Elan Corp PLC (ELN): Tysabri Reduces Hospitalization in Crohn...

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Wednesday, 05/21/2008 8:10:55 PM

Wednesday, May 21, 2008 8:10:55 PM

Tysabri Reduces Hospitalization in Crohn's

(including in anti-TNF failures)

Natalizumab Reduces the Hospitalization Rate in Moderate to Severe Crohn’S Disease Patients: a Pooled Analysis of the ENACT-1 and ENCORE Studies

http://download.abstractcentral.com/ddw2008/myddw2008/1039.html

OBJECTIVE: To investigate the impact of natalizumab (NAT) treatment on the rate of hospitalization during induction.

BACKGROUND: While clinical trials in Crohn’s disease (CD) are generally designed to assess the benefit of treatments on disease markers, one of the major aims of treatment is to prevent adverse health outcomes such as hospitalization, a major contributor to the cost of CD care.

METHODS: The ENACT-1 and ENCORE trials randomized patients with moderate to severe CD (Crohn’s Disease Activity Index [CDAI] 220-450) to a 12-week induction period with intravenous infusions of NAT 300 mg or placebo (PBO) every 4 weeks. Data from both studies were combined and hospitalizations were identified from adverse event reports. Two independent experts, blinded to treatment allocation, identified the hospitalizations that were CD related. The rate of all-cause and CD-related hospitalizations (hospital admissions per 100 induction courses [/100IC]) over the induction period were analyzed using Poisson regression, correcting for study, potential confounders that were univariate predictors of hospitalization (CDAI, log C-reactive protein [CRP], body mass index), and time in study. Further analyses were performed in an a priori defined subpopulation (the “restricted population,” n=346) that had failed prior anti-TNF alpha therapy (ie, unresponsive, lost response, or intolerant) and had evidence of active inflammation (CRP >2.87 mg/L).

RESULTS: A total of 1,373 patients (of 1,414 available) had data on all covariates and comprised the analysis population (mean age 38 years, 58% female, hospitalizations=134). NAT was associated with a 34% reduction in the rate of all-cause hospitalization compared to PBO (7.3/100IC vs 11/100IC, P=0.026) and a comparable reduction (30%) in CD-related hospitalization (5.7/100IC vs 8.1/100IC, P=0.08). Prior TNF alpha use and active inflammation (log CRP) were significant predictors of hospitalization (P<0.001, P=0.003). The PBO rate in the restricted population was 2.5 times that in the remainder of the population (20.8/100IC vs 7.9/100IC). NAT-treated patients in the restricted population had all-cause hospitalization rates 47% (9.7/100IC vs 20.8/100IC, P=0.014) and CD-related hospitalization rates 49% those of their PBO-treated counterparts (6.3/100IC vs 12.8/100IC, P=0.04).

CONCLUSIONS: NAT was associated with a reduction in the rate of all-cause and CD-related hospitalizations compared to PBO-treated patients. This effect appeared to be greater in patients who had failed prior anti-TNF alpha therapy and had evidence of active inflammation. This patient subset was observed to have the highest hospitalization risk.

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