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Daclizumab phase II trial in relapsing and remitting multiple sclerosis

MRI and clinical results

From the Neurovirology Research Laboratory (J.W.R., J.B.B., J.B., J.K., H.E.W., N.G.C.) and Geriatric Research Education Clinical Center (N.G.C.), Veterans Affairs Salt Lake City Health Care System, and Departments of Neurology (J.W.R, J.B.B., J.K., N.G.C.) and Neurobiology and Anatomy (N.G.C.) and Brain Institute (J.W.R., N.G.C.), University of Utah, Salt Lake City.

Address correspondence and reprint requests to Dr Rose, Neurovirology Research Laboratory, VA SLC HCS (151B), 500 Foothill Dr., Salt Lake City, UT 84148 jrose{at}genetics.utah.edu

Objective: Daclizumab is an interleukin 2 receptor chain specific humanized monoclonal antibody that has shown promising therapeutic effects in multiple sclerosis (MS). Daclizumab treatment in patients with relapsing and remitting MS was administered to determine effects on MRI and clinical outcomes.

Methods: Patients with MS on interferon (IFN) therapy but with continuing relapses and contrast enhancing lesions (CEL) were selected. Patients were evaluated with monthly MRI scans and clinical rating scales starting 3 months prior to treatment and then at 0.5 to 27.5 months during treatment. Daclizumab (1 mg/kg IV) was administered twice in the first month (initiated and administered again in 2 weeks), followed by treatments every 4 weeks. IFN was continued until 5.5 months after daclizumab was initiated. Patients were then placed on daclizumab monotherapy. Patients with recurrent CEL were restarted on IFN with daclizumab therapy at (1.5 mg/kg IV) every 28 days.

Results: Nine patients qualified for inclusion and completed the trial. Efficacy measured by both total CEL and new CEL (p < 0.001), relapses, timed ambulation, Expanded Disability Status Scale, and Neurologic Rating Scale (p < 0.05 to p < 0.01) was observed.

Conclusion: Daclizumab was effective in reducing contrast enhancing lesions and improving clinical scores in patients with relapsing and remitting multiple sclerosis with active disease not controlled by interferon therapy. These results provide evidence for long-term efficacy and support further clinical development of daclizumab.

Disclosure: The Cumming Foundation provided funding for the clinical trial. PDL Biopharma supplied the daclizumab. Dr. Roland Martin provided the treatment protocol.

Received November 15, 2006. Accepted in final form March 23, 2007.

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