Characterisation of Mucosal Healing with Adalimumab Treatment in Patients with Moderately to Severely Active Crohn's Disease: Results from the EXTEND Trial.
OBJECTIVE
Mucosal healing [MH] is an important goal for patients with Crohn's disease [CD], yet is incompletely characterised. We investigated whether MH differed by segments across the colon and ileum in patients who received adalimumab maintenance treatment in the EXTEND study.


METHODS
In this double-blind study in adults with moderate to severe ileocolonic CD and mucosal ulceration, all patients received adalimumab induction [Week 0, 160 mg; Week 2, 80 mg]. At Week 4, patients were randomised to 40 mg adalimumab or placebo every other week until Week 52. In this post-hoc analysis, MH was assessed by CD Endoscopic Index of Severity [CDEIS], Simple Endoscopic Score for CD [SES-CD], and Colonic and Ileal Global Histologic Disease Activity Scores [CGHAS/IGHAS].


RESULTS
Baseline endoscopic severity was similar across segments. At Week 52, mean changes in CDEIS surface involved and ulcerated surface were -68.5% to -90.6% in the rectum, sigmoid/left colon, and transverse colon compared with -22.3% to -50.0% in the right colon and ileum. Favourable shifts by Week 52 in ulcer size and ulcerated surfaces per SES-CD were more pronounced in the rectum, sigmoid/left colon, and transverse colon vs the right colon and ileum. At Week 52, CGHAS and IGHAS healing was more common in the colon [28.3%] vs the ileum [21.2%].


CONCLUSIONS
This analysis suggests differing propensities of the ileocolonic segments to heal endoscopically during adalimumab treatment. In the sigmoid/left and transverse colon, higher MH rates may be achieved, compared with the ileum, in patients with moderate to severe CD.
Division of Gastroenterology, Department of Medicine, McMaster University, Hamilton, ON, Canada; and Department of Internal Medicine III, Division of Gastroenterology & Hepatology, Medical University of Vienna, Vienna, Austria.
Walter
W
Reinisch
Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Jean-Frédéric
JF
Colombel
Department of Gastroenterology, Academic Medical Center, Amsterdam, The Netherlands; and Imelda GI Clinical Research Center, Bonheiden, Belgium.
Geert
G
D'Haens
Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.
William J
WJ
Sandborn
Division of Gastroenterology, Department of Internal Medicine, University of Leuven, Leuven, Belgium.
Paul
P
Rutgeerts
Department of Pathology, University of Leuven, Leuven, Belgium.
Karel
K
Geboes
Global Medical Affairs Gastroenterology, AbbVie Inc., North Chicago, IL, USA.
Joel
J
Petersson
Global Medical Affairs Gastroenterology, AbbVie Inc., North Chicago, IL, USA.
Samantha
S
Eichner
Data and Statistical Sciences, AbbVie Inc., North Chicago, IL, USA.
Qian
Q
Zhou
Global Medical Affairs Gastroenterology, AbbVie Inc., North Chicago, IL, USA.
Anne M
AM
Robinson
Global Medical Affairs Gastroenterology, AbbVie Inc., North Chicago, IL, USA.
Holly A
HA
Read
Global Medical Affairs Gastroenterology, AbbVie Inc., North Chicago, IL, USA.
Roopal
R
Thakkar
D000068879:Adalimumab / Q000627:therapeutic use*; D000328:Adult; D003113:Colonoscopy; D003424:Crohn Disease / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007413:Intestinal Mucosa / Q000473:pathology; D008297:Male; D016896:Treatment Outcome
D000068879:Adalimumab
Endoscopy; inflammatory bowel disease; mucosal ulceration