https://repositorio.fleni.org.ar/xmlui/handle/123456789/18 2026-04-05T19:29:43Z 2026-04-05T19:29:43Z Pasnoor, Mamatha Anderson-Smits, Colin Levine, Todd Bril, Vera Solano, Juan Marcos Rejdak, Konrad Gamez, Josep Chroni, Elisabeth Casasnovas, Carlos Marchioni, Enrico Siciliano, Gabriele Cocito, Dario Sivakumar, K. Rivero, Alberto Daniel Duff, Kim Greco, Erin Corbo, Massimo Hasan, Shabbir Dori, Amir Schmidt, Jens Wood, Jamie Li, Zhaoyang Ay, Hakan https://repositorio.fleni.org.ar/xmlui/handle/123456789/1387 2025-06-17T15:29:15Z 2025-04-01T00:00:00Z

The Results of ADVANCE-CIDP IVIG Trial: Intravenous Immunoglobulin 10% Therapy With GAMMAGARD LIQUID/Kiovig for Treatment of Relapse in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Pasnoor, Mamatha; Anderson-Smits, Colin; Levine, Todd; Bril, Vera; Solano, Juan Marcos; Rejdak, Konrad; Gamez, Josep; Chroni, Elisabeth; Casasnovas, Carlos; Marchioni, Enrico; Siciliano, Gabriele; Cocito, Dario; Sivakumar, K.; Rivero, Alberto Daniel; Duff, Kim; Greco, Erin; Corbo, Massimo; Hasan, Shabbir; Dori, Amir; Schmidt, Jens; Wood, Jamie; Li, Zhaoyang; Ay, Hakan 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. Methods: Open-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. Results: Overall, 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. Conclusions: IVIG 10% effectively treated CIDP relapse and improved functional abilities.

2025-04-01T00:00:00Z Bril, Vera Hadden, Robert D.M. Brannagan, Thomas H. Bar, Michal Chroni, Elisabeth Rejdak, Konrad Rivero, Alberto Daniel Andersen, Henning Latov, Norman Levine, Todd Pasnoor, Mamatha Sacconi, Sabrina Souayah, Nizar Anderson-Smits, Colin Duff, Kim Greco, Erin Hasan, Shabbir Li, Zhaoyang Yel, Leman Ay, Hakan https://repositorio.fleni.org.ar/xmlui/handle/123456789/921 2024-01-16T13:00:01Z 2023-07-06T00:00:00Z

Hyaluronidase-facilitated subcutaneous immunoglobulin 10% as maintenance therapy for chronic inflammatory demyelinating polyradiculoneuropathy: The ADVANCE-CIDP 1 randomized controlled trial Bril, Vera; Hadden, Robert D.M.; Brannagan, Thomas H.; Bar, Michal; Chroni, Elisabeth; Rejdak, Konrad; Rivero, Alberto Daniel; Andersen, Henning; Latov, Norman; Levine, Todd; Pasnoor, Mamatha; Sacconi, Sabrina; Souayah, Nizar; Anderson-Smits, Colin; Duff, Kim; Greco, Erin; Hasan, Shabbir; Li, Zhaoyang; Yel, Leman; Ay, Hakan 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.

2023-07-06T00:00:00Z