Effects of Anti-LINGO-1 Monoclonal Antibody BIIB033 on Vision-Related Quality-of-Life in Subjects with Acute Optic Neuritis: Results from the RENEW Study (P7.213)

OBJECTIVE: To compare patient-reported vision-related quality of life (VRQoL) of participants with acute optic neuritis (AON) randomized to treatment with the anti-LINGO-1 monoclonal antibody BIIB033 or placebo in the RENEW study. BACKGROUND: AON is frequently the first manifestation of multiple sclerosis (MS). The resultant structural and functional optic nerve changes can impair vision permanently. Whilst treatment with high dose methyl prednisolone may improve the speed of recovery, no existing treatments enhance recovery. Anti-LINGO-1 (BIIB033) is being investigated as a potential remyelinating and neuroaxonal protective agent in people with CNS demyelinating diseases. It is a monoclonal antibody targeted against LINGO-1, a CNS membrane glycoprotein that suppresses oligodendrocyte differentiation and myelination. DESIGN/METHODS: RENEW is a phase 2, randomized, placebo-controlled, trial of BIIB033 efficacy, safety and tolerability for treating people with their first episode of unilateral AON. Participants were randomized to monthly IV BIIB033 (100 mg/kg) or placebo for 5 months (6 doses). VRQoL was measured using the 25-item National Eye Institute Visual Functioning Questionnaire plus the 13 optional items and the 10-item Neuro-Ophthalmic Supplement administered at baseline and monthly for eight months. RESULTS: 82 subjects were randomized to BIIB033 or placebo. The results for the traditional scoring of the NEI-VFQ-25 with the 13 optional items and the 10-item Neuro-Ophthalmologic Supplement will be reported separately and together. Novel exploratory Rasch measurement theory-based analyses of optimal scoring with items relevant to AON will also be presented. CONCLUSIONS: RENEW will provide valuable data regarding the potential benefits of BIIB033 for VRQoL in AON. Study Supported by: Biogen Idec. Disclosure: Dr. Petrillo has received personal compensation for activities with Biogen Idec as an employee. Dr. Hobart has received personal compensation for activities with Biogen Idec, Acorda Therapeutics, Novartis, and Merck Serono. Consultant/advisor for Biogen Idec, Genzyme, Vaccinex, Dr. Chai has received personal compensation for activities with Biogen Idec as en employee. Dr. Xu has received personal compensation for activities with Biogen Idec as an employee. Dr. Cadavid has received personal compensation for activities with Biogen Idec as an employee.