Early mucosal healing with infliximab is associated with improved long-term
clinical outcomes in ulcerative colitis.
Author(s): Colombel JF, Rutgeerts P, Reinisch W, Esser D, Wang Y, Lang Y, Marano CW, Strauss
R, Oddens BJ, Feagan BG, Hanauer SB, Lichtenstein GR, Present D, Sands BE,
Sandborn WJ.
Affiliation(s): Department of Hepatogastroenterology, Hopital Claude Huriez, CHU Lille and
INSERM-CIC9301, Universite Lille Nord de France.
jean-frederic.colombel@chru-lille.fr
Publication date & source: 2011, Gastroenterology. , 141(4):1194-201
BACKGROUND & AIMS: In the Active Ulcerative Colitis Trial (ACT)-1 and ACT-2,
patients with ulcerative colitis treated with infliximab were more likely than
those given placebo to have a clinical response, undergo remission, and have
mucosal healing. We investigated the association between early improvement (based
on endoscopy) and subsequent clinical outcome.
METHODS: Patients underwent endoscopic evaluations at weeks 0, 8, 30, and 54
(ACT-1 only), and were categorized into 4 subgroups by week 8 (Mayo endoscopy
subscore, 0-3). The association of week 8 endoscopy subscores, subsequent
colectomy risk, symptoms and corticosteroid use outcomes were analyzed. Mucosal
healing was defined as a Mayo endoscopy subscore of 0 (normal) or 1 (mild).
RESULTS: Infliximab-treated patients with lower week 8 endoscopy subscores were
less likely to progress to colectomy through 54 weeks of follow-up evaluation
(P=.0004). This trend was not observed among patients given placebo (P=.47).
Patients with lower endoscopy subscores achieved better symptomatic and
corticosteroid use outcomes at weeks 30 and 54 (P<.0001, infliximab; P<.01,
placebo). Among patients who achieved clinical response at week 8, trends in
subsequent clinical outcomes by week 8 endoscopy subscores were generally
consistent with that for the overall patient population; no trends were observed
among patients who achieved clinical remission.
CONCLUSIONS: The degree of mucosal healing after 8 weeks of infliximab was
correlated with improved clinical outcomes including colectomy. Similar trends
were observed for all outcomes except colectomy among the subgroup with clinical
response at week 8. The degree of mucosal healing at week 8 among those in
clinical remission did not predict subsequent disease course.
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