Abstract Details

Title The Impact of Natalizumab Treatment on Optical Coherence Tomography (OCT) and Visual Acuity (VA) in Anti–JC Virus (JCV) Antibody Negative Patients with Early Relapsing-Remitting Multiple Sclerosis (RRMS)

Topic Multiple Sclerosis

Presentation(s) MS and CNS Inflammatory Disease Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 247

Objective To assess changes in retinal nerve fiber layer (RNFL) thickness and high-contrast (100%) and low-contrast (2.5% or 1.25%) VA in an early RRMS population treated with natalizumab.

Background OCT, a noninvasive imaging technique to quantitatively measure RNFL thickness, and low-contrast letter acuity are potential surrogate measures of multiple sclerosis disease activity.

Design/Methods STRIVE was a phase 4 study of natalizumab-treated anti–JCV antibody negative patients with early RRMS. OCT and VA testing were conducted at baseline, month 24 and month 48 in a patient subgroup. Visual improvement and loss were defined as a ≥5-letter (100% contrast) or ≥7-letter (2.5% and 1.25% contrast) increase or decrease, respectively, at follow-up. Results are shown for patients with data at all time points.

Results At baseline, patients (n=39) had a mean (standard deviation [SD]) RNFL thickness of 96.67 (15.10) μm and 82.0% of patients had a visual functional system score of 0 or 1, indicating generally healthy visual function with limited vision loss. At month 24 and 48, the mean overall change from baseline in RNFL thickness was −1.81 μm (95% confidence interval [CI]: −3.00 μm, −0.61 μm [n=39], P=0.0030) and −2.89 μm (95% CI: −4.53 μm, −1.25 μm [n=39], P=0.0006), respectively. At month 48, a greater percentage of patients exhibited visual improvement than loss when examined at high contrast (25.0% vs 13.9%) or low contrast (38.5% vs 20.5% for 2.50% contrast; 48.7% vs 38.5% for 1.25% contrast).

Conclusions These results, although limited by the small sample size, demonstrate relatively small reductions in RNFL thickness and a higher proportion of patients with improvement than worsening in VA. RNFL thinning in STRIVE was greater than healthy RNFL thinning (~0.5 μm per year), but was less than that reported in an MS comparator cohort, 87% of whom were on disease-modifying therapy (Talman et al., 2010).

Authors/Disclosures
Laura J. Balcer, MD, MSCE, FAAN (NYU Grossman School of Medicine) PRESENTER	An immediate family member of Dr. Balcer has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Children's Hospital of Philadelphia.
	No disclosure on file
Roumen D. Balabanov, MD (Northwestern University)	Dr. Balabanov has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Balabanov 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. Balabanov has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Balabanov has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. The institution of Dr. Balabanov has received research support from NextCure. The institution of Dr. Balabanov has received research support from Biogen. The institution of Dr. Balabanov has received research support from NINDS.
Robert J. Fox, MD, FAAN (Cleveland Clinic)	Dr. Fox has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AB Science. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BMS. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Serono. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Immunic. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Siemens. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astoria Biologica. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving as a Consultant for InnoCare Pharma. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunic. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AB Science. Dr. Fox 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. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS. The institution of Dr. Fox has received research support from National Institutes of Health. The institution of Dr. Fox has received research support from National MS Society. Dr. Fox has received publishing royalties from a publication relating to health care.
	No disclosure on file
Denise I. Campagnolo, MD, MS	Dr. Campagnolo has received personal compensation for serving as an employee of Biogen. Dr. Campagnolo has received stock or an ownership interest from Biogen.
Robin L. Avila, PhD (Biogen)	Mrs. Avila has received personal compensation for serving as an employee of Biogen. Mrs. Avila has stock in Biogen.
Danette J. Rutledge, PhD	Ms. Rutledge has received personal compensation for serving as an employee of Biogen. Ms. Rutledge has stock in Biogen.
Steven Galetta, MD, FAAN (NYU Langone Medical Center)	Dr. Galetta has nothing to disclose.

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