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Results of a Multicenter, Double-blinded Study

Lawrence Jacobs, MD; Andres M. Salazar, MD; Robert Herndon, MD; Peter A. Reese, JD; Arnold Freeman, MD; Ralph Jozefowicz, MD; Albert Cuetter, MD; Farhat Husain, MD; William A. Smith, MD; Roslyn Ekes; Judith A. O'Malley, PhD

Arch Neurol. 1987;44(6):589-595.

Abstract
• A randomized, double-blinded, placebo-controlled, two-year multicenter study demonstrated that natural human fibroblast interferon (interferon beta) administered intrathecally (IT) is effective in reducing the exacerbations of exacerbating-remitting multiple sclerosis (MS). The mean reduction in exacerbation rate of 34 patients with MS who received interferon beta administered IT was significantly greater during the study than that of 35 control patients who received placebo. The prestudy exacerbation rates were comparable for both patients who received interferon beta and control patients, but the exacerbation rate of patients receiving interferon beta at the end of the study was significantly lower than that of the control patients. Interferon beta was administered by nine or ten lumbar punctures for the first six months of the study, and observations were continued for two years. In 95% of the recipients, interferon beta therapy was well tolerated, and the side effects experienced were clearly acceptable for the benefits achieved. Low doses of indomethacin dramatically reduced the toxicity of interferon beta therapy and played an important role in successful double blinding. This study confirms a preliminary report on 20 patients that initially suggested that interferon beta administered IT was of benefit in patients with MS. The number of treatments was fewer and the dosage of interferon beta administered was less in the present study than in the preliminary one. It is possible that even fewer treatments with lower doses of interferon beta administered might provide a similar degree of prophylaxis against exacerbations.

Author Affiliations
From the Dent Neurologic Institute, Buffalo (Dr Jacobs and Ms Ekes); the Department of Neurology, State University of New York School of Medicine at Buffalo (Dr Jacobs); Vietnam Head Injury Study (Dr Salazar) and Neurology Department (Drs Cuetter, Husain, and Smith), Walter Reed Army Medical Center, Washington, DC; Department of Neurology, Uniformed Services University of the Health Sciences, Bethesda, Md (Dr Salazar); the Department of Neurology (Drs Herndon and Jozefowicz) and Center for Brain Research (Dr Herndon), University of Rochester (NY) Medical Center; the Departments of Biomathematics (Dr Reese), Pediatric Oncology (Dr Freeman), and Biological Resources (Dr O'Malley), Roswell Park Memorial Institute, Buffalo; and the Department of Microbiology, Roswell Park Division, State University of New York at Buffalo (Dr O'Malley).

Footnotes
Accepted for publication March 7, 1987.

Read in part at the Annual Meeting of the International Society for Interferon Research, Espoo, Finland, Sept 12, 1986, and at the Annual Meeting of the American Academy of Neurology, New York, April 7, 1987.

Reprint requests to Dent Neurologic Institute, Millard Fillmore Hospital, 3 Gates Circle, Buffalo, NY 14209 (Dr Jacobs).

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