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| Research article summary (published 12 Apr 2009): |
Health-related quality-of-life improvements in CIDP with immune globulin IV 10%: the ICE Study.
Full Abstract
BACKGROUND: Chronic inflammatory demyelinating polyradiculoneuropathy trials have demonstrated the efficacy of IV immunoglobulin vs placebo. However, these trails have not addressed the long-term impact on health-related quality of life (HRQoL). METHODS: One hundred seventeen patients in a randomized, double-blind, response-conditional crossover trial received immune globulin IV, 10% caprylate/chromatography purified (IGIV-C [Gamunex(R)]), or placebo every 3 weeks for up to 24 weeks in the first period (FP). Participants whose inflammatory neuropathy cause and treatment disability score did not improve by >/=1 point received alternate treatment in a 24-week crossover period (CP). In either period, participants who improved and completed treatment were eligible to be randomly reassigned to a blinded 24-week extension phase (EP). HRQoL analyses were conducted using the Short Form-36(R) (SF-36) and the Rotterdam Handicap Scale (RHS). RESULTS: In the FP, greater improvements in both SF-36 physical and mental component scores were observed with IGIV-C vs placebo, with a significant improvement in the physical component score (difference 4.4 points; 95% confidence interval [CI] 0.7-8.0). Improvements in all SF-36 domains favored IGIV-C vs placebo, with physical functioning, role-physical, social functioning, and mental health reaching significance. Participants receiving IGIV-C experienced a larger improvement in RHS vs those receiving placebo (difference 3.4 points; 95% CI 1.4-5.5; p = 0.001). In the CP, similar general trends were observed. In the EP, mean SF-36 improvements were generally improved or maintained in participants who continued IGIV-C therapy; however, worsening was observed in participants re-randomized to placebo. CONCLUSIONS: Long-term therapy with immune globulin IV, 10% caprylate/chromatography purified, improves and maintains health-related quality of life in chronic inflammatory demyelinating polyradiculoneuropathy.
Author information
Author/s: Merkies, I S J (IS); Bril, V (V); Dalakas, M C (MC); Deng, C (C); Donofrio, P (P); Hanna, K (K); Hartung, H-P (HP); Hughes, R A C (RA); Latov, N (N); van Doorn, P A (PA); ICE Study Group;
Affiliation: Spaarne Hospital Hoofddorp, Spaarnepoort 1, 2134 TM Hoofddorp, The Netherlands. imerkies(-atsign-)spaarneziekenhuis.nl
Journal and publication information
Publication Type: Journal Article; Randomized Controlled Trial
Journal: Neurology (Neurology), published in United States. (Language: eng)
Reference: 2009-Apr; vol 72 (issue 15) : pp 1337-44
Dates: Created 2009/04/14; Completed 2009/05/01;
PMID: 19365055, status: MEDLINE (last retrieval date: 5/1/2009, IMS Date: )
Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.
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