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Hyaluronidase-facilitated subcutaneous immunoglobulin 10% as maintenance therapy for chronic inflammatory demyelinating polyradiculoneuropathy: The ADVANCE-CIDP 1 randomized controlled trial

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dc.contributor.author Bril, Vera
dc.contributor.author Hadden, Robert D.M.
dc.contributor.author Brannagan, Thomas H.
dc.contributor.author Bar, Michal
dc.contributor.author Chroni, Elisabeth
dc.contributor.author Rejdak, Konrad
dc.contributor.author Rivero, Alberto Daniel
dc.contributor.author Andersen, Henning
dc.contributor.author Latov, Norman
dc.contributor.author Levine, Todd
dc.contributor.author Pasnoor, Mamatha
dc.contributor.author Sacconi, Sabrina
dc.contributor.author Souayah, Nizar
dc.contributor.author Anderson-Smits, Colin
dc.contributor.author Duff, Kim
dc.contributor.author Greco, Erin
dc.contributor.author Hasan, Shabbir
dc.contributor.author Li, Zhaoyang
dc.contributor.author Yel, Leman
dc.contributor.author Ay, Hakan
dc.date.accessioned 2023-12-19T14:35:49Z
dc.date.available 2023-12-19T14:35:49Z
dc.date.issued 2023-07-06
dc.identifier.citation Bril V, Hadden RDM, Brannagan TH 3rd, Bar M, Chroni E, Rejdak K, Rivero A, Andersen H, Latov N, Levine T, Pasnoor M, Sacconi S, Souayah N, Anderson-Smits C, Duff K, Greco E, Hasan S, Li Z, Yel L, Ay H. Hyaluronidase-facilitated subcutaneous immunoglobulin 10% as maintenance therapy for chronic inflammatory demyelinating polyradiculoneuropathy: The ADVANCE-CIDP 1 randomized controlled trial. J Peripher Nerv Syst. 2023 Sep;28(3):436-449. doi: 10.1111/jns.12573 es_ES
dc.identifier.uri https://doi.org/10.1111/jns.12573
dc.identifier.uri https://repositorio.fleni.org.ar/xmlui/handle/123456789/921
dc.description.abstract Background and aims: ADVANCE-CIDP 1 evaluated facilitated subcutaneous immunoglobulin (fSCIG; human immunoglobulin G 10% with recombinant human hyaluronidase) efficacy and safety in preventing chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) relapse. Methods: ADVANCE-CIDP 1 was a phase 3, double-blind, placebo-controlled trial conducted at 54 sites in 21 countries. Eligible adults had definite or probable CIDP and adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability scores of 0-7 (inclusive), and received stable intravenous immunoglobulin (IVIG) for ≥12 weeks before screening. After stopping IVIG, patients were randomized 1:1 to fSCIG 10% or placebo for 6 months or until relapse/discontinuation. fSCIG 10% was administered at the same dose (or matching placebo volume) and interval as pre-randomization IVIG. The primary outcome was patient proportion experiencing CIDP relapse (≥1-point increase in adjusted INCAT score from pre-subcutaneous treatment baseline) in the modified intention-to-treat population. Secondary outcomes included time to relapse and safety endpoints. Results: Overall, 132 patients (mean age 54.4 years, 56.1% male) received fSCIG 10% (n = 62) or placebo (n = 70). CIDP relapse was reduced with fSCIG 10% versus placebo (n = 6 [9.7%; 95% confidence interval 4.5%, 19.6%] vs n = 22 [31.4%; 21.8%, 43.0%], respectively; absolute difference: -21.8% [-34.5%, -7.9%], p = .0045). Relapse probability was higher with placebo versus fSCIG 10% over time (p = .002). Adverse events (AEs) were more frequent with fSCIG 10% (79.0% of patients) than placebo (57.1%), but severe (1.6% vs 8.6%) and serious AEs (3.2% vs 7.1%) were less common. Interpretation: fSCIG 10% more effectively prevented CIDP relapse than placebo, supporting its potential use as maintenance CIDP treatment. es_ES
dc.language.iso eng es_ES
dc.publisher Wiley es_ES
dc.rights info:eu-repo/semantics/openAccess
dc.subject Hyaluronoglucosaminidase es_ES
dc.subject Hialuronoglucosaminidasa es_ES
dc.subject Immunoglobulins, Intravenous es_ES
dc.subject Inmunoglobulinas Intravenosas es_ES
dc.subject Neoplasm Recurrence, Local es_ES
dc.subject Recurrencia Local de Neoplasia es_ES
dc.subject Polyradiculoneuropathy, Chronic Inflammatory Demyelinating es_ES
dc.subject Polirradiculoneuropatía Crónica Inflamatoria Desmielinizante es_ES
dc.title Hyaluronidase-facilitated subcutaneous immunoglobulin 10% as maintenance therapy for chronic inflammatory demyelinating polyradiculoneuropathy: The ADVANCE-CIDP 1 randomized controlled trial es_ES
dc.type info:eu-repo/semantics/article es_ES
dc.type info:eu-repo/semantics/publishedVersion
dc.description.fil Fil: Rivero, Alberto Daniel. Fleni. Departamento de Neurología. Servicio de Neurofisiología; Argentina.
dc.relation.ispartofVOLUME 28
dc.relation.ispartofNUMBER 3
dc.relation.ispartofPAGINATION 436-449
dc.relation.ispartofCOUNTRY Estados Unidos
dc.relation.ispartofCITY Hoboken
dc.relation.ispartofTITLE Journal of the peripheral nervous system
dc.relation.ispartofISSN 1529-8027
dc.type.snrd info:ar-repo/semantics/artículo es_ES


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