TY - JOUR
T1 - Ingested IFN-α
T2 - Results of a pilot study in relapsing-remitting MS
AU - Brod, Staley A.
AU - Lindsey, J. W.
AU - Vriesendorp, F. S.
AU - Ahn, C.
AU - Henninger, E.
AU - Narayana, P. A.
AU - Wolinsky, J. S.
PY - 2001/9/11
Y1 - 2001/9/11
N2 - 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.
AB - 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.
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U2 - 10.1212/WNL.57.5.845
DO - 10.1212/WNL.57.5.845
M3 - Article
C2 - 11552015
AN - SCOPUS:0035845612
SN - 0028-3878
VL - 57
SP - 845
EP - 852
JO - Neurology
JF - Neurology
IS - 5
ER -