Human immune globulin 10% with recombinant human hyaluronidase in multifocal motor neuropathy

Abstract

ObjectiveThe primary aim was to determine the safety of treatment with human immune globulin 10% with recombinant human hyaluronidase (fSCIg) compared to intravenous immunoglobulin (IVIg) in a prospective open-label study in patients with multifocal motor neuropathy (MMN).MethodsOur study consisted of two phases: the IVIg phase (visits 1–3; 12 weeks), in which patients remained on IVIg treatment, and the fSCIg phase (visits 4–7; 36 weeks), in which patients received fSCIg treatment. After visit 3, IVIg was switched to an equivalent dose and frequency of fSCIg. Outcome measures were safety, muscle strength, disability and treatment satisfaction.ResultsEighteen patients were enrolled in this study. Switching to fSCIg reduced the number of systemic adverse events (IVIg 11.6 vs. fSCIg 5.0 adverse events/per person-year, p < 0.02), and increased the number of local reactions at the injection site (IVIg 0 vs. fSCIg 3.3 local reactions/per person-year, p < 0.01). Overall, no significant differences in muscle strength and disability between fSCIg and IVIg were found. Treatment with fSCIg was perceived as optimal treatment option by 8 of the 17 patients (47.1%) and they continued with fSCIg after study closure because of improved independence and flexibility to administer treatment.ConclusionTreatment with fSCIg can be considered a safe alternative for patients with MMN on IVIg treatment. fSCIg could be a favorable option in patients who prefer self-treatment and more independency, and in patients who experience systemic adverse events on IVIg or have difficult intravenous access.Electronic supplementary materialThe online version of this article (10.1007/s00415-019-09475-x) contains supplementary material, which is available to authorized users.

Subcutaneous immunoglobulin treatment for chronic inflammatory demyelinating polyneuropathy

“…Data on long‐term safety and cost comparisons for fSCIg are lacking and there is limited evidence to suggest any differences in QoL between SCIg and fSCIg in either CIDP or other neuromuscular disorders. 75 , 76 , 77 …”

“…Data on long-term safety and cost comparisons for fSCIg are lacking and there is limited evidence to suggest any differences in QoL between SCIg and fSCIg in either CIDP or other neuromuscular disorders. [75][76][77] To date, the United States has the highest IgG usage per capita, followed by Canada, Australia, and some European countries. 78 Uptake of SCIg stands at 15% of total IgG use in the US market (of which currently 61% is used in PID).…”

“…fSCIg allows infusions at similar rates and volumes to IVIg, but with potential reductions in systemic AEs comparable with SCIg. Data on long‐term safety and cost comparisons for fSCIg are lacking and there is limited evidence to suggest any differences in QoL between SCIg and fSCIg in either CIDP or other neuromuscular disorders 75–77 …”