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 Gibson; Blanka 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

doi:10.1212/WNL.0b013e3181a0fd80

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

Neurology

Research output: Contribution to journal › Article › peer-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. © 2009 by AAN Enterprises, Inc.

Original language	English
Pages (from-to)	1337-1344
Number of pages	8
Journal	Neurology
Volume	72
Issue number	15
DOIs	https://doi.org/10.1212/WNL.0b013e3181a0fd80
State	Published - Apr 14 2009

ASJC Scopus Subject Areas

Clinical Neurology

Keywords

Cross-Over Studies
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating/psychology
Young Adult
Immunoglobulins, Intravenous/therapeutic use
Double-Blind Method
Social Behavior
Humans
Adolescent
Quality of Life
Adult
Mental Health

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Merkies, I. S. J., Bril, V., Dalakas, M. C., Deng, C., Donofrio, P., Hanna, K., Hartung, H. P., Hughes, R. A. C., Latov, N., van Doorn, P. A., Barroso, F., Nogués, M., Rivero, A., Marchesoni, C., Pardal, A. M., Reisin, R., Dubrovsky, A., Villa, A., Chapman, K., ... Wolfe, G. (2009). Health-related quality-of-life improvements in CIDP with immune globulin IV 10%: The ICE Study. Neurology, 72(15), 1337-1344. https://doi.org/10.1212/WNL.0b013e3181a0fd80

Merkies, ISJ, Bril, V, Dalakas, MC, Deng, C, Donofrio, P, Hanna, K, Hartung, HP, Hughes, RAC, Latov, N, van Doorn, PA, Barroso, F, Nogués, M, Rivero, A, Marchesoni, C, Pardal, AM, Reisin, R, Dubrovsky, A, Villa, A, Chapman, K, Gibson, G, Adamova, B, Bednarik, J, Vohanka, S, Ehler, E, Haas, J, Munch, C, Artamonov, I, Drory, V, Groozman, G, Buchman, A, Chapman, J, Uncini, A, Benedetti, L, Ghiglione, E, Mancardi, G, Narciso, E, Schenone, A, Comi, G, Dacci, P, Del Carro, U, Fazio, R, Malaguti, MC, Riva, N, Ruiz-Sandoval, JL, Fryze, W, Szczudlik, A, Banach, M, Selmaj, K, Bogucki, A, Zielinska, M, Stelmasiak, Z, Bartosik-Psujek, H, Belniak, E, Chyrchel, U, Kaminski, M, Kostera-Pruszczyk, A, Kwiecinski, H, Apostolski, S, Basta, I, Divac, V, Trikic, R, Oh, S, Caress, J, Cho, S, Patwa, H, Tsao, B, Thomas, F, Trivedi, J & Wolfe, G 2009, 'Health-related quality-of-life improvements in CIDP with immune globulin IV 10%: The ICE Study', Neurology, vol. 72, no. 15, pp. 1337-1344. https://doi.org/10.1212/WNL.0b013e3181a0fd80

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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{\textregistered}]), 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{\textregistered} (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. {\textcopyright} 2009 by AAN Enterprises, Inc.",

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note = "Neurology. 2009 Apr 14;72(15):1337-44. doi: 10.1212/WNL.0b013e3181a0fd80. Randomized Controlled Trial",

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day = "14",

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TY - JOUR

T1 - Health-related quality-of-life improvements in CIDP with immune globulin IV 10%

T2 - The ICE Study

AU - Merkies, I. S.J.

AU - Bril, V.

AU - Dalakas, M. C.

AU - Deng, C.

AU - Donofrio, P.

AU - Hanna, K.

AU - Hartung, H. P.

AU - Hughes, R. A.C.

AU - Latov, N.

AU - van Doorn, P. A.

AU - Barroso, Fabio

AU - Nogués, Martin

AU - Rivero, Alberto

AU - Marchesoni, Cintia

AU - Pardal, Ana Maria

AU - Reisin, Ricardo

AU - Dubrovsky, Alberto

AU - Villa, Andres

AU - Chapman, Kristine

AU - Gibson, Gillian

AU - Adamova, Blanka

AU - Bednarik, Josef

AU - Vohanka, Stanislav

AU - Ehler, Eduard

AU - Haas, Judith

AU - Munch, Christoph

AU - Artamonov, Irina

AU - Drory, Vivian

AU - Groozman, Galina

AU - Buchman, Aron

AU - Chapman, Joab

AU - Uncini, Antonino

AU - Benedetti, Luana

AU - Ghiglione, Elisabetta

AU - Mancardi, Giovanni

AU - Narciso, Eleonora

AU - Schenone, Angelo

AU - Comi, Giancarlo

AU - Dacci, Patrizia

AU - Del Carro, Ubaldo

AU - Fazio, Raffaella

AU - Malaguti, Maria Chiara

AU - Riva, Nilo

AU - Ruiz-Sandoval, Jose Luis

AU - Fryze, Waldemar

AU - Szczudlik, Andrzej

AU - Banach, Marta

AU - Selmaj, Krzysztof

AU - Bogucki, Andrzej

AU - Zielinska, Malgorzata

AU - Stelmasiak, Zbigniew

AU - Bartosik-Psujek, Halina

AU - Belniak, Ewa

AU - Chyrchel, Urszula

AU - Kaminski, Marek

AU - Kostera-Pruszczyk, Anna

AU - Kwiecinski, Hubert

AU - Apostolski, Slobodan

AU - Basta, Ivana

AU - Divac, Vesna

AU - Trikic, Rajko

AU - Oh, Shin

AU - Caress, James

AU - Cho, Sungho

AU - Patwa, Huned

AU - Tsao, Bryan

AU - Thomas, Florian

AU - Trivedi, Jaya

AU - Wolfe, Gil

N1 - Neurology. 2009 Apr 14;72(15):1337-44. doi: 10.1212/WNL.0b013e3181a0fd80. Randomized Controlled Trial

PY - 2009/4/14

Y1 - 2009/4/14

N2 - 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. © 2009 by AAN Enterprises, Inc.

AB - 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. © 2009 by AAN Enterprises, Inc.

KW - Cross-Over Studies

KW - Polyradiculoneuropathy, Chronic Inflammatory Demyelinating/psychology

KW - Young Adult

KW - Immunoglobulins, Intravenous/therapeutic use

KW - Double-Blind Method

KW - Social Behavior

KW - Humans

KW - Adolescent

KW - Quality of Life

KW - Adult

KW - Mental Health

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ER -

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

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