Health-related quality-of-life improvements in CIDP with immune globulin IV 10%: the ICE Study.
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.
Spaarne Hospital Hoofddorp, Spaarnepoort 1, 2134 TM Hoofddorp, The Netherlands. imerkies@spaarneziekenhuis.nl
I S J
IS
Merkies
V
V
Bril
M C
MC
Dalakas
C
C
Deng
P
P
Donofrio
K
K
Hanna
H-P
HP
Hartung
R A C
RA
Hughes
N
N
Latov
P A
PA
van Doorn
D000293:Adolescent; D000328:Adult; D018592:Cross-Over Studies; D004311:Double-Blind Method; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use*; D008603:Mental Health; D020277:Polyradiculoneuropathy, Chronic Inflammatory Demyelinating / Q000523:psychology* / Q000628:therapy*; D011788:Quality of Life; D012919:Social Behavior; D055815:Young Adult
D016756:Immunoglobulins, Intravenous