An international multicenter efficacy and safety study of IqYmune in initial and maintenance treatment of patients with chronic inflammatory demyelinating polyradiculoneuropathy: PRISM study.
IqYmune
PRISM
chronic inflammatory demyelinating polyradiculoneuropathy
inflammatory neuropathy cause and treatment
intravenous immunoglobulin
Journal
Journal of the peripheral nervous system : JPNS
ISSN: 1529-8027
Titre abrégé: J Peripher Nerv Syst
Pays: United States
ID NLM: 9704532
Informations de publication
Date de publication:
12 2020
12 2020
Historique:
received:
28
05
2020
revised:
07
08
2020
accepted:
10
08
2020
pubmed:
19
8
2020
medline:
28
9
2021
entrez:
19
8
2020
Statut:
ppublish
Résumé
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 < .0001). The responder rate was numerically higher in Ig-pre-treated than in Ig-naïve patients but confidence intervals were overlapping (84.2% [60.4%-96.6%] vs 69.6% [47.1%-86.8%]). All secondary endpoints confirmed this conclusion. The median time to response was 15 weeks [8.9-19.1 weeks]. A total of 156 adverse events including five serious were considered related to IqYmune, 87.2% were mild. Neither hemolysis nor signs of renal or hepatic impairment were observed. These results demonstrate that IqYmune is an effective and well-tolerated treatment in patients with CIDP.
Identifiants
pubmed: 32808406
doi: 10.1111/jns.12408
pmc: PMC7754365
doi:
Substances chimiques
Immunoglobulins, Intravenous
0
Immunologic Factors
0
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
356-365Informations de copyright
© 2020 The Authors. Journal of the Peripheral Nervous System published by Wiley Periodicals LLC on behalf of Peripheral Nerve Society.
Références
J Peripher Nerv Syst. 2019 Mar;24(1):56-63
pubmed: 30456899
Eur J Neurol. 2008 Sep;15(9):893-908
pubmed: 18796075
PDA J Pharm Sci Technol. 2018 Mar-Apr;72(2):176-187
pubmed: 29158287
J Neurol. 2013 Aug;260(8):2052-6
pubmed: 23645220
J Peripher Nerv Syst. 2020 Dec;25(4):356-365
pubmed: 32808406
Lancet Neurol. 2008 Feb;7(2):136-44
pubmed: 18178525
Nat Rev Neurol. 2011 Aug 16;7(9):507-17
pubmed: 21844897
J Clin Immunol. 2017 Aug;37(6):539-547
pubmed: 28711959
J Peripher Nerv Syst. 2019 Mar;24(1):48-55
pubmed: 30672091
J Peripher Nerv Syst. 2013 Jun;18(2):130-40
pubmed: 23781960
J Hematol. 2018 Sep;7(3):87-95
pubmed: 32300420
Eur J Neurol. 2010 Mar;17(3):356-63
pubmed: 20456730
Muscle Nerve. 2000 Sep;23(9):1393-401
pubmed: 10951442
J Peripher Nerv Syst. 2011 Jun;16 Suppl 1:38-40
pubmed: 21696496
Neuromuscul Disord. 2013 Nov;23(11):924-33
pubmed: 23835324
J Peripher Nerv Syst. 2018 Jun;23(2):78-87
pubmed: 29573033
J Neurol Neurosurg Psychiatry. 1999 May;66(5):677-80
pubmed: 10209187