Intrathecally administered natural human fibroblast interferon reduces exacerbations of multiple sclerosis. Results of a multicenter, double-blind study
L. Jacobs, A. M. Salazar, R. Herndon, P. A. Reese, A. Freeman, R. Jozefowicz, A. Cuetter, F. Husain, W. A. Smith, R. Ekes and al. et
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.
