Assessment timing and choice of outcome measure in determining treatment response in chronic inflammatory demyelinating polyneuropathy: A post hoc analysis of the PRISM trial.

"DISCLOSURE STATEMENT Y.A.R. has received speaker/consultancy honoraria from LFB, Polyneuron, and Argenx; has received educational support from LFB; and has received research grants from LFB and CSL Behring. R.O., F.K., and S.P. are employees of LFB. E.N.‐O. has received speaker/consultancy honoraria from Argenx, Belgium, Baxalta/Takeda (Italy and USA), CSL‐Behring (Italy and USA), Hoffmann‐La Roche (Switzerland), Janssen & Janssen (USA), Kedrion (Italy), and LFB (France). LFB had no role in determining the final content and conclusions of this article. CONFLICTS OF INTEREST None declared."

"The PRISM study was a phase III, international multicenter, single‐arm, open‐label, prospective trial of the safety and efficacy of a 10% intravenous preparation of normal human IVIg (IqYmune; LFB, Les Ulis, France) for patients with CIDP [2]. This study, approved by local independent ethics committees, was registered at ClinicalTrials.gov (NCT02293460) and EudraCT (2013–005557‐73). Details of patient selection and recruitment as well as product administration, were described in detail in earlier work. In summary, IVIg was administered at an initial dose of 2 g/kg over 2 to 5 days during the first course, then maintenance doses of 1 g/kg over 1 to 2 days repeated every 3 weeks (±7 days) during the seven subsequent courses."