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Abstract Details

Effect of ibudilast on macular measures in progressive MS: OCT analysis from a phase II trial
Multiple Sclerosis
P3 - Poster Session 3 (5:30 PM-6:30 PM)
15-049
To study the effect of ibudilast on macular measures from the phase II trial of ibudilast in progressive MS.
Macular volume loss and thinning of the ganglion cell/inner plexiform layer (GCIP) are both measures of tissue injury in MS, measured by optical coherence tomography (OCT). Ibudilast 100 mg/d was found to slow the progression of brain atrophy in SPRINT-MS, a 255-patient randomized, placebo-controlled 96-week phase II trial of progressive MS. We evaluated the effect of ibudilast on macular volume loss in SPRINT-MS.
Patients underwent OCT at baseline and every 24 weeks using either Cirrus (n=185) or Spectralis (n=69) spectral domain devices. Macular volume and GCIP thickness (Cirrus only) was performed at a central reading center by independent certified graders. Imaging end points were assessed for differences in rates of change between the trial groups over time using linear mixed models. Analysis was according to modified intent-to-treat (ITT) and included all available values.
In patients followed with Spectralis OCT, the estimated rate of macular volume change was -0.005/year for ibudilast and -0.037/year for placebo (p=0.04); in patients followed with Cirrus OCT, the estimated rate of macular volume change was -0.0004/year for ibudilast and -0.0208 for placebo (p=0.1734). In patients followed with Cirrus OCT, the rate of change of GCIP was -0.489/year for ibudilast and -0.969 for placebo (p=0.12).
Annual macular volume loss using Spectralis OCT over 96 weeks was slower with ibudilast compared to placebo. Cirrus OCT demonstrated a favorable trend towards relatively reduced macular volume loss and GCIP layer thinning. These OCT results, together with the positive effect on brain atrophy and the trend for reduced disability progression, affirm a potential benefit of ibudilast in this phase II study using surrogate endpoints. The OCT analyses lend further support for a phase III trial to determine clinical benefit.
Authors/Disclosures
Robert A. Bermel, MD, FAAN (Cleveland Clinic)
PRESENTER 		Dr. Bermel has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi/Genzyme. Dr. Bermel has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech/Roche. Dr. Bermel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Bermel has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for TG Therapeutics. The institution of Dr. Bermel has received research support from Biogen. The institution of Dr. Bermel has received research support from Roche. The institution of Dr. Bermel has received research support from Novartis. Dr. Bermel has received intellectual property interests from a discovery or technology relating to health care.
Janel Fedler, PhD Dr. Fedler has nothing to disclose.
Jon Yankey (Department of Biostatistics, University of Iowa) No disclosure on file
No disclosure on file
No disclosure on file
Christopher Coffey, PhD, FAAN (University of Iowa) Dr. Coffey has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for American Heart Association. The institution of Dr. Coffey has received research support from NIH. The institution of Dr. Coffey has received research support from Michael J Fox Foundation.
Andrew D. Goodman, MD, FAAN (University of Rochester Dept. Neurology) Dr. Goodman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Swan Bio. Dr. Goodman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Goodman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Goodman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lilly. Dr. Goodman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Goodman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Goodman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for IMCYSE. Dr. Goodman has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Pfizer. The institution of Dr. Goodman has received research support from Atara. The institution of Dr. Goodman has received research support from Genzyme. The institution of Dr. Goodman has received research support from EMD-Serono.
Eric Klawiter, MD, FAAN (Massachusetts General Hospital) Dr. Klawiter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Galen/Atlantica. Dr. Klawiter 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. Klawiter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Banner Life Sciences. Dr. Klawiter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Greenwich Biosciences. Dr. Klawiter has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for OM1. Dr. Klawiter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. The institution of Dr. Klawiter has received research support from Biogen. The institution of Dr. Klawiter has received research support from Abbvie. The institution of Dr. Klawiter has received research support from Genentech.
Kazuko Matsuda, MD (Medcinova) No disclosure on file
Robert T. Naismith, MD, FAAN (Washington University) Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Naismith has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Myers Squib. Dr. Naismith has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech. Dr. Naismith has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Genzyme. Dr. Naismith has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Celltrion. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Naismith has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Serono. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astoria. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Impaact-Bio. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kyverna. Dr. Naismith has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Horizon. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for NEJM Journal Watch.
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