In 1981 we reported the results of an open, preliminary study of 20 patients suggesting that intrathecally (IT) administered natural human fibroblast interferon (IFN-B) reduced the neurologic exacerbations of patients with multiple sclerosis (MS).(1,2) We have subsequently conducted a randomized, double-blinded, placebo controlled, two-year, multicenter study to determine definitively whether this treatment is effective in MS.(3) The participating centers for the clinical aspects of the study were the Dent Neurologic Institute, Buffalo, N.Y.; Walter Reed Army Medical Center, Washington, D.C. and the University of Rochester Medical Center, Washington, D.C. The statistics center was the Department of Biomathematics, Roswell Park Memorial Institute, Buffalo, N.Y. Because of its potential importance, this study was monitored throughout its course by a committee of experts appointed by the National Institutes of Health.

Intrathecally Administered Natural Human Fibroblast Interferon Reduces Exacerbations of Multiple Sclerosis: 11:00 AM 3 L. Jacobs;A. Salazar;R. Herndon;P. Reese;A. Freeman;R. Josefowicz;A. Cuetter;F. Husain;W. Smith;R. Ekes;J. O'Malley; Neurology

In this randomised, double-blind, placebo-controlled, 2-year multicentre study intrathecally administered natural human fibroblast interferon (IFN-B) was effective in reducing exacerbations of multiple sclerosis (MS) in patients with exacerbating/remitting disease. The mean reduction in exacerbation rate of 34 patients who received IFN-B (recipients) was significantly greater during the study than that of 35 patients who received placebo (p less than 0.04). The prestudy exacerbation rates were comparable in recipients and controls, but the rate at the end of the study was significantly lower in recipients than in controls (p less than 0.001). IFN-B was given by nine or ten lumbar punctures over the first 6 months of the study, and patient observations continued for 2 years. IFN-B was well tolerated in 95% of the recipients, and the side-effects experienced were clearly acceptable for the benefits achieved. Low doses of indomethacin reduced the toxicity of IFN-B and played an important role in successful double-blinding.