Adalimumab induces and maintains mucosal healing in patients with Crohn's
disease: data from the EXTEND trial.
Author(s): Rutgeerts P, Van Assche G, Sandborn WJ, Wolf DC, Geboes K, Colombel JF, Reinisch
W; EXTEND Investigators, Kumar A, Lazar A, Camez A, Lomax KG, Pollack PF, D'Haens
G.
Collaborators: Miehsler W, Baert F, D'Haens G, Van Assche G, Van Gossum A, Enns
R, Greenbloom S, MacIntosh D, Panaccione R, Colombel JF, Raedler A, Schreiber S,
Zeitz M, Sostegni R, Stokkers P, Lofberg R, Barish C, Gordon G, Hanauer S, Hardi
R, Katz S, McCabe R, Sandborn W, Wolf D.
Affiliation(s): Department of Gastro-Enterologie, University Hospital of Gasthuisberg, Leuven,
Belgium. paul.rutgeerts@uzleuven.be
Publication date & source: 2012, Gastroenterology. , 142(5):1102-1111
BACKGROUND & AIMS: We investigated the efficacy of adalimumab for inducing
and maintaining mucosal healing in patients with Crohn's disease (CD).
METHODS: A randomized, double-blind, placebo-controlled trial (extend the safety
and efficacy of adalimumab through endoscopic healing [EXTEND]) evaluated
adalimumab for induction and maintenance of mucosal healing in 135 adults with
moderate to severe ileocolonic CD. The baseline degree of mucosal ulceration was
documented by ileocolonoscopy. All patients received induction therapy
(subcutaneous adalimumab 160/80 mg at weeks 0/2). At week 4, patients were
randomly assigned to groups given 40 mg adalimumab or placebo every other week
through week 52. Open-label adalimumab was given to patients with flares or no
response, starting at week 8. Mucosal healing was reassessed by ileocolonoscopy
at weeks 12 and 52.
RESULTS: Twenty-seven percent of patients receiving adalimumab had mucosal
healing at week 12 (the primary end point) versus 13% given placebo (P = .056).
At week 52, rates of mucosal healing were 24% and 0, respectively (P < .001).
Remission rates, based on the Crohn's Disease Endoscopic Index of Severity, were
52% for adalimumab and 28% for placebo at week 12 (P = .006) and 28% and 3%,
respectively, at week 52 (P < .001). Rates of clinical remission based on the
Crohn's Disease Activity Index were greater among patients given continuous
adalimumab therapy versus placebo at weeks 12 (47% vs 28%; P = .021) and 52 (33%
vs 9%; P = .001). Five serious (1 during induction and 4 during open-label
therapy) and 3 opportunistic infections (1 in each group during double-blind
therapy and 1 during open-label therapy) were reported (n = 135).
CONCLUSIONS: Following induction therapy with adalimumab, patients with
moderately to severely active CD who continue to receive adalimumab are more
likely to achieve mucosal healing than those given placebo.
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