Elan reports encouraging subset data from Phase III Crohn's disease trials

Oct 28, 2009 (Datamonitor via COMTEX) -- BIIB | Quote | Chart | News | PowerRating -- Irish biotechnology company Elan and and US-based Biogen Idec have reported data showing that treatment with Tysabri significantly reduced the rate of hospitalization compared with placebo in patients with moderate-to-severe Crohn's disease during both induction and maintenance treatment. These results were obtained from retrospective subset analyses of three registrational Phase III trials, Enact-1, Enact-2 and Encore, and one open-label study.

The retrospective subset analysis evaluated the effect of Tysabri on the rate of hospitalization during induction and maintenance treatment using pooled data from the Enact-1 and Encore trials. In those trials, patients with Crohn's disease were randomized to intravenous Tysabri 300mg or placebo every four weeks for three doses. The maintenance analysis was conducted on Tysabri responders in Enact-1 who were re-randomized and followed for an additional 48 weeks of therapy in Enact-2.

Data on patients losing response in Enact-2 who rolled over to an open-label study (Enable) supplemented the Enact-2 data. Rates of all-cause hospitalization and Crohn's disease-related hospitalization per 100 patients over the 84-day induction period and the 336-day maintenance periods were evaluated.

According to Elan, results of the subset analysis showed that hospitalization rates were significantly lower in patients treated with Tysabri when compared with placebo. Two physicians, blinded to treatment, reviewed all data to determine hospitalizations and surgeries and whether they were, or were not, related to Crohn's disease.

Out of the approximately 1500 patients involved in these trials, the total number of all-cause hospitalizations was (n=136). In those patients treated with Tysabri, the rate of all-cause hospitalizations was reduced by 35% (p=0.009) during the induction period and 44% (p=0.044) during the maintenance period. The total number of Crohn's disease-related hospitalizations was (n=109). In these Tysabri-treated patients, the rate was reduced by 31% (p<0.001) during the induction period and 58% (p=0.027) during the maintenance period.

In patients who had received prior anti-tumor necrosis factor (TNF) therapy, a more difficult-to-treat patient population, the benefit of Tysabri was higher. During the induction period, the total number of all-cause hospitalizations was (n=57). In these patients, the rate was reduced by 56% (p=0.031) and Crohn's disease-related hospitalization (n=46) the rate was reduced by 55% (p=0.052). During the maintenance period, all-cause hospitalization rate was reduced by 60% (p=0.034) and the Crohn's disease-related hospitalization rate was reduced by 75% (p=0.029), the company added.

Carlos Paya, president of Elan, said: "The results of this analysis showing reduced hospitalization rates, together with subset data, provide additional support that Tysabri is an important treatment option for patients with this chronic and debilitating disease who have failed anti-TNF alpha therapies."

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