Abstract Details

Title Efficacy of Subcutaneous Interferon ß -1a in Patients with a First Clinical Demyelinating Event in Reflex is Maintained After Application of the 2017 McDonald Criteria

Topic Multiple Sclerosis

Presentation(s) P12 - Poster Session 12 (12:00 PM-1:00 PM)

Poster/Presentation
Number 9-020

Objective

Assess the effects of subcutaneous interferon β-1a (scIFNβ-1a) on time to McDonald (2005 criteria) multiple sclerosis (MS), clinically definite (CD) MS, and annualized relapse rate (ARR) during REFLEX, stratified by retrospective diagnosis of patients at baseline that did/did not meet McDonald-2017 MS criteria.

Background scIFNβ-1a is a first-line disease modifying therapy with cumulative exposure of 1,693,031 patient-years. In REFLEX, scIFNβ-1a reduced conversion to McDonald (2005 criteria) MS and CDMS versus placebo in patients with a first clinical demyelinating event. Retrospective analysis demonstrated that overall results were unchanged after application of McDonald-2010 MS criteria. Revised McDonald-2017 MS criteria included presence of cerebrospinal fluid specific oligoclonal bands, symptomatic lesions, and cortical lesions.

Design/Methods During REFLEX, patients were randomized to scIFNβ-1a three times (tiw) or once weekly (qw), or placebo for 2-years. Patients in the intention-to-treat population were retrospectively stratified into McDonald-2017-positive (retrospectively met the McDonald-2010 MS criteria at baseline or had positive oligoclonal bands) and -negative subgroups. Kaplan-Meier curves estimated time to McDonald-2005 MS or CDMS by treatment group for each McDonald-2017 subgroup.

Results Oligoclonal band detection was optional during REFLEX and only a small number of patients were added from the McDonald-2010 analysis. Overall, 235/517 patients were McDonald-2017-positive at baseline (40 were McDonald-2010-negative but had positive oligoclonal bands). In the McDonald 2017-positive subgroup, scIFNβ-1a tiw or qw versus placebo significantly delayed time to McDonald-2005 MS (hazard ratio [HR] versus placebo: tiw, 0.47; p<0.001; qw, 0.58; p=0.002) and CDMS (HR versus placebo: tiw: 0.46; p=0.010; qw: 0.42; p=0.003). scIFNβ-1a qw and tiw significantly reduced mean ARR versus placebo in McDonald-2017-positive patients (69.1% and 59.3%; p<0.001).

Conclusions Effect of scIFNβ-1a observed in McDonald-2010 patients on time to McDonald-2005 MS and CDMS was maintained in McDonald-2017-positive patients, although there were only a small number of additional patients when the 2017 criteria were applied.

Authors/Disclosures
Mark S. Freedman, MD, F�鶹��ýӳ�� (University of Ottawa) PRESENTER	Dr. Freedman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Actelion(Janssen/J&J). Dr. Freedman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BiogenIdec. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS/Celgene. Dr. Freedman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Inc. Dr. Freedman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi-Genzyme. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Freedman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Actelion (Janssen/J&J). Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Atara Biotherapeutics. Dr. Freedman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Bayer Healthcare. Dr. Freedman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for BiogenIdec. Dr. Freedman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Clene Nanomedicine. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GRI Bio. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Magenta Therapeutics. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck Serono. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Freedman has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi Genzyme. Dr. Freedman has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi Genzyme. Dr. Freedman has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. The institution of Dr. Freedman has received research support from Sanofi Genzyme.
Ludwig Kappos, MD, F�鶹��ýӳ�� (RC2NB, University Hospital Basel)	Dr. Kappos has nothing to disclose.
	No disclosure on file
Nicola De Stefano, MD (University of Siena)	Dr. De Stefano has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck Healthcare KGaA. Dr. De Stefano has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Immunic AG. Dr. De Stefano has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis Pharma AG. Dr. De Stefano has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck Serono S.p.A. Dr. De Stefano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi Genzyme. Dr. De Stefano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche S.p.A.. The institution of Dr. De Stefano has received research support from Italian MS Society. The institution of Dr. De Stefano has received research support from Merck Healthcare KGaA.
Sanjeev Roy	Sanjeev Roy has received personal compensation for serving as an employee of Merck KgGA.
Delphine Issard, MD (Merck-Serono S.A)	Dr. Issard has nothing to disclose.

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