DX30
Correlation of Clinical, MRI, and OCT Outcomes in the 11-Year Follow up from Benefit: Benefit 11

Thursday, June 2, 2016
Exhibit Hall
Edward J Fox, MD , Central Texas Neurology Consultants, Round Rock, TX
Gilles Edan, MD , CHU Hopital Pontchaillou, Rennes, France
Mark S Freedman, MD , University of Ottawa and Ottawa Hospital Research Institute, Ottawa, ON, Canada
Xavier Montalban, MD, PhD , Hospital Universitari Vall d’Hebron, Barcelona, Spain
Hans-Peter Hartung, MD, FRCP, FAAN, FANA , Department of Neurology, Heinrich-Heine Universität, Düsseldorf, Germany
Bernhard Hemmer, MD , Munich Cluster for Systems Neurology (SyNergy), Munich, Germany
Frederik Barkhof, MD, PhD , VU University Medical Center, Amsterdam, Netherlands
Sven Schippling, MD , University Hospital Zurich, Zurich, Switzerland
Frederick W Foley, Ph.D. , School of Psychology, Yeshiva University, New York, NY
Iris-Katharina Penner, PD , COGITO Center for Applied Neurocognition and Neuropsychological Research, Düsseldorf, Germany
Ralf Koelbach, MSc , PAREXEL International, Berlin, Germany
Dirk Pleimes, MD , Myelo Therapeutics GmbH, Berlin, Germany
Gustavo Suarez, MD , Bayer HealthCare Pharmaceuticals, Whippany, NJ
Eva-Maria Wicklein, MD , Bayer Pharma AG, Berlin, Germany
Ludwig Kappos, MD, PhD , Neurology, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, Basel, Switzerland
Beth Gates, BA , Precept Medical Communications, Warren, NJ
Robert Ristuccia, PhD , Precept Medical Communications, Warren, NJ
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Background:

Patients with clinically isolated syndrome (CIS) who had early treatment with interferon beta-1b in the BENEFIT trial had significantly better clinical outcomes up to 11 years after randomization when compared with patients who had delayed treatment and had more favorable MRI outcomes up to the 5-year analysis.

Objectives:

To report correlations between clinical, MRI, and optical coherence tomography (OCT) outcomes over 11 years

Methods:

Patients with CIS who had ≥2 clinically silent brain lesions on MRI were randomized to interferon beta-1b (early treatment) or placebo (delayed treatment). Patients remained on placebo until conversion to clinically definite MS or for 2 years. All patients were approached to undergo cross-sectional follow-up that included clinical assessment plus MRI and OCT at 11 years. Correlations were assessed with Spearman’s rank coefficients.

Results:

Of the 468 patients originally randomized, 278 (59.4%) participated in BENEFIT 11 (early treatment: 167 patients (63.1%), delayed treatment: 111 patients (57.2%). Year 11 MRI and OCT data were available from 191 (68.7%) and 86 (30.9%) patients, respectively. ARR correlated positively with T1 hypointensity volume (r=0.212, P=.0069) and T2 volume (r=0.216. P=.0058) and negatively with mean upper spinal cord area (MUCCA, r=-0.208, P=.0083), minimum global-retinal nerve fiber layer (G-RNFL) thickness (r=-0.233, P=.0396) and minimum papillomacular bundle-retinal nerve fiber layer (PMB-RNFL) thickness (r=-0.239, P=.0347). EDSS score correlated positively with T1 hypointensity volume (r=0.281, P=.0003) and T2 volume (r=0.244, P=.0018), and negatively with MUCCA (r=-0.194, P=.0137). MSFC correlated negatively with T1 and T2 lesion volume (r=-0.183, P=.0267 and r=-0.213, P=.0094). PASAT correlated positively with minimum G-RNFL thickness (r=0.271, P=.0197). T1 and T2 lesion volume correlated negatively with minimum G-RNFL (r=-0.255, P=.0422 and r=-0.307, P=.0136) and PMB-RNFL (r=-0.340, P=.0059 and r=-0.392, P=.0014). Mental processing speed (sum of the z-scores for PASAT and SDMT adjusted for education status, age, and sex) correlated negatively with number of T1 lesions (r=-0.176, P=.0355).

Conclusions:

BENEFIT 11 confirmed the relationship between MRI metrics and long-term clinical outcomes. Results also indicated that patients with more active disease tended to have smaller cervical spinal cord volumes. Cognition (as measured by mental processing speed) was related to lesion number.

See more of: Disease Modification
See more of: CMSC
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