Pasnoor, MamathaAnderson Smits, ColinLevine, ToddBril, VeraMarcos Solano, JuanRejdak, KonradGamez, JosepChroni, ElisabethCasasnovas, CarlosMarchioni, EnricoSiciliano, GabrieleCocito, DarioSivakumar, K.Rivero, AlbertoDuff, KimGreco, ErinCorbo, MassimoHasan, ShabbirDori, AmirSchmidt, JensWood, JamieLi, ZhaoyangAy, Hakan2025-07-082025-07-082025-04-011468-1331https://hdl.handle.net/2445/222105Background 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.11 p.application/pdfengcc by-nc (c) Pasnoor, Mamatha et al., 2025http://creativecommons.org/licenses/by-nc/3.0/es/Malalties autoimmunitàriesImmunoglobulina GImmunoglobulinesMalalties del sistema nerviósAutoimmune diseasesImmunoglobulin GImmunoglobulinsNervous system Diseasesinfo:eu-repo/semantics/article2025-06-19info:eu-repo/semantics/openAccess40247653