Highlights
- •MRI activity at 6 months in CIS was evaluated as an indicator of later clinical activity.
- •At 6 months, 29.7% of IM IFNβ-1a-treated patients had high MRI activity.
- •≥2 new T2 and/or Gd+ lesions predicted higher relapse risk in IM IFNβ-1a-treated patients.
- •Interaction in behavior of treated vs placebo indicates this may be a guide in management.
Abstract
Objective
Determine whether MRI activity 6 months after treatment initiation in the Controlled
High-Risk Subjects Avonex® Multiple Sclerosis Prevention Study (CHAMPS) predicted progression to clinically
definite multiple sclerosis (CDMS) over the subsequent 30 months in intramuscular
interferon beta-1a (IM IFNβ-1a)-treated patients vs placebo-treated patients.
Methods
CHAMPS patients were randomized to once-weekly IM IFNβ-1a 30 μg or placebo for up to 36 months. MRI was performed every 6 months until CDMS confirmation.
Patient groups were defined based on new T2 and/or Gd+ lesions at 6 months.
Results
Thirteen IM IFNβ-1a patients (6.7%) and 24 placebo patients (12.6%) developed CDMS
prior to month 6 and did not undergo the 6-month MRI. At 6 months, 29.7% of IM IFNβ-1a-treated
patients vs 40.9% of placebo-treated patients were defined as having high MRI activity
levels (≥2 new T2 and/or ≥2 Gd+ lesions). In this subgroup, estimated cumulative probabilities
of CDMS were similar between groups (HR=0.88 [0.44–1.77], p=0.7227). A significant treatment response was seen for patients with <2 new T2 and
<2 Gd+ lesions at 6 months (HR=0.39 [0.19–0.82], p=0.0120).
Conclusion
MRI scans 6 months after IM IFNβ-1a initiation in CIS patients predict early treatment
non-response. Standardized scanning and monitoring may facilitate early disease management.
Abbreviations:
CDMS (clinically definite multiple sclerosis), CHAMPS (Controlled High-Risk Subjects Avonex Multiple Sclerosis Prevention Study), CHAMPIONS (Controlled High-Risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurologic Surveillance), CI (confidence interval), CIS (clinically isolated syndrome), CIS+MRI (clinically isolated syndrome who exhibit characteristic lesions on magnetic resonance imaging), CNS (central nervous system), Gd+ (gadolinium-enhancing), HR (hazard ratio), IFNβ (interferon beta), IM (intramuscular), MRI (magnetic resonance imaging), MS (multiple sclerosis), RRMS (relapsing–remitting multiple sclerosis), SD (standard deviation)Keywords
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Article info
Publication history
Published online: August 26, 2014
Accepted:
August 18,
2014
Received in revised form:
July 31,
2014
Received:
May 23,
2014
Identification
Copyright
© 2014 Elsevier B.V. Published by Elsevier Inc. All rights reserved.
