Mucosal Healing and Clinical Efficacy of Adalimumab in Small Intestinal Crohn's Disease (SIMCHA Study): Final Results From a Prospective, Open-Label, Single-Arm Study

Endoscopic healing is a key treatment target in inflammatory bowel disease; few data are available on the clinical and endoscopic efficacy of biological therapy in upper gastrointestinal Crohn's disease. This study aimed to investigate small bowel mucosal healing and clinical efficacy of adalim...

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Bibliographic Details
Published in:The Turkish journal of gastroenterology 2023-06, Vol.34 (6), p.603-610
Main Authors: Wetwittayakhlang, Panu, Verdon, Christine, Starr, Michael, Hahn, Gustavo Drügg, Golovics, Petra A, Bessissow, Talat, Afif, Waqqas, Wild, Gary, Bitton, Alain, Lakatos, Peter L
Format: Article
Language:English
Subjects:
Adalimumab
Adalimumab - therapeutic use
C-Reactive Protein
Crohn Disease - drug therapy
Crohn's disease
Drug therapy
Endoscopy
Gastrointestinal mucosa
GASTROINTESTINAL TRACT
Health aspects
Humans
Leukocyte L1 Antigen Complex
Original
Patient outcomes
Prospective Studies
Remission Induction
Treatment Outcome
Wound healing
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Summary:Endoscopic healing is a key treatment target in inflammatory bowel disease; few data are available on the clinical and endoscopic efficacy of biological therapy in upper gastrointestinal Crohn's disease. This study aimed to investigate small bowel mucosal healing and clinical efficacy of adalimumab therapy by video capsule endoscopy in patients with endoscopically active upper gastrointestinal Crohn's disease. This prospective, open-label, single-arm study included Crohn's disease patients with moderate-severe endoscopic proximal small bowel involvement, defined by a Lewis score >790. Patients were treated with adalimumab monotherapy for 24 weeks. Co-primary outcomes were endoscopic healing, defined as Lewis score 50% decrease in Lewis score. Secondary outcomes included clinical (Harvey-Bradshaw index
ISSN:1300-4948
2148-5607
DOI:10.5152/tjg.2023.22527