About two-thirds of patients with Crohn’s disease and symptomatic small bowel stricture had a successful response to treatment with Humira, and long-term success was maintained in almost half of responders, according to results from the CREOLE study.
“In this study, attempting to address a significant clinical problem in an area of unmet need, we showed that [Humira (adalimumab, AbbVie)] treatment was successful in 64% of [Crohn’s disease] patients with symptomatic stricture at week 24,” investigators wrote. “Success was maintained in 29% of the whole cohort after a median follow-up time of nearly 4 years.”
Between January 2010 and December 2011, researchers performed a prospective, observational cohort study of 97 patients with Crohn’s disease and symptomatic small bowel stricture recruited from 20 centers in France, Belgium and Italy. All patients underwent magnetic resonance enterography (MRE) at baseline and were treated with adalimumab.
Treatment success at week 24 served as the primary endpoint, which researchers defined as continuation of adalimumab without corticosteroids, parenteral nutrition, other anti-TNFs, endoscopic dilation or bowel resection. The researchers also evaluated long-term outcomes, and developed a prognostic score based on independent predictors of success at baseline.
Overall, 62 of the 97 patients (64%) achieved the primary endpoint, 45.7% of them (29% of the total cohort) maintained successful response after a median follow-up of 3.8 years, and 50.7% of the total cohort did not require bowel resection at 4 years.
The prognostic factors that were independently associated with treatment success included use of immunosuppressive agents at the time adalimumab treatment began, obstructive symptoms for at least 5 weeks, a Crohn’s disease obstructive score greater than 4, and MRE factors including small bowel stricture length of less than 12 cm, maximal small bowel diameter proximal to strictures of 18 mm to 29 mm, marked enhancement on delayed phase, and absence of fistula.
Of the 49 patients defined as having a good prognosis, 88.1% achieved treatment success; of the 77 patients defined as having a good or intermediate prognosis, 77.7% achieved treatment success; and of the 16 patients defined as having a poor prognosis, 94.4% failed treatment.
“Based on these results, patients with a score of two points or fewer were considered to be unlikely to respond to adalimumab, while those with a score of four points or more were considered to be likely to respond to adalimumab,” the researchers wrote.
Serious adverse events occurred in 72% of patients.
The investigators concluded that adalimumab is an “efficient” treatment for these difficult to treat patients. – by Adam Leitenberger
Disclosures: The study was supported by a grant from AbbVie, and the researchers report various financial relationships with Bristol-Myers Squibb, Shire, Sanofi, Norgine Pharma, MSD, AbbVie, AstraZeneca, Roche, Takeda, Millenium, Janssen Cilag, Pfizer, Inception IBD, Teva, Ferring, Vifor Pharma, HAC and Myoli-Spindler.