TY - JOUR
T1 - Subcutaneous immunoglobulin in responders to intravenous therapy with chronic inflammatory demyelinating polyradiculoneuropathy
AU - Markvardsen, L. H.
AU - Debost, J. C.
AU - Harbo, Thomas
AU - Sindrup, Søren Hein
AU - Andersen, H.
AU - Christiansen, I.
AU - Otto, M.
AU - Olsen, Niels Kjær
AU - Lassen, L. L.
AU - Jakobsen, J.
AU - The Danish CIDP and MMN Study Group
PY - 2013/5/1
Y1 - 2013/5/1
N2 - Background and purpose: We hypothesized that subcutaneous administration of immunoglobulins (SCIG) in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is feasible, safe and superior to treatment with saline for the performance of muscle strength. Methods: Thirty patients with motor involvement in maintenance therapy with intravenous immunoglobulin (IVIG) fulfilling the EFNS/PNS criteria for CIDP, aged 18-80years, were randomized either to SCIG at a dose corresponding to their pre-study IVIG dose or to subcutaneous saline given twice or thrice weekly for 12weeks at home. At the start and end of the trial as well as 2weeks before (-2, 0, 10, 12weeks), isokinetic strength performance of four predetermined and weakened muscle groups was measured. Also, an Overall Disability Sum Score (ODSS), 40-m-walking test (40-MWT), nine-hole-peg test, Neurological Impairment Score (NIS), Medical Research Council (MRC) score, grip strength, standardized electrophysiological recordings from three nerves, and plasma IgG levels were evaluated. Results: SCIG treatment was well tolerated in all 14 patients. Six patients complained of mild side-effects at the injection site. In the SCIG group there was an increase of isokinetic muscle strength of 5.5±9.5% (P<0.05) as compared with a decline of 14.4±20.3% (P<0.05) in the placebo group; the difference between the two groups being significant (P<0.01). ODSS, NIS, MRC, grip strength and 40-MWT improved following SCIG versus saline. Conclusions: SCIG treatment in CIDP is feasible, safe and effective, and seems an attractive alternative to IVIG.
AB - Background and purpose: We hypothesized that subcutaneous administration of immunoglobulins (SCIG) in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is feasible, safe and superior to treatment with saline for the performance of muscle strength. Methods: Thirty patients with motor involvement in maintenance therapy with intravenous immunoglobulin (IVIG) fulfilling the EFNS/PNS criteria for CIDP, aged 18-80years, were randomized either to SCIG at a dose corresponding to their pre-study IVIG dose or to subcutaneous saline given twice or thrice weekly for 12weeks at home. At the start and end of the trial as well as 2weeks before (-2, 0, 10, 12weeks), isokinetic strength performance of four predetermined and weakened muscle groups was measured. Also, an Overall Disability Sum Score (ODSS), 40-m-walking test (40-MWT), nine-hole-peg test, Neurological Impairment Score (NIS), Medical Research Council (MRC) score, grip strength, standardized electrophysiological recordings from three nerves, and plasma IgG levels were evaluated. Results: SCIG treatment was well tolerated in all 14 patients. Six patients complained of mild side-effects at the injection site. In the SCIG group there was an increase of isokinetic muscle strength of 5.5±9.5% (P<0.05) as compared with a decline of 14.4±20.3% (P<0.05) in the placebo group; the difference between the two groups being significant (P<0.01). ODSS, NIS, MRC, grip strength and 40-MWT improved following SCIG versus saline. Conclusions: SCIG treatment in CIDP is feasible, safe and effective, and seems an attractive alternative to IVIG.
KW - Chronic inflammatory demyelinating polyradiculoneuropathy
KW - Pharmacology
KW - Subcutaneous immunoglobulin
U2 - 10.1111/ene.12080
DO - 10.1111/ene.12080
M3 - Journal article
C2 - 23294032
AN - SCOPUS:84876334249
SN - 1351-5101
VL - 20
SP - 836
EP - 842
JO - European Journal of Neurology
JF - European Journal of Neurology
IS - 5
ER -