A Randomised, Double-Blinded, Placebo Controlled Trial of the Effect of Subcutaneous Immunoglobulin on Muscular Performance in Chronic Inflammatory Demyelinating Polyneuropathy (P06.130)

Abstract

Objective: We hypothesised that the effect of subcutaneous infusion of immunoglobulins(SCIG) on muscular performance in chronic inflammatory demyelinating polyneuropathy(CIDP) is superior to that of placebo and equals the therapeutic effect of intravenous infusion(IVIG). Background Subcutaneous treatment with large amounts of immunoglobulins in multifocal motor neuropathy is feasible, safe and effective. In CIDP case reports indicate its therapeutic usefullness as well. Design/Methods: Subjects in IVIG maintenace therapy full-filling the EFNS/PNS criteria for CIDP were considered for participation. Exclusion criteria were pregnancy, malignancies, dementia, severe medical disorders and psychiatric disturbances. Thirty CIDP patients(n,30) characterized as IVIG-responders by their treating physicians were included in the study.Participants were randomised to receive either subcutaneous IgG at a concentration of 1.6g/10cc or subcutaneous saline in a double-blinded fashion. Infusions were given twice or thrice weekly for 12 weeks at home. The amount of immunoglobulin corresponded to the clinically predetermined dose. The first subcutaneous infusion was delivered two weeks after the last IVIG treatment. Participants were evaluated at four time intervals: - 2 wks, 0, 10 wks, 12 wks. Strength was determined at isokinetic dynamometry from four predetermined and weakened muscle groups. Also, an Overall Disability Sum Score (ODSS), a 40 meter walking test, a nine hole peg test, a Neurological Impairment Score (NIS), a Medical Research Council (MRC) score and a grip strength test were included. The primary end-point is the change of strength at isokinetic dynamometry in the two study groups. Secondary end-points are the treatment response of SCIG vs IVIG and the variation of the treatment response during SCIG vs IVIG. Results: The study ran during the period april 2010 to october 2011. Data will be presented. Conclusions: To be presented. Supported by: Aarhus University Hospital. A research grant from Baxter. Disclosure: Dr. Jakobsen has received research support from Baxter Medical AB. Dr. Markvardsen has nothing to disclose. Dr. Harbo has nothing to disclose. Dr. Sindrup has received personal compensation for activities with Grunenthal, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly & Company, and Pfizer Inc. Dr. Andersen has nothing to disclose. Dr. Christiansen has nothing to disclose. Dr. Olsen has nothing to disclose. Dr. Lassen has nothing to disclose.