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

The ICE Study

From the Department of Neurology (I.S.J.M., P.A.v.D.), Erasmus MC, Rotterdam and Spaarne Hospital Hoofddorp, The Netherlands; University Health Network (V.B.), Toronto, Ontario, Canada; Neuromuscular Diseases Section (M.C.D.), National Institutes of Health, Bethesda, MD; Department of Neurology (P.D.), Vanderbilt University, Nashville, TN; Talecris Biotherapeutics, Inc. (C.D., K.H.), Research Triangle Park, NC; Department of Neurology (H.-P.H.), Heinrich Heine University, Düsseldorf, Germany; Department of Clinical Neuroscience (R.A.C.H.), King’s College London, Guy’s Hospital, London, UK; and Peripheral Neuropathy Center (N.L.), Cornell University, New York, NY.

Address correspondence and reprint requests to Dr. Ingemar S.J. Merkies, Spaarne Hospital Hoofddorp, Spaarnepoort 1, 2134 TM Hoofddorp, The Netherlands imerkies{at}spaarneziekenhuis.nl

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.

Abbreviations: CI = confidence interval; CIDP = chronic inflammatory demyelinating polyradiculoneuropathy; CP = crossover period; EP = extension phase; FP = first period; HRQoL = health-related quality of life; ICE = IGIV-C CIDP Efficacy; IGIV-C = immune globulin IV, 10% caprylate/chromatography purified; INCAT = inflammatory neuropathy cause and treatment; IVIg = IV immunoglobulin; LSM = least squares mean; RHS = Rotterdam Handicap Scale; SF-36 = Short Form-36®.

*Members of the ICE Study Group are listed in the acknowledgment.

Disclosures: Funding for the study was provided by Talecris Biotherapeutics, Center for Science and Education (Research Triangle Park, NC). I.S.J.M., V.B., M.C.D., P.D., H.-P.H., R.A.C.H., N.L., and P.A.v.D. received honoraria for participation on the ICE Study Steering Committee. H.-P.H. has received honoraria from Talecris Biotherapeutics for speaking at scientific symposia and for serving on a steering committee. C.D. and K.H. are employees of Talecris Biotherapeutics.

Received October 2, 2008. Accepted in final form February 2, 2009.

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