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Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/222105
The Results of ADVANCE-CIDP IVIG Trial: Intravenous Immunoglobulin 10% Therapy With GAMMAGARD LIQUID Kiovig for Treatment of Relapse in Chronic Inflammatory Demyelinating Polyradiculoneuropathy
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Background ADVANCE-CIDP IVIG evaluated the efficacy and safety of immune globulin infusion (human) 10% solution (IVIG 10%; GAMMAGARD LIQUID, also known as Kiovig) in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) as a rescue treatment for patients relapsing during the ADVANCE-CIDP 1 trial.MethodsOpen-label ADVANCE-CIDP IVIG included adult patients with confirmed CIDP relapse (>= 1-point increase in adjusted Inflammatory Neuropathy Cause and Treatment [INCAT] disability scores from pre-treatment baseline) during ADVANCE-CIDP 1, which assessed the efficacy and safety of hyaluronidase-facilitated subcutaneous immunoglobulin (fSCIG) 10%. Patients received an induction IVIG 10% dose (2 g/kg) followed by maintenance infusions at the same monthly equivalent dose of pre-randomization IVIG, 3-weekly for 6 months. The primary outcome was the responder rate (>= 1-point decrease in adjusted INCAT scores at treatment cessation vs. pre-IVIG 10% baseline, in patients receiving placebo in ADVANCE-CIDP 1). Other outcomes included the responder rate across all patients relapsing on fSCIG 10% or placebo in ADVANCE-CIDP 1, time to functional improvement (>= 1-point decrease in adjusted INCAT score), and change in adjusted INCAT scores and Rasch-built Overall Disability Scale (R-ODS) centile scores from pre-IVIG 10% baseline.ResultsOverall, 20 patients received IVIG 10% (n = 4 [fSCIG 10%-relapse group]; n = 16 [placebo-relapse group]). Responder rate (95% confidence interval) was 100.0% (80.6%-100.0%) in the placebo-relapse group and 95.0% (76.4%-99.1%) in the overall-relapse population. Across all patients, median time to functional improvement was 25 days. At treatment cessation, mean changes from pre-IVIG 10% baseline in adjusted INCAT and R-ODS centile scores were -1.9 and 12.9, respectively.ConclusionsIVIG 10% effectively treated CIDP relapse and improved functional abilities.
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PASNOOR, Mamatha, ANDERSON SMITS, Colin, LEVINE, Todd, BRIL, Vera, MARCOS SOLANO, Juan, REJDAK, Konrad, GAMEZ, Josep, CHRONI, Elisabeth, CASASNOVAS, Carlos, MARCHIONI, Enrico, SICILIANO, Gabriele, COCITO, Dario, SIVAKUMAR, K., RIVERO, Alberto, DUFF, Kim, GRECO, Erin, CORBO, Massimo, HASAN, Shabbir, DORI, Amir, SCHMIDT, Jens, WOOD, Jamie, LI, Zhaoyang, AY, Hakan. The Results of ADVANCE-CIDP IVIG Trial: Intravenous Immunoglobulin 10% Therapy With GAMMAGARD LIQUID Kiovig for Treatment of Relapse in Chronic Inflammatory Demyelinating Polyradiculoneuropathy. _European Journal of Neurology_. 2025. Vol. 32, núm. 4, pàgs. e70110. [consulta: 23 de gener de 2026]. ISSN: 1468-1331. [Disponible a: https://hdl.handle.net/2445/222105]