The Results of ADVANCE-CIDP IVIG Trial: Intravenous Immunoglobulin 10% Therapy With GAMMAGARD LIQUID/Kiovig for Treatment of Relapse in Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Authors: Pasnoor, M; Anderson-Smits, C; Levine, T; Bril, V; Solano, JM; Rejdak, K; Gamez, J; Chroni, E; Casasnovas, C; Marchioni, E; Siciliano, G; Cocito, D; Sivakumar, K; Rivero, A; Duff, K; Greco, E; Corbo, M; Hasan, S; Dori, A; Schmidt, J; Wood, J; Li, Z; Ay, H

Affiliations: University of Kansas Medical Center, Kansas City, Kansas, USA. Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA. CND Life Sciences, Phoenix, Arizona, USA. The Ellen and Martin Prosserman Centre for Neuromuscular Diseases, University Health Network, University of Toronto, Toronto, Ontario, Canada. IPS Universitaria and Neuromuscular Disorders Research Group, University of Antioquia, Medellín, Colombia. Department of Neurology, Medical University of Lublin, Lublin, Poland. Department of Neurology, GMA Clinic, Barcelona, Spain. Autonomous University of Barcelona, Barcelona, Spain. Department of Neurology, Medical School, University of Patras, Rion, Achaia, Greece. Bellvitge University Hospital, Barcelona, Spain. IRCCS Fondazione Mondino, Pavia, Italy. University Hospital of Pisa, Pisa, Italy. University of Turin, Turin, Italy. Neuromuscular Clinic and Research Center of Arizona, Phoenix, Arizona, USA. Institute for Neurological Research (FLENI), Buenos Aires, Argentina. Department of Neurorehabilitation Sciences, Casa di Cura Igea, Milan, Italy. Department of Neurology, Chaim Sheba Medical Center, Ramat Gan, Israel. Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel. Department of Neurology, Neuromuscular Center, University Medical Center Göttingen, Göttingen, Germany. Department of Neurology and Pain Treatment, Neuromuscular Center, Center for Translational Medicine, Immanuel Klinik Rüdersdorf, University Hospital of the Brandenburg Medical School Theodor Fontane, Rüdersdorf bei Berlin, Germany.

Publication: European journal of neurology; 2025; 32. e70110

ABSTRACT: 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 relapses and improved functional abilities.