Intramuscular interferon beta-1a in chronic inflammatory demyelinating polyradiculoneuropathy

TY - JOUR

T1 - Intramuscular interferon beta-1a in chronic inflammatory demyelinating polyradiculoneuropathy

AU - Hughes, R. A. C.

AU - Gorson, K. C.

AU - Cros, D.

AU - Griffin, J.

AU - Pollard, J.

AU - Vallat, J. -M.

AU - Maurer, S. L.

AU - Riester, K.

AU - Davar, G.

AU - Dawson, K.

AU - Sandrock, A.

PY - 2010/2

Y1 - 2010/2

N2 - Objective: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) shares immunologic features with multiple sclerosis (MS). Because IM interferon beta-1a (IM IFN beta-1a) is an effective and safe treatment for MS, we conducted a dose-ranging efficacy study of IFN beta-1a in patients with CIDP. Methods: Adults with IV immunoglobulin (IVIg)-dependent CIDP (n = 67) were enrolled in this 32-week double-blind trial and randomized to IM IFN beta-1a. Patients received 30 mu g once weekly plus placebo (n = 12), IM IFN beta-1a 60 mu g once weekly plus placebo (n = 11), IM IFN beta-1a 30 mu g twice weekly (n = 11), IM IFN beta-1a 60 mu g twice weekly (n = 11), or placebo twice weekly (n = 22). Participants were maintained on IVIg through week 16, when IVIg was discontinued. Patients who worsened were restarted on IVIg. The primary outcome was total IVIg dose (g/kg) administered from week 16 to 32. Results: There was no difference in total IVIg dose administered after week 16 for patients treated with IFN beta-1a (1.20 g/kg) compared with placebo (1.34 g/kg; p = 0.75). However, exploratory analyses suggested IFN beta-1a significantly reduced total dose of IVIg compared with placebo for participants who required either high-dose IVIg (>0.95 g/kg per month) or had greater weakness at baseline (Medical Research Council sum score 20% patient dropout rate. Thus, this randomized, controlled clinical trial provides Class II evidence of no effect on primary and secondary endpoints of 4 dosage regimens of IM IFN beta-1a added to IVIg in persons with CIDP. Neurology(R) 2010; 74: 651-657

AB - Objective: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) shares immunologic features with multiple sclerosis (MS). Because IM interferon beta-1a (IM IFN beta-1a) is an effective and safe treatment for MS, we conducted a dose-ranging efficacy study of IFN beta-1a in patients with CIDP. Methods: Adults with IV immunoglobulin (IVIg)-dependent CIDP (n = 67) were enrolled in this 32-week double-blind trial and randomized to IM IFN beta-1a. Patients received 30 mu g once weekly plus placebo (n = 12), IM IFN beta-1a 60 mu g once weekly plus placebo (n = 11), IM IFN beta-1a 30 mu g twice weekly (n = 11), IM IFN beta-1a 60 mu g twice weekly (n = 11), or placebo twice weekly (n = 22). Participants were maintained on IVIg through week 16, when IVIg was discontinued. Patients who worsened were restarted on IVIg. The primary outcome was total IVIg dose (g/kg) administered from week 16 to 32. Results: There was no difference in total IVIg dose administered after week 16 for patients treated with IFN beta-1a (1.20 g/kg) compared with placebo (1.34 g/kg; p = 0.75). However, exploratory analyses suggested IFN beta-1a significantly reduced total dose of IVIg compared with placebo for participants who required either high-dose IVIg (>0.95 g/kg per month) or had greater weakness at baseline (Medical Research Council sum score 20% patient dropout rate. Thus, this randomized, controlled clinical trial provides Class II evidence of no effect on primary and secondary endpoints of 4 dosage regimens of IM IFN beta-1a added to IVIg in persons with CIDP. Neurology(R) 2010; 74: 651-657

M3 - Article

SN - 1526-632X

VL - 74

SP - 651

EP - 657

JO - Neurology

JF - Neurology

IS - 8

ER -