteroids and Mesalamine Versus Corticosteroids for Acute Severe Ulcerative Colitis: A Randomized Controlled Trial

ComboMesa investigators

doi:10.1016/j.cgh.2022.02.055

Corticosteroids and Mesalamine Versus Corticosteroids for Acute Severe Ulcerative Colitis: A Randomized Controlled Trial

ComboMesa investigators

Department of Internal Medicine

Research output: Contribution to journal › Article › peer-review

1 Citation (Scopus)

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.

Original language	English
Pages (from-to)	2868-2875.e1
Journal	Clinical Gastroenterology and Hepatology
Volume	20
Issue number	12
DOIs	https://doi.org/10.1016/j.cgh.2022.02.055
Publication status	Published - 2022 Dec

Bibliographical note

Funding Information:
Funding Supported by the Talpiot Medical Leadership grant of Sheba Medical Center (to SBH).

Funding Information:
Conflicts of interest These authors disclose the following: SBH has received consultancy and/or advisory board fees from Schering-Plough, AbbVie, Celltrion, Pfizer, Ferring, Janssen, Takeda; Galmed, BMS, and Novartis and has received research support from Celltrion, AbbVie, Janssen, Galmed, and Takeda. OHN received non-restricted educational grant from Ferring. XR has received consultancy and/or advisory board fees from MSD, AbbVie, Celltrion, Ferring, Janssen, Takeda, Gilead, and Amgen. DC has received fees for consulting/speaking from Janssen, MSD, Takeda, Pfizer, Ferring, and Galenica. KK has received speaker fees from AbbVie, Aenorasis, Janssen, MSD, Pfizer, and Takeda and consultancy or advisory board member fees from AbbVie, Amgen, Ferring, Galenica, Genesis, Janssen, MSD, Pfizer, and Takeda. MP was previously an employee of Tillotts Pharma. DS received speaker fees from Janssen, Takeda, AbbVie, Ferring, and Neopharm and consultancy/advisory fees from Rafa, Takeda, and AbbVie. The remaining authors disclose no conflicts.

Publisher Copyright:
© 2022 AGA Institute

All Science Journal Classification (ASJC) codes

Hepatology
Gastroenterology

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10.1016/j.cgh.2022.02.055

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@article{198aa4b949f54cb9aaed4a87e47afadd,

title = "Corticosteroids and Mesalamine Versus Corticosteroids for Acute Severe Ulcerative Colitis: A Randomized Controlled Trial",

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.",

author = "{ComboMesa investigators} and Shomron Ben-Horin and Ofir Har-Noy and Katsanos, {Konstantinos H.} and Xavier Roblin and Minhu Chen and Xiang Gao and Doron Schwartz and Cheon, {Jae Hee} and Monica Cesarini and Daniela Bojic and Marijana Protic and Angeliki Theodoropoulou and Heba Abu-Kaf and Tal Engel and Jian Tang and Pauline Veyrard and Xiaoqing Lin and Ren Mao and Dimitrios Christodoulou and Konstantinos Karmiris and Tamara Knezevic-Ivanovski",

note = "Funding Information: Funding Supported by the Talpiot Medical Leadership grant of Sheba Medical Center (to SBH). Funding Information: Conflicts of interest These authors disclose the following: SBH has received consultancy and/or advisory board fees from Schering-Plough, AbbVie, Celltrion, Pfizer, Ferring, Janssen, Takeda; Galmed, BMS, and Novartis and has received research support from Celltrion, AbbVie, Janssen, Galmed, and Takeda. OHN received non-restricted educational grant from Ferring. XR has received consultancy and/or advisory board fees from MSD, AbbVie, Celltrion, Ferring, Janssen, Takeda, Gilead, and Amgen. DC has received fees for consulting/speaking from Janssen, MSD, Takeda, Pfizer, Ferring, and Galenica. KK has received speaker fees from AbbVie, Aenorasis, Janssen, MSD, Pfizer, and Takeda and consultancy or advisory board member fees from AbbVie, Amgen, Ferring, Galenica, Genesis, Janssen, MSD, Pfizer, and Takeda. MP was previously an employee of Tillotts Pharma. DS received speaker fees from Janssen, Takeda, AbbVie, Ferring, and Neopharm and consultancy/advisory fees from Rafa, Takeda, and AbbVie. The remaining authors disclose no conflicts. Publisher Copyright: {\textcopyright} 2022 AGA Institute",

year = "2022",

month = dec,

doi = "10.1016/j.cgh.2022.02.055",

language = "English",

volume = "20",

pages = "2868--2875.e1",

journal = "Clinical Gastroenterology and Hepatology",

issn = "1542-3565",

publisher = "W.B. Saunders Ltd",

number = "12",

}

TY - JOUR

T1 - Corticosteroids and Mesalamine Versus Corticosteroids for Acute Severe Ulcerative Colitis

T2 - A Randomized Controlled Trial

AU - ComboMesa investigators

AU - Ben-Horin, Shomron

AU - Har-Noy, Ofir

AU - Katsanos, Konstantinos H.

AU - Roblin, Xavier

AU - Chen, Minhu

AU - Gao, Xiang

AU - Schwartz, Doron

AU - Cheon, Jae Hee

AU - Cesarini, Monica

AU - Bojic, Daniela

AU - Protic, Marijana

AU - Theodoropoulou, Angeliki

AU - Abu-Kaf, Heba

AU - Engel, Tal

AU - Tang, Jian

AU - Veyrard, Pauline

AU - Lin, Xiaoqing

AU - Mao, Ren

AU - Christodoulou, Dimitrios

AU - Karmiris, Konstantinos

AU - Knezevic-Ivanovski, Tamara

N1 - Funding Information: Funding Supported by the Talpiot Medical Leadership grant of Sheba Medical Center (to SBH). Funding Information: Conflicts of interest These authors disclose the following: SBH has received consultancy and/or advisory board fees from Schering-Plough, AbbVie, Celltrion, Pfizer, Ferring, Janssen, Takeda; Galmed, BMS, and Novartis and has received research support from Celltrion, AbbVie, Janssen, Galmed, and Takeda. OHN received non-restricted educational grant from Ferring. XR has received consultancy and/or advisory board fees from MSD, AbbVie, Celltrion, Ferring, Janssen, Takeda, Gilead, and Amgen. DC has received fees for consulting/speaking from Janssen, MSD, Takeda, Pfizer, Ferring, and Galenica. KK has received speaker fees from AbbVie, Aenorasis, Janssen, MSD, Pfizer, and Takeda and consultancy or advisory board member fees from AbbVie, Amgen, Ferring, Galenica, Genesis, Janssen, MSD, Pfizer, and Takeda. MP was previously an employee of Tillotts Pharma. DS received speaker fees from Janssen, Takeda, AbbVie, Ferring, and Neopharm and consultancy/advisory fees from Rafa, Takeda, and AbbVie. The remaining authors disclose no conflicts. Publisher Copyright: © 2022 AGA Institute

PY - 2022/12

Y1 - 2022/12

N2 - 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.

AB - 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.

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ER -

Corticosteroids and Mesalamine Versus Corticosteroids for Acute Severe Ulcerative Colitis: A Randomized Controlled Trial

Abstract

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