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Ingested IFN-alpha: results of a pilot study in relapsing-remitting MS
S A Brod1, J W Lindsey, F S Vriesendorp
1Department of Neurology, University of Texas-Houston, 77225, USA. Staley.A.Brod@uth.tmc.edu
Objective:
To investigate whether ingested human recombinant interferon-alpha2a (IFN-alpha2a) 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-alpha2a 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-alpha protein secretion at months 4 and 5. Relapses and adverse events were not different among the treatment groups. Ingested IFN-alpha2a did not induce systemic anti-IFN-alpha 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-alpha may deserve further study.
Insights
Ingested human recombinant interferon-alpha2a (IFN-alpha2a) did not significantly reduce MRI lesions in relapsing-remitting MS (RRMS). A lower dose showed a potential effect on immune markers and lesions, suggesting further study.
Area of Science:
- Neuroimmunology
- Gastroenterology
- Pharmacology
Background:
- Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system.
- Gadolinium-enhanced MRI lesions indicate active inflammation in relapsing-remitting MS (RRMS).
- Interferon-alpha (IFN-alpha) is an immunomodulatory cytokine with parenteral administration used in MS treatment.
Purpose of the Study:
- To assess the safety and efficacy of orally administered human recombinant interferon-alpha2a (IFN-alpha2a) in patients with active RRMS.
- To determine if ingested IFN-alpha2a reduces the number of gadolinium-enhanced lesions on serial MRI.
- To evaluate changes in immune markers and adverse events associated with oral IFN-alpha2a treatment.
Main Methods:
- A randomized, placebo-controlled trial involving 30 patients with active RRMS.
- Patients received placebo, 10,000 IU, or 30,000 IU of ingested IFN-alpha2a on alternate days for 9 months.
- Monthly clinical examinations and cerebral MRI with gadolinium contrast were performed.
Main Results:
- No significant reduction in gadolinium-enhanced lesions was observed based on the primary outcome measure.
- Post hoc analysis indicated a potential treatment effect in the 10,000 IU group, with 73% fewer lesions at month 5 compared to placebo (p < 0.05).
- Decreased tumor necrosis factor-alpha secretion was noted; no significant differences in relapses, adverse events, or anti-IFN-alpha antibodies were found.
Conclusions:
- Oral IFN-alpha2a did not demonstrate efficacy based on the primary MRI outcome in active RRMS.
- Observed changes in immune response and potential effects in the lower dose group warrant further investigation.
- Oral administration of IFN-alpha2a appears safe and does not induce anti-IFN antibodies.
