Health-related quality-of-life improvements in CIDP with immune globulin IV 10%: The ICE Study

I. S J Merkies, V. Bril, M. C. Dalakas, C. Deng, P. Donofrio, K. Hanna, H. P. Hartung, R. A C Hughes, N. Latov, P. A. van Doorn, Fabio Barroso, Martin Nogués, Alberto Rivero, Cintia Marchesoni, Ana Maria Pardal, Ricardo Reisin, Alberto Dubrovsky, Andres Villa, Kristine Chapman, Gillian GibsonBlanka Adamova, Josef Bednarik, Stanislav Vohanka, Eduard Ehler, Judith Haas, Christoph Munch, Irina Artamonov, Vivian Drory, Galina Groozman, Aron Buchman, Joab Chapman, Antonino Uncini, Luana Benedetti, Elisabetta Ghiglione, Giovanni Mancardi, Eleonora Narciso, Angelo Schenone, Giancarlo Comi, Patrizia Dacci, Ubaldo Del Carro, Raffaella Fazio, Maria Chiara Malaguti, Nilo Riva, Jose Luis Ruiz-Sandoval, Waldemar Fryze, Andrzej Szczudlik, Marta Banach, Krzysztof Selmaj, Andrzej Bogucki, Malgorzata Zielinska, Zbigniew Stelmasiak, Halina Bartosik-Psujek, Ewa Belniak, Urszula Chyrchel, Marek Kaminski, Anna Kostera-Pruszczyk, Hubert Kwiecinski, Slobodan Apostolski, Ivana Basta, Vesna Divac, Rajko Trikic, Shin Oh, James Caress, Sungho Cho, Huned Patwa, Bryan Tsao, Florian Thomas, Jaya Trivedi, Gil Wolfe

Research output: Contribution to journalArticlepeer-review

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®]), 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® (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.

Original languageEnglish
Pages (from-to)1337-1344
Number of pages8
JournalNeurology
Volume72
Issue number15
DOIs
Publication statusPublished - Apr 14 2009

ASJC Scopus subject areas

  • Clinical Neurology

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