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Identifying and treating patients with suboptimal responses

From the Davee Department of Neurology, Northwestern University, Chicago, Illinois (Dr. Cohen); Wayne State University, Detroit, Michigan (Dr. Khan); Wake Forest University, Winston-Salem, North Carolina (Dr. Jeffery); University of Alabama, Birmingham, Alabama (Dr. K. Bashir); Brown University, Providence, Rhode Island (Dr. Rizvi); Multiple Sclerosis Clinic of Central Texas, Austin, Texas (Dr. Fox); University of California at Davis, Davis, California (Dr. Agius); Creighton University, Omaha, Nebraska (Dr. R. Bashir); MS Center at Maine Neurology, Scarborough, Maine (Dr. Collins); University of Mississippi, Jackson, Mississippi (Dr. Herndon); Roslyn Ekes Multiple Sclerosis Clinic, Buffalo, New York (Dr. Kinkel); Department of Neurology, University of Michigan, Ann Arbor, Michigan (Dr. Mikol); Gimbel Multiple Sclerosis Center, Teaneck, New Jersey (Dr. Picone); Baylor College of Medicine, Houston, Texas (Dr. Rivera); Georgetown University, Washington, DC (Dr. Tornatore); and Doctors’ Hospital, Coral Gables, Florida (Dr. Zwibel).

Address correspondence and reprint requests to Dr.Bruce A. Cohen, Northwestern University, Davee Department of Neurology, 710 North Lake Shore Drive, Abbott Hall 1121, Chicago, IL 60611; e-mail: bac106{at}northwestern.edu

Multiple sclerosis (MS) is an immune-mediated neurologic disease in which acute inflammatory events early in the disease course contribute to subsequent neurologic disability. The early relapsing inflammatory phase is followed by a progressive degenerative phase in which the frequency of acute inflammatory attacks diminishes but progressive loss of neurologic function continues. Current immune therapies are most effective in suppressing the acute inflammatory events that characterize the earlier stages of disease. Optimal suppression of these inflammatory events is likely to have the best potential for delaying or preventing loss of axons and decline in neurologic function. In view of these considerations, and because MS is a heterogeneous disease and response to disease-modifying agents (DMA) varies across individuals, it is important to identify suboptimal responders as early as possible to allow therapeutic modification while the opportunity to avert future loss of function remains. At present, no criteria for identifying suboptimal responders have been validated. In January 2004, a group of neurologists from 16 MS centers in the United States met to develop a consensus on criteria for defining suboptimal response for use in compelling clinical situations and to prompt clinical studies to validate the efficacy of these criteria. Consensus criteria included relapse rates of either 1/year or unchanged from pretreatment rates, incomplete recovery from multiple attacks, evolution of polyregional neurologic involvement, recurrent brainstem or spinal cord lesions, and cumulative loss of neurologic function sufficient to disrupt daily activities. The panel then considered the use of mitoxantrone for patients with worsening MS and a suboptimal response to DMA therapy.

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