An international multicenter efficacy and safety study of IQYMUNE in initial and maintenance treatment of patients with chronic inflammatory demyelinating polyradiculoneuropathy: PRISM study

Eduardo Nobile-Orazio, Sonia Pujol, Fabrice Kasiborski, Rabye Ouaja, Gilles Della Corte, Robert Bonek, Dario Cocito, Angelo Schenone

Research output: Contribution to journalArticlepeer-review

Abstract

This prospective, multicenter, single-arm, open-label phase 3 study aimed to evaluate the efficacy and safety of IqYmune in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). Patients received one induction dose of 2 g/kg and then seven maintenance doses of 1 g/kg at 3-week intervals. The primary endpoint was the responder rate at the end of study (EOS), defined as an improvement of ≥1 point on the adjusted inflammatory neuropathy cause and treatment (INCAT) disability scale. The responder rate was compared with the responder rate of a historical placebo group (33.3%). Secondary endpoints included changes from baseline to EOS of adjusted INCAT disability score, grip strength, Medical Research Council (MRC) sum score, Rasch-modified MRC sum score, Rasch-built overall disability scale score and the clinical global impression. Forty-two patients, including 23 Ig-naïve and 19 Ig-pre-treated, were included in the efficacy set. The overall response rate at EOS was 76.2% (95% confidence interval [60.5%-87.9%]). The superiority of IqYmune compared to the historical placebo control was demonstrated (P
Original languageEnglish
JournalJournal of the Peripheral Nervous System
DOIs
Publication statusPublished - 2020

Keywords

  • chronic inflammatory demyelinating polyradiculoneuropathy
  • inflammatory neuropathy cause and treatment
  • intravenous immunoglobulin
  • IqYmune
  • PRISM

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