Neurology 2001;57:845-852
© 2001 American Academy of Neurology
Articles
Ingested IFN-
Results of a pilot study in relapsing-remitting MS
S. A. Brod, MD;,
J. W. Lindsey, MD;,
F. S. Vriesendorp, MD;,
C. Ahn, PhD;,
E. Henninger,
P. A. Narayana, PhD; and
J. S. Wolinsky, MD
From the Departments of Neurology (Drs. Brod, Lindsey, Vriesendorp, and Wolinsky, and Ms. Henninger), Internal Medicine (Dr. Ahn), and Radiology (Dr. Narayana), University of Texas–Houston.
Address correspondence and reprint requests to Dr. Staley A. Brod, University of Texas-Houston, Health Science Center, Department of Neurology, Suite 7.044, P.O. Box 20708, Houston, TX 77225; e-mail: Staley.A.Brod{at}uth.tmc.edu
Objective: — To investigate whether ingested human recombinant interferon- 2a (IFN-2a) was safe and whether treatment reduces the number of gadolinium-enhanced lesions on serial MRI in patients with active relapsing-remitting MS (RRMS).
Methods: — Entry criteria included clinically definite RRMS and one or more gadolinium-enhanced lesions on a screening MRI.
Results: — Of 80 patients screened, 33 were eligible and 30 patients were enrolled for treatment. Patients were randomized (10 per group) to placebo, 10,000 or 30,000 IU IFN-2a ingested on alternate days for 9 months. They were examined clinically and with monthly cerebral MRI. Sample size projections were based on the assumption of a parenteral IFN-like effect, a 90% reduction of enhancing lesions evident within 1 month of the initiation of treatment in the active treatment groups sustained during the 9-month study as the primary outcome variable.
Results: — There was no significant effect on enhancing lesions. However, post hoc analysis suggested a possible treatment effect in the 10,000 IU group. By direct monthly comparison of placebo and 10,000 IU group in treatment month 5, there were 73% (p < 0.05) fewer enhancements in the 10,000 IU group than in the placebo group. There was a decrease of tumor necrosis factor- protein secretion at months 4 and 5. Relapses and adverse events were not different among the treatment groups. Ingested IFN-2a did not induce systemic anti-IFN- antibodies.
Conclusions: — This trial showed no benefit based on the primary outcome measure. Because changes were detected in immune response and post hoc analysis suggested that a smaller dose could have an effect, IFN- may deserve further study.
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