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GLANCE

Results of a phase 2, randomized, double-blind, placebo-controlled study

From the University of Rochester Medical Center (A.D.G.), Rochester, NY; Michigan Institute for Neurological Disorders (H.R.), Farmington Hills, MI; Montreal Neurological Institute (A.B.-O.), Montreal, Quebec, Canada; Mount Sinai School of Medicine (A.M., F.L.), New York, NY; Institute of Neurology (D.H.M., K.S.), University College London, UK; Wayne State University School of Medicine (O.K.), Detroit, MI; and Biogen Idec, Inc. (N.M.B., M.Y., M.A.P., A.W.S.), Cambridge, MA.

Address correspondence and reprint requests to Dr. Andrew D. Goodman, Department of Neurology, University of Rochester Medical Center, 601 Elmwood Ave., Rochester, NY 14642 andrew_goodman{at}urmc.rochester.edu

Objective: To evaluate the safety and tolerability of natalizumab when added to glatiramer acetate (GA) in patients with relapsing multiple sclerosis. The primary outcome assessed whether this combination would increase the rate of development of new active lesions on cranial MRI scans vs GA alone.

Methods: This phase 2, randomized, double-blind, placebo-controlled study included patients aged 19 to 55 years who were treated with GA for at least 1 year before randomization and experienced at least one relapse during the previous year. Patients received IV natalizumab 300 mg (n = 55) or placebo (n = 55) once every 4 weeks plus GA 20 mg subcutaneously once daily for 20 weeks.

Results: The mean rate of development of new active lesions was 0.03 with combination therapy vs 0.11 with GA alone (p = 0.031). Combination therapy resulted in lower mean numbers of new gadolinium-enhancing lesions (0.6 vs 2.3 for GA alone, p = 0.020) and new/newly enlarging T2-hyperintense lesions (0.5 vs 1.3, p = 0.029). The incidence of infection and infusion reactions was similar in both groups; no hypersensitivity reactions were observed. One serious adverse event occurred with combination therapy (elective hip surgery). With the exception of an increase in anti-natalizumab antibodies with combination therapy, laboratory data were consistent with previous clinical studies of natalizumab alone.

Conclusion: The combination of natalizumab and glatiramer acetate seemed safe and well tolerated during 6 months of therapy.

Abbreviations: AE = adverse event; CONSORT = Consolidated Standards of Reporting Trials; EDSS = Expanded Disability Status Scale; GA = glatiramer acetate; Gd⁺ = gadolinium-enhancing; GLANCE = Glatiramer Acetate and Natalizumab Combination Evaluation; IFNβ = interferon β; MS = multiple sclerosis; PML = progressive multifocal leukoencephalopathy.

*GLANCE study investigators are listed in the appendix.

The MS NMR Research Unit in London is supported by the MS Society of Great Britain and Northern Ireland. K.S. is supported by the WellcomeTrust.

Disclosure: Author disclosures are provided at the end of the article.

Received June 4, 2008. Accepted in final form December 9, 2008.

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