Abstract | OBJECTIVE: METHODS: Adults with IV immunoglobulin ( IVIg)-dependent CIDP (n = 67) were enrolled in this 32-week double-blind trial and randomized to IM IFNbeta-1a. Patients received 30 microg once weekly plus placebo (n = 12), IM IFNbeta-1a 60 microg once weekly plus placebo (n = 11), IM IFNbeta-1a 30 microg twice weekly (n = 11), IM IFNbeta-1a 60 microg 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 IFNbeta-1a (1.20 g/kg) compared with placebo (1.34 g/kg; p = 0.75). However, exploratory analyses suggested IFNbeta-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 <51). Adverse events included flu-like symptoms, headache, and fatigue in the IFNbeta-1a groups. CONCLUSIONS: LEVEL OF EVIDENCE: This study was designed to provide Class I evidence for the safety and efficacy of IM IFNbeta-1a in the treatment of CIDP but has been subsequently classified as Class II due to a >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 IFNbeta-1a added to IVIg in persons with CIDP.
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Authors | R A C Hughes, K C Gorson, D Cros, J Griffin, J Pollard, J-M Vallat, S L Maurer, K Riester, G Davar, K Dawson, A Sandrock, Avonex CIDP Study Group |
Journal | Neurology
(Neurology)
Vol. 74
Issue 8
Pg. 651-7
(Feb 23 2010)
ISSN: 1526-632X [Electronic] United States |
PMID | 20177118
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Adjuvants, Immunologic
- Interferon-beta
- Interferon beta-1a
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Topics |
- Adjuvants, Immunologic
(administration & dosage, adverse effects)
- Adolescent
- Adult
- Aged
- Analysis of Variance
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Administration Schedule
- Fatigue
(chemically induced)
- Female
- Headache
(chemically induced)
- Humans
- Injections, Intramuscular
- Interferon beta-1a
- Interferon-beta
(administration & dosage, adverse effects)
- Kaplan-Meier Estimate
- Male
- Middle Aged
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
(drug therapy)
- Proportional Hazards Models
- Regression Analysis
- Treatment Outcome
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