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Subcutaneous immunoglobulin (SCIg) has been recently proposed as an effective alternative to intravenous immunoglobulin (IVIg) for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and multifocal motor neuropathy (MMN) treatment. The non-inferiority of SCIg over IVIg has been recently confirmed by a 4-month multicentre Italian observational study,1 where a similar efficacy was observed between the two therapies, with the SCIg showing possible advantages of stable plasmatic concentration2 and independence from hospital care. Here we report the 2-year experience of six Italian Neurological Centres, describing the long-term clinical outcomes of 66 patients (45 CIDP and 21 MMN) who were shifted from IVIg to SCIg.
All the CIDP and MMN patients treated with SCIg between 2009 and 2014 were considered, including patients with a previous documented response to IVIg (at least 6 months), and a wear-off effect between each IVIg infusion documented by a worsening of at least 1 point at the Overall Neuropathy Limitation Scale (ONLS).
Adherence to therapy was the primary outcome measure, while quality of life and clinical predictors of long-term disability were analysed as secondary outcomes. The clinical assessments were regularly performed by means of the ONLS, the Medical Research Council (MRC) scale in eight-muscle group bilaterally, and Life Quality Index (LQI). Clinical worsening was defined as increase of ≥1 ONLS point, requiring augmentation of SCIg dose, SCIg/IVIg combination therapy, or a return to IVIg for stabilising the clinical conditions. SCIg was administered at the patient's home, as previously described,1 converting the IVIg dose to an equivalent SCIg dose (20% solution of immunoglobulin ready-to-use) delivered via a programmable infusion pump. All patients signed a written informed consent, and ethical committee approval was obtained (CEI—629 Prot. n 0010675, 25 January 2013). Statistical analyses were carried out utilising the Wilcoxon, Mann-Whitney and Friedman non-parametric tests, Cox proportional hazard regression …