Ingested IFN-α: Results of a pilot study in relapsing-remitting MS

Staley A. Brod, J. W. Lindsey, F. S. Vriesendorp, C. Ahn, E. Henninger, P. A. Narayana, J. S. Wolinsky

Research output: Contribution to journalArticlepeer-review

26 Scopus citations

Abstract

Objective: To investigate whether ingested human recombinant interferon-α2a (IFN-α2a) 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-α2a 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-α protein secretion at months 4 and 5. Relapses and adverse events were not different among the treatment groups. Ingested IFN-α2a did not induce systemic anti-IFN-α 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-α may deserve further study.

Original languageEnglish (US)
Pages (from-to)845-852
Number of pages8
JournalNeurology
Volume57
Issue number5
DOIs
StatePublished - Sep 11 2001

ASJC Scopus subject areas

  • Clinical Neurology

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