Definition of mild to moderate ulcerative colitis in clinical trials: A systematic literature review

被引：13

作者：

Caron, Benedicte ^{[1
,2
]}

Jairath, Vipul ^{[3
,4
,5
]}

D'Amico, Ferdinando ^{[6
,7
,8
]}

Paridaens, Kristine ^{[9
]}

Magro, Fernando ^{[10
,11
,12
]}

Danese, Silvio ^{[6
,7
]}

Peyrin-Biroulet, Laurent ^{[1
,2
]}

机构：

[1] Univ Lorraine, Nancy Univ Hosp, Dept Gastroenterol, 1 Allee Morvan, F-54511 Nancy, France

[2] Univ Lorraine, Nancy Univ Hosp, INSERM, NGERE U1256, 1 Allee Morvan, F-54511 Nancy, France

[3] Western Univ, Dept Med, London, ON, Canada

[4] Western Univ, Dept Epidemiol & Biostat, London, ON, Canada

[5] Alimentiv Inc, London, ON, Canada

[6] IRCCS Osped San Raffaele, Gastroenterol & Endoscopy, Milan, Italy

[7] Univ Vita Salute San Raffaele Milano, Milan, Italy

[8] Humanitas Univ, Dept Biomed Sci, Milan, Italy

[9] Ferring Int Ctr, St Prex, Switzerland

[10] Univ Porto, Fac Med, Unit Pharmacol & Therapeut, Dept Biomed, Porto, Portugal

[11] Sao Joao Univ Hosp Ctr CHUSJ, Dept Clin Pharmacol, Porto, Portugal

[12] Univ Porto, Fac Med, Ctr Hlth Technol & Serv Res CINTESIS, Porto, Portugal

来源：

UNITED EUROPEAN GASTROENTEROLOGY JOURNAL | 2022年 / 10卷 / 08期

关键词：

definition; mild; moderate; predictive factor; ulcerative colitis; RELEASE ORAL MESALAMINE; INFLAMMATORY-BOWEL-DISEASE; 400 MG TABLETS; DOUBLE-BLIND; BECLOMETHASONE DIPROPIONATE; MESALAZINE TABLETS; BUDESONIDE FOAM; MMX MESALAZINE; DOUBLE-DUMMY; EFFICACY;

D O I：

10.1002/ueg2.12283

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

We performed a systematic review to investigate the definition of mild to moderate active ulcerative colitis (UC), and to describe predictors of good response to treatment in clinical trials assessing 5-ASA and/or budesonide. Thirty-nine randomized controlled trials were included. The UC Disease Activity Index (UCDAI) was the most frequent score used for defining mild to moderate active UC (16 studies, 41%), followed by Clinical Activity Index in 11 studies (28.2%). Four different cut-offs were used to define mild to moderate active UC using the UCDAI. The most frequently reported predictors of good response to treatment was a mild and moderate disease activity. There is heterogeneity in the definition of mild to moderate active UC in randomized clinical trials. A standardized definition of mild to moderate active UC used for inclusion of patients in clinical trials is needed.

引用

页码：854 / 867

页数：14

共 59 条

[41] ECCO Guidelines on Therapeutics in Ulcerative Colitis: Medical Treatment [J].

Raine, Tim ;

Bonovas, Stefanos ;

Burisch, Johan ;

Kucharzik, Torsten ;

Adamina, Michel ;

Annese, Vito ;

Bachmann, Oliver ;

Bettenworth, Dominik ;

Chaparro, Maria ;

Czuber-Dochan, Wladyslawa ;

Eder, Piotr ;

Ellul, Pierre ;

Fidalgo, Catarina ;

Fiorino, Gionata ;

Gionchetti, Paolo ;

Gisbert, Javier P. ;

Gordon, Hannah ;

Hedin, Charlotte ;

Holubar, Stefan ;

Iacucci, Marietta ;

Karmiris, Konstantinos ;

Katsanos, Konstantinos ;

Kopylov, Uri ;

Lakatos, Peter L. ;

Lytras, Theodore ;

Lyutakov, Ivan ;

Noor, Nurulamin ;

Pellino, Gianluca ;

Piovani, Daniele ;

Savarino, Edoardo ;

Selvaggi, Francesco ;

Verstockt, Bram ;

Spinelli, Antonino ;

Panis, Yves ;

Doherty, Glen .

JOURNAL OF CROHNS & COLITIS, 2022, 16 (01) :2-17

[42] Budesonide Multimatrix Is Efficacious for Mesalamine-refractory, Mild to Moderate Ulcerative Colitis: A Randomised, Placebo-controlled Trial [J].

Rubin, David T. ;

Cohen, Russell D. ;

Sandborn, William J. ;

Lichtenstein, Gary R. ;

Axler, Jeffrey ;

Riddell, Robert H. ;

Zhu, Cindy ;

Barrett, Andrew C. ;

Bortey, Enoch ;

Forbes, William P. .

JOURNAL OF CROHNS & COLITIS, 2017, 11 (07) :785-791

[43] Induction of clinical and colonoscopic remission of mild-to-moderate ulcerative colitis with budesonide MMX 9 mg: pooled analysis of two phase 3 studies [J].

Sandborn, W. J. ;

Danese, S. ;

D'Haens, G. ;

Moro, L. ;

Jones, R. ;

Bagin, R. ;

Huang, M. ;

Ballard, E. David ;

Masure, J. ;

Travis, S. .

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2015, 41 (05) :409-418

[44] Delayed-Release Oral Mesalamine 4.8 g/day (800-mg Tablet) Is Effective for Patients With Moderately Active Ulcerative Colitis [J].

Sandborn, William J. ;

Regula, Jaroslaw ;

Feagan, Brian G. ;

Belousova, Elena ;

Jojic, Njegica ;

Lukas, Milan ;

Yacyshyn, Bruce ;

Krzeski, Piotr ;

Yeh, Chyon-Hwa ;

Messer, Christi A. ;

Hanauer, Stephen B. .

GASTROENTEROLOGY, 2009, 137 (06) :1934-1943

[45] Budesonide Foam Induces Remission in Patients With Mild to Moderate Ulcerative Proctitis and Ulcerative Proctosigmoiditis [J].

Sandborn, William J. ;

Bosworth, Brian ;

Zakko, Salam ;

Gordon, Glenn L. ;

Clemmons, David R. ;

Golden, Pamela L. ;

Rolleri, Robert L. ;

Yu, Jing ;

Barrett, Andrew C. ;

Bortey, Enoch ;

Paterson, Craig ;

Forbes, William P. .

GASTROENTEROLOGY, 2015, 148 (04) :740-U328

[46] Once-Daily Budesonide MMX® Extended-Release Tablets Induce Remission in Patients With Mild to Moderate Ulcerative Colitis: Results From the CORE I Study [J].

Sandborn, William J. ;

Travis, Simon ;

Moro, Luigi ;

Jones, Richard ;

Gautille, Theres ;

Bagin, Robert ;

Huang, Michael ;

Yeung, Phil ;

Ballard, E. David, II .

GASTROENTEROLOGY, 2012, 143 (05) :1218-+

[47] Repifermin (keratinocyte growth factor-2) for the treatment of active ulcerative colitis: a randomized, double-blind, placebo-controlled, dose-escalation trial [J].

Sandborn, WJ ;

Sands, BE ;

Wolf, DC ;

Valentine, JF ;

Safdi, M ;

Katz, S ;

Isaacs, KL ;

Wruble, LD ;

Katz, J ;

Present, DH ;

Loftus, EV ;

Graeme-Cook, F ;

Odenheimer, DJ ;

Hanauer, SB .

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2003, 17 (11) :1355-1364

[48] Safety and Efficacy of a New 3.3 g b.i.d. Tablet Formulation in Patients With Mild-to-Moderately-Active Ulcerative Colitis: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study [J].

Scherl, Ellen J. ;

Pruitt, Ronald ;

Gordon, Glenn L. ;

Lamet, Mark ;

Shaw, Audrey ;

Huang, Shirley ;

Mareya, Shadreck ;

Forbes, William P. .

AMERICAN JOURNAL OF GASTROENTEROLOGY, 2009, 104 (06) :1452-1459

[49] COATED ORAL 5-AMINOSALICYLIC ACID THERAPY FOR MILDLY TO MODERATELY ACTIVE ULCERATIVE-COLITIS - A RANDOMIZED STUDY [J].

SCHROEDER, KW ;

TREMAINE, WJ ;

ILSTRUP, DM .

NEW ENGLAND JOURNAL OF MEDICINE, 1987, 317 (26) :1625-1629

[50] Design of Clinical Trials for Mild to Moderate Ulcerative Colitis [J].

Sedano, Rocio ;

Jairath, Vipul ;

Ma, Christopher .

GASTROENTEROLOGY, 2022, 162 (04) :1005-1018

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