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Title: Natalizumab Shows Potential in Treating Moderate-to-Severe Crohn's Disease: Presented at ACG

"Natalizumab Shows Potential in Treating Moderate-to-Severe Crohn's Disease: Presented at ACG"

By Paula Moyer LAS VEGAS, NV -- October 30, 2006 -- Natalizumab (Tysabri), a biologic agent approved for treatment of multiple sclerosis, may also have a role in the treatment of Crohn's disease, according to research presented here at the American College of Gastroenterology Annual Scientific Meeting (ACG). "We saw a significant benefit in patients with moderate-to-severe disease who also had elevated levels of C-reactive protein," said principal investigator Douglas Wolf, MD, medical director, Gastroenterology Associates, Atlanta, Georgia. In this presentation on October 23[^rd, Dr. Wolf compared the results of 2 studies of natalizumab in the treatment of moderate-to-severe Crohn's disease. In the first study, Evaluation of Natalizumab as Continuous Therapy (ENACT)-1, Dr. Wolf and colleagues evaluated the efficacy of 3 monthly natalizumab infusions of 300 mg for patients with moderate-to-severe Crohn's disease in 2 phase 3 trials with a total of 905 patients.

The study's findings were initially perplexing because there was an anomalous high placebo response. However, when the investigators assessed patients' C-reactive protein (CRP) levels, they found a higher response to treatment in patients with CRPs over 2.87 mg/L at baseline (49%) compared with 32% for those on placebo (P = .002). The remission rates were 29% for such patients on treatment and 19% for those on placebo (P = .041).

The investigators then conducted a follow-up study -- Efficacy of Natalizumab in Crohn's Disease Response and Remission (ENCORE) -- in which they recruited 509 patients with both moderate-to-severe disease and baseline CRPs over 2.87 mg/L.

Monthly treatment with natalizumab in the ENCORE cohort was associated with a response rate of 48% at both weeks 8 and 12, and 32% in the placebo group (P < .001). The remission rate at those points was 26% for treated patients and 16% for the placebo group (P = .002).

The findings showed "compelling evidence for natalizumab induction therapy in patients with Crohn's disease and evidence of systemic inflammation," Dr. Wolf said.

Tysabri is manufactured by Elan, which funded the study.

[Presentation title: Natalizumab Provides Consistent Induction Efficacy for Patients With Moderate to Severe Crohn's Disease and Elevated C-Reactive Protein: A Comparison of ENACT-1 and ENCORE. Abstract P706]

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