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 Raschbuilt 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.
