Imaging Poster Presentation

P0548 - Baseline MRI lesions as predictors of clinically definite multiple sclerosis: a post hoc analysis of RENEW and RENEWED (ID 446)

Speakers
  • L. Balcer
Authors
  • S. Galetta
  • L. Balcer
  • A. Altincatal
  • R. Su
  • O. Aktas
  • A. Klistorner
  • M. Naylor
Presentation Number
P0548
Presentation Topic
Imaging

Abstract

Background

Magnetic resonance imaging (MRI) can supplement clinical diagnostic criteria for multiple sclerosis (MS) by increasing diagnostic sensitivity and predicting the onset of clinically definite MS (CDMS).

Objectives

To determine whether the number of gadolinium-enhanced (Gd+) lesions and T2 volume at baseline (BL) may be predictors of CDMS.

Methods

RENEW (NCT01721161) was a randomised, double-blind, placebo-controlled study of participants with a first episode of acute optic neuritis who were treated with opicinumab 100 mg/kg once every 4 weeks (6 doses) and followed-up to week 32. Eligible participants were enrolled in RENEWED (NCT02657915), a 1-day follow-up (Day 1) at 2 years, to study the long-term electrophysiologic and clinical outcomes of treatment with opicinumab vs. placebo. Severity of disease using brain MRI was a secondary efficacy endpoint. In a post hoc analysis of brain MRI lesions, the number of Gd+ lesions and volume of T2 lesions at BL in RENEW were assessed for predicting CDMS at Day 1 of RENEWED for the intention-to-treat (ITT) and per protocol (PP) populations. Primary analyses were performed in the PP population.

Results

The numbers of RENEW participants who completed RENEWED were 52/82 in the ITT population (opicinumab, n=28; placebo, n=24) and 47/69 in the PP population (opicinumab, n=24; placebo, n=23). In the PP population, 40/47 (85%) did not have CDMS prior to enrollment in RENEW; 24/40 at-risk participants (opicinumab n=12; placebo n=12) developed CDMS from enrollment in RENEW up to Day 1 in RENEWED. Median time to CDMS diagnosis after enrollment in RENEW was 909.5 days in the opicinumab group and 386.0 days in the placebo group. CDMS developed in participants with Gd+ lesions and enlarged T2 volumes at RENEW baseline. The hazard ratios (95% CI; p-value) of MRI measures at BL were: presence of Gd+ lesions, 11.52 (2.20, 60.25; p<0.001); number of Gd+ lesions, 6.78 (1.97, 23.35; p=0.0024); and T2 volume, 1.80 (1.34, 2.43; p=0.0001). Participants who did not develop CDMS had no Gd+ lesions at BL and had lower T2 volumes compared with participants who developed CDMS. Results were comparable in the ITT population. No differences were found in the risk of converting to CDMS in participants treated with opicinumab vs. placebo in either the ITT or PP populations.

Conclusions

The number of Gd+ lesions and T2 volume at BL may predict the onset of CDMS. A limitation of this study is its small sample size.

Supported by: Biogen

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