By Andrew N. Wilner, MD
SALT LAKE CITY, Utah -- September 24, 2008 -- Patients with chronic inflammatory demyelinating polyneuropathy (CIDP) benefit from treatment with immune globulin intravenous 10% caprylate/chromatography purified (IGIV-C), according to research presented here at the American Neurological Association (ANA) 133rd Annual Meeting.
For their study, Ingemar S. J. Merkies, MD, Erasmus Medical Centre, Rotterdam, The Netherlands, and colleagues enrolled 117 patients aged 18 years or older with CIDP and progressive or relapsing motor and sensory dysfunction of at least 1 limb and clinical disability ranging from 2 to 9 on the Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale.
The study was divided into 2 phases: a randomised treatment phase (24 weeks) and a crossover extension phase (24 weeks). In the first phase, patients were randomised to treatment with IGIV-C (Gamunex) (n = 59) or placebo (n = 58). IGIV-C was administered as a loading dose of 2 g/kg over 2 to 4 days followed by 1g/kg over 1 to 2 days every 3 weeks for up to 24 weeks.
Results of the study, presented on September 22, show that patients treated with IGIV-C had a greater improvement on the physical component score of the Short Form-36 Quality of Life Scale (SF-36) compared with those treated with placebo (P = .020).
Physical functioning, role-physical, social functioning, and mental health also improved significantly with IGIV-C compared with placebo.
Treatment with IGIV-C also resulted in improvement from baseline on the Rotterdam Handicap Score (RHS), with an improvement in activities of daily living compared with placebo (P = .001).
Similar improvements were seen during the crossover phase. In the extension phase, the 31 patients who remained in IGIV-C arm generally continued to improve or stabilise. However, deterioration was observed on the SF-36 and RHS in the 26 patients who crossed over to the placebo arm.
Patients treated with IGIV-C for 48 weeks tended to improve their quality of life, the authors said.
They concluded that treatment with IGIV-C in patients with CIDP can have beneficial effects on quality of life, especially the physically oriented dimensions, and that mental health can also benefit. The authors recommended that IGIV-C be considered as first-line treatment for CIDP.
Funding for this study was provided by Talecris Biotherapeutics.
[Presentation title: Quality-of-Life (QoL) Improvements With Immune Globulin Intravenous, 10% Caprylate/Chromatography Purified (IGIV-C) in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Abstract M-3]
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