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 journalArticle

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

Fingerprint

Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Quality Improvement
Immunoglobulins
Placebos
Quality of Life
Caprylates
Intravenous Immunoglobulins
Chromatography
Confidence Intervals
Therapeutics
Cross-Over Studies
Mental Health

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Merkies, I. S. J., Bril, V., Dalakas, M. C., Deng, C., Donofrio, P., Hanna, 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

Health-related quality-of-life improvements in CIDP with immune globulin IV 10% : The ICE Study. / 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, Fabio; Nogués, Martin; Rivero, Alberto; Marchesoni, Cintia; Pardal, Ana Maria; Reisin, Ricardo; Dubrovsky, Alberto; Villa, Andres; Chapman, Kristine; Gibson, Gillian; Adamova, Blanka; Bednarik, Josef; Vohanka, Stanislav; Ehler, Eduard; Haas, Judith; Munch, Christoph; Artamonov, Irina; Drory, Vivian; Groozman, Galina; Buchman, Aron; Chapman, Joab; Uncini, Antonino; Benedetti, Luana; Ghiglione, Elisabetta; Mancardi, Giovanni; Narciso, Eleonora; Schenone, Angelo; Comi, Giancarlo; Dacci, Patrizia; Del Carro, Ubaldo; Fazio, Raffaella; Malaguti, Maria Chiara; Riva, Nilo; Ruiz-Sandoval, Jose Luis; Fryze, Waldemar; Szczudlik, Andrzej; Banach, Marta; Selmaj, Krzysztof; Bogucki, Andrzej; Zielinska, Malgorzata; Stelmasiak, Zbigniew; Bartosik-Psujek, Halina; Belniak, Ewa; Chyrchel, Urszula; Kaminski, Marek; Kostera-Pruszczyk, Anna; Kwiecinski, Hubert; Apostolski, Slobodan; Basta, Ivana; Divac, Vesna; Trikic, Rajko; Oh, Shin; Caress, James; Cho, Sungho; Patwa, Huned; Tsao, Bryan; Thomas, Florian; Trivedi, Jaya; Wolfe, Gil.

In: Neurology, Vol. 72, No. 15, 14.04.2009, p. 1337-1344.

Research output: Contribution to journalArticle

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
Merkies ISJ, Bril V, Dalakas MC, Deng C, Donofrio P, Hanna K et al. Health-related quality-of-life improvements in CIDP with immune globulin IV 10%: The ICE Study. Neurology. 2009 Apr 14;72(15):1337-1344. https://doi.org/10.1212/WNL.0b013e3181a0fd80
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, Fabio ; Nogués, Martin ; Rivero, Alberto ; Marchesoni, Cintia ; Pardal, Ana Maria ; Reisin, Ricardo ; Dubrovsky, Alberto ; Villa, Andres ; Chapman, Kristine ; Gibson, Gillian ; Adamova, Blanka ; Bednarik, Josef ; Vohanka, Stanislav ; Ehler, Eduard ; Haas, Judith ; Munch, Christoph ; Artamonov, Irina ; Drory, Vivian ; Groozman, Galina ; Buchman, Aron ; Chapman, Joab ; Uncini, Antonino ; Benedetti, Luana ; Ghiglione, Elisabetta ; Mancardi, Giovanni ; Narciso, Eleonora ; Schenone, Angelo ; Comi, Giancarlo ; Dacci, Patrizia ; Del Carro, Ubaldo ; Fazio, Raffaella ; Malaguti, Maria Chiara ; Riva, Nilo ; Ruiz-Sandoval, Jose Luis ; Fryze, Waldemar ; Szczudlik, Andrzej ; Banach, Marta ; Selmaj, Krzysztof ; Bogucki, Andrzej ; Zielinska, Malgorzata ; Stelmasiak, Zbigniew ; Bartosik-Psujek, Halina ; Belniak, Ewa ; Chyrchel, Urszula ; Kaminski, Marek ; Kostera-Pruszczyk, Anna ; Kwiecinski, Hubert ; Apostolski, Slobodan ; Basta, Ivana ; Divac, Vesna ; Trikic, Rajko ; Oh, Shin ; Caress, James ; Cho, Sungho ; Patwa, Huned ; Tsao, Bryan ; Thomas, Florian ; Trivedi, Jaya ; Wolfe, Gil. / Health-related quality-of-life improvements in CIDP with immune globulin IV 10% : The ICE Study. In: Neurology. 2009 ; Vol. 72, No. 15. pp. 1337-1344.
@article{db8660a3ca144bf684911ef7f56d2e83,
title = "Health-related quality-of-life improvements in CIDP with immune globulin IV 10{\%}: The ICE Study",
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{\circledR}]), 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{\circledR} (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 = "Merkies, {I. S J} and V. Bril and Dalakas, {M. C.} and C. Deng and P. Donofrio and K. Hanna and Hartung, {H. P.} and Hughes, {R. A C} and N. Latov and {van Doorn}, {P. A.} and Fabio Barroso and Martin Nogu{\'e}s and Alberto Rivero and Cintia Marchesoni and Pardal, {Ana Maria} and Ricardo Reisin and Alberto Dubrovsky and Andres Villa and Kristine Chapman and Gillian Gibson and Blanka Adamova and Josef Bednarik and Stanislav Vohanka and Eduard Ehler and Judith Haas and Christoph Munch and Irina Artamonov and Vivian Drory and Galina Groozman and Aron Buchman and Joab Chapman and Antonino Uncini and Luana Benedetti and Elisabetta Ghiglione and Giovanni Mancardi and Eleonora Narciso and Angelo Schenone and Giancarlo Comi and Patrizia Dacci and {Del Carro}, Ubaldo and Raffaella Fazio and Malaguti, {Maria Chiara} and Nilo Riva and Ruiz-Sandoval, {Jose Luis} and Waldemar Fryze and Andrzej Szczudlik and Marta Banach and Krzysztof Selmaj and Andrzej Bogucki and Malgorzata Zielinska and Zbigniew Stelmasiak and Halina Bartosik-Psujek and Ewa Belniak and Urszula Chyrchel and Marek Kaminski and Anna Kostera-Pruszczyk and Hubert Kwiecinski and Slobodan Apostolski and Ivana Basta and Vesna Divac and Rajko Trikic and Shin Oh and James Caress and Sungho Cho and Huned Patwa and Bryan Tsao and Florian Thomas and Jaya Trivedi and Gil Wolfe",
year = "2009",
month = "4",
day = "14",
doi = "10.1212/WNL.0b013e3181a0fd80",
language = "English",
volume = "72",
pages = "1337--1344",
journal = "Neurology",
issn = "0028-3878",
publisher = "Lippincott Williams and Wilkins",
number = "15",

}

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

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.

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.

UR - http://www.scopus.com/inward/record.url?scp=65349156859&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=65349156859&partnerID=8YFLogxK

U2 - 10.1212/WNL.0b013e3181a0fd80

DO - 10.1212/WNL.0b013e3181a0fd80

M3 - Article

C2 - 19365055

AN - SCOPUS:65349156859

VL - 72

SP - 1337

EP - 1344

JO - Neurology

JF - Neurology

SN - 0028-3878

IS - 15

ER -