Subcutaneous immunoglobulin (SCIG) for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (CIDP), a multicenter randomized double-blind placebo-controlled trial: The PATH Study
| Autor: | D. Cocito, E. Peci, G. Lauria Pinter, P. Dacci, A. Di Muzio, R. Telese, A. Schenone, L. Benedetti, G. Antonini, S. Morino, S. Sorbi, S. Matà, V. Bril, N. van Geloven, H.-P. Hartung, R.A. Lewis, G. Sobue, J.-P. Lawo, O. Mielke, B.L. Durn, D.R. Cornblath, I.S.J. Merkies, I.N. van Schaik |
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| Rok vydání: | 2019 |
| Předmět: |
medicine.medical_specialty
business.industry Placebo-controlled study Chronic inflammatory demyelinating polyneuropathy Subcutaneous immunoglobulin medicine.disease Placebo Sensory Systems Double blind Safety profile Primary outcome Neurology Physiology (medical) Internal medicine Medicine Neurology (clinical) business |
| Zdroj: | Clinical Neurophysiology. 130:e10 |
| ISSN: | 1388-2457 |
| DOI: | 10.1016/j.clinph.2018.09.067 |
| Popis: | Several CIDP patients need long-term corticosteroids or intravenous immunoglobulin (IVIG), with IVIG being associated with improved safety profile. SCIG is an alternative option for immunoglobulin delivery but it was not investigated in large-scale trials in CIDP. PATH was a randomized, double-blind trial investigating 0.2 and 0.4 g/kg weekly doses of SCIG IgPro20 (Hizentra®, CSL Behring) versus placebo for maintenance treatment in 172 CIDP patients. IVIG-dependent adults with definite or probable CIDP were eligible. The primary outcome was the percentage of subjects with a CIDP relapse (1-point deterioration on adjusted INCAT disability score) or who were withdrawn for any reason during the 24-week SCIg-treatment. Multiple secondary endpoints were assessed. Overall, 33% of patients on high-dose SCIG, 39% of those on low-dose SCIG and 63% of placebo recipients experienced CIDP relapse or were withdrawn from treatment (p |
| Databáze: | OpenAIRE |
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