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. 2003 Oct 28;328(8521):1411–1413. doi: 10.1016/S0140-6736(86)92730-3

MULTICENTRE DOUBLE-BLIND STUDY OF EFFECT OF INTRATHECALLY ADMINISTERED NATURAL HUMAN FIBROBLAST INTERFERON ON EXACERBATIONS OF MULTIPLE SCLEROSIS

Lawrence Jacobs a, Robert Herndon d, Arnold Freeman e, Albert Cuetter b, WilliamA Smith b, AndresM Salazar b,c, PeterA Reese e, Ralph Josefowicz d, Farhat Husain b, Roslyn Ekes a, JudithA O'Malley e
PMCID: PMC7134842  PMID: 2878272

Abstract

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 <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 <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.

Footnotes

Presented in part at the annual meeting of the International Society for Interferon Research, Espoo, Finland, on Sept 12, 1986.

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