Presentation of 2 posters on the LFB PRISM study results at ICNMD 2021 Virtual Congress

LFB will present 2 posters on the results of PRISM Study [1] during the 16th International Congress on Neuromuscular Diseases (ICNMD) 2021. The congress is held virtually on 21,22 and 28,29 May 2021.

Efficacy and safety of the LFB IGIV 10% in patients with CIDP: PRISM-study results

  1. Ouaja1, R. Bonek2, D. Cocito3, A. Schenone4, S. Pujol1, and E. Nobile-Orazio5 on behalf on the PRISM study investigators

When should we consider that CIDP patient is non-responder to IVIg?

  1. Ouaja1, R. Bonek2, D. Cocito3, A. Schenone4, S. Pujol1, F. Kasiborski1 and E. Nobile-Orazio5 on behalf on the PRISM study investigators

 

About PRISM

 

The PRISM study (NCT02293460) is an international, single arm, open-label, multicenter, Phase 3 clinical trial designed to evaluate the efficacy and safety of LFB IVIg 10% in the initial and maintenance treatment of CIDP patients.

Based on the doses recommended in the EFNS/PNS guideline [2], LFB IVIg 10% was administered at 2 g/kg over 2 to 5 days for the first course, then at 1 g/kg over 1 to 2 days every 3 weeks for the rest of the study. The primary efficacy endpoint was Responder rate at End of Study (EOS) visit [Response was defined as an improvement of ≥1 point on the Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale between baseline and EOS]. The responder rate was compared with the responder rate of a historical placebo group (33.3%) from the ICE study [3].

Results from this clinical trial confirmed the efficacy and safety of LFB IVIg 10% in the treatment of CIDP patients (N=43). The overall response rate at EOS was 76.2% (95% CI [60.5-87.9%]). The superiority of LFB IVIg 10% compared to the historical placebo control was demonstrated (p<0.0001). Results of one of the secondary endpoints of this study may suggest that CIDP patients (Ig-pretreated or naïve) should be maintained on IVIg treatment for a longer time (6 months) before considering other alternative therapy. The median time to response was 15 weeks (95% CI [8.9 – 19.1]) and 29% of the patients were responsive at a later time point (after Week 12 and until EOS visit). The safety was in line with the use of IVIg in CIDP.

This Phase 3 trial study is sponsored by LFB.

More details can be found in the study manuscript available at https://onlinelibrary.wiley.com/doi/full/10.1111/jns.12408

 

 

About CIDP

 

CIDP is a rare neurological disorder in which there is inflammation of nerve roots and peripheral nerves and destruction of the fatty protective covering (myelin sheath) over the nerves. This affects how fast the nerve signals are transmitted and leads to loss of nerve fibers. This causes weakness, paralysis and/or impairment in motor function, especially of the arms and legs.

 

References:

 

[1] Nobile-Orazio E et al. An international multicenter efficacy and safety study of IQYMUNE® in initial and maintenance treatment of patients with chronic inflammatory demyelinating polyradiculoneuropathy: PRISM study. J Peripher Nerv Syst 2020 Aug. doi: 10.1111/jns.12408. Online ahead of print.

 

[2] European Federation of Neurological Societies/Peripheral Nerve Society Guideline on management of chronic inflammatory demyelinating polyradiculoneuropathy: report of a joint task force of the European Federation of Neurological Societies and the Peripheral Nerve Society–First Revision. Joint Task Force of the EFNS and the PNS. J Peripher Nerv Syst 2010 Mar;15 (1).

 

[3] Hughes RAC, Donofrio P, Bril V, et al. Intravenous immune globulin (10% caprylate chromatography purified) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE study): a randomised placebo-controlled trial. Lancet Neurol 2008;7:136–144.