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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 …
Contributors DC was involved in the organisation and execution of the research project; design, execution, review and critique of the statistical analysis; writing of the first draft and the review and critique of the manuscript. AM was involved in the execution of the research project; execution, review and critique of the statistical analysis; writing of the first draft and review and critique of the manuscript. AR was involved in the execution of the research project; execution, review and critique of the statistical analysis; review and critique of the manuscript. EP was involved in the execution of the research project; execution of the statistical analysis. AT, AM, LG, MR, RF, MF, GS, ES and EN-O were involved in the execution of the research project; review and critique of the manuscript. LL was guarantor; and involved in the conception and organisation of the research project; critique of the statistical analysis; and review and critique of the manuscript.
Competing interests DC received honoraria for lecturing from Baxter, CSL Behring, and Kedrion; he received personal compensation for serving on the Advisory Board of CSL Behring, Kedrion and Lilly and travel grants to attend scientific meetings from Baxter, Grifols, Kedrion, and CSL Behring. AT reports travel grants to attend scientific meetings from Kedrion, CSL Behring and Baxter. AM reports travel support for attending scientific meetings from CSL Behring—Italy and Kedrion—Italy. RF received personal compensation for serving on the Advisory Board of CSL Behring and Baxter, and travel grants from Baxter, Grifols, Kedrion and CLS Behring. GS received personal compensation for serving on the Advisory Board from Grunenthal, Baxter and Grifols. EN-O reports personal compensation for serving on the Advisory Board of CSL Behring, Baxter, Kedrion and Novartis; he received honoraria for lecturing, and travel grants to attend scientific meetings from Baxter, CSL Behring, Grifols and Kedrion. EP received travel grant to attend scientific meetings from CSL Behring.
Patient consent Obtained.
Ethics approval The authors declare that they acted in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement DC had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.