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From the Mayo Clinic/Mayo Foundation, Rochester, MN.
Address correspondence and reprint requests to Dr. John H. Noseworthy, Department of Neurology, Mayo Clinic/Mayo Foundation, 200 First Street SW, Rochester, MN 55905.
Objective: To determine whether sulfasalazine is better than placebo in slowing disability progression in MS.
Methods: In this randomized, double-blind, placebo-controlled phase III trial, 199 patients with active relapsing-remitting (n = 151) or progressive (n = 48) MS were evaluated at 3-month intervals for a minimum of 3 years (94% completed 3 years of follow-up; mean follow-up, 3.7 years). MRI studies were performed at 6-month intervals on a subset of 89 patients.
Results: Sulfasalazine failed to slow or prevent disability progression as measured by the primary outcome (confirmed worsening of the Expanded Disability Status Scale [EDSS] score by at least 1.0 point on two consecutive 3-month visits). Sulfasalazine influenced favorably a number of secondary outcomes during the first 18 months of the trial (e.g., annualized relapse rate, proportion of relapse-free patients; progressive subgroup only: rate of EDSS progression at 1 and 2 years, median time to EDSS progression) but these positive findings were not sustained into the second half of the trial.
Conclusions: Sulfasalazine does not prevent EDSS score progression in the subset of MS patients studied by this protocol. Treatments may improve relapse-related outcomes in MS, at least temporarily, without providing sustained slowing of EDSS progression. Phase III MS trials should be of sufficient length to determine a meaningful impact on disease course.
*See the Appendix on page 1351 for a complete listing of investigators and their affiliations.
Supported by Pharmacia-Upjohn (Kalamazoo, MI) and the Mayo Clinic/Mayo Foundation (Rochester, MN).
Presented at the 49th annual meeting of the American Academy of Neurology; Boston, MA; April 1997.
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