Immunoglobulin therapy facilitated by pretreatment with hyaluronidase (fSCIG) is feasible in the majority of patients with (MMN) previously treated with conventional infusion of multiple small dosages (cSCIG). Although it does increase short lasting local side effects as compared to cSCIG, fSCIG is effective for treatment of function, impairment, disability, and quality of life, and shows greater patient preference, according to a study published in the European Journal of Neurology.
This randomized, noninferiority, observer-blinded, 48-week, crossover study compared fSCIG with cSCIG in patients with MMN (N=20), with 24 weeks at each treatment. Due to the limited number of patients, researchers chose isometric muscle strength as the primary end point, as it has a high sensitivity for therapeutic effects compared with overall disability sum scores. Data for a range of functions, impairments, and disabilities were chosen as secondary endpoints. Patients were asked to compare the 2 therapies using 5 visual analog scale (VAS) scores for the following issues: easiness of administration of infusion, preference, maintenance of a normal life, side effects, and overall satisfaction. Blood was collected at the beginning of the study, after the final infusion in each treatment arm, and halfway through fSCIG treatment at days 1,7, and 14 after infusion, to determine IgG levels and to evaluate the presence of indicators of hemolytic anemia.
Two patients left the study due to side effects, making fSCIG feasible in 18 patients. Isometric strength was unchanged at 100.8% in fSCIG (95% CI, 94.8%-107.1%) and 105.9% in cSCIG (95% CI, 99.8%-112.0%), and no differences between the treatments were seen in the secondary end points of functions, disability, impairment, and quality of life. Short-lasting and mild generalized side effects were similar between both groups, although the relative frequency of localized side effects at the injection site was increased after fSCIG compared with cSCIG (0.63 [95% CI, 0.23-1.00) vs 0.09 [95% CI, 0.00-0.22]; P =.005). Patients preferred fSCIG for 2 out of the 5 VAS scores (maintaining a less disease–dominated lifestyle [P =.0001] and easiness of IgG administration [P =.006]), as well as in the total mean score for all preferences (P =.03).
Study investigators conclude that, “fSCIG therapy is feasible in the vast majority of MMN patients previously treated with cSCIG, that it increases local side-effects as compared to cSCIG, that it is effective for treatment of impairment, function, disability and quality of life and that patients favour pretreatment of IgG-infusion with hyaluronidase.”
This study was funded by a PhD study grant from Baxter/Baxalta, now part of Shire.
Ali-Zuhairy A, Jakobsen J, Andersen H, Sindrup SH, Markvardsen LK. Randomized trial of facilitated subcutaneous immunoglobulin in multifocal motor neuropathy [published online April 25, 2019]. Eur J Neurol. doi: 10.1111/ene.13978