Contributions
Abstract: EP1624
Type: Poster Sessions
Abstract Category: Therapy - Neuroprotection and Repair
Background: Retinal atrophy may be an early indicator of progression in relapsing-remitting multiple sclerosis (RRMS). It is unclear whether rates of retinal atrophy are affected differentially by disease modifying therapies (DMT). Here, we present the protocol and preliminary results for a prospective cohort study analyzing retinal nerve fiber layer (RNFL) thickness on dimethyl fumarate (DMF) therapy compared to other DMT.
Methods/Design: One hundred patients with the diagnosis of RRMS will undergo Ocular Coherence Tomography (OCT) every 6 months over 2 years. Participants will be assigned to first-line DMT, second-line DMT, and DMF groups based on the medication they have spent the greatest number of days on. The primary outcome is change in RNFL thickness. Secondary outcomes include change in macular thickness and macular volume. Tertiary outcomes include relapse, new T2/gadolinium-enhancing lesions on brain MRI, and changes in the Expanded Disability Status Scale (EDSS). Statistical analysis is performed using linear mixed effects models, with correction for inter-eye correlation. We controlled for age, ethnicity, disease duration, baseline RNFL thickness, and baseline EDSS.
Results: Data collection is underway with 100 patients recruited. In a preliminary analysis of 33 patients with at least one year of follow-up, the three treatment groups were balanced for most baseline parameters, except for decreased baseline RNFL and macular volume in patients on DMF. There is a trend towards increased RNFL thinning in subjects on DMF and second-line DMT compared to first-line DMT (p=0.18 and p=0.092, respectively). Non-Caucasian ethnicity is a significant predictor of RNFL thinning.
Conclusion: No statistically significant difference in RNFL thinning was observed across treatment groups in this preliminary analysis. Analysis will be repeated when all 100 patients have at least one year of follow-up. Using OCT measurements as early surrogate markers for MS progression, results from this study will aid in selection of treatment for MS patients.
Disclosure: Anna Kabanovski: nothing to disclose
Kirill Zaslavsky: nothing to disclose
Dalia Rotstein: received speaker´s honoraria or consulting fees from EMD Serono, Biogen, Novartis, Sanofi, and Roche
Edward Margolin: received grant funding from Biogen to conduct this study
Abstract: EP1624
Type: Poster Sessions
Abstract Category: Therapy - Neuroprotection and Repair
Background: Retinal atrophy may be an early indicator of progression in relapsing-remitting multiple sclerosis (RRMS). It is unclear whether rates of retinal atrophy are affected differentially by disease modifying therapies (DMT). Here, we present the protocol and preliminary results for a prospective cohort study analyzing retinal nerve fiber layer (RNFL) thickness on dimethyl fumarate (DMF) therapy compared to other DMT.
Methods/Design: One hundred patients with the diagnosis of RRMS will undergo Ocular Coherence Tomography (OCT) every 6 months over 2 years. Participants will be assigned to first-line DMT, second-line DMT, and DMF groups based on the medication they have spent the greatest number of days on. The primary outcome is change in RNFL thickness. Secondary outcomes include change in macular thickness and macular volume. Tertiary outcomes include relapse, new T2/gadolinium-enhancing lesions on brain MRI, and changes in the Expanded Disability Status Scale (EDSS). Statistical analysis is performed using linear mixed effects models, with correction for inter-eye correlation. We controlled for age, ethnicity, disease duration, baseline RNFL thickness, and baseline EDSS.
Results: Data collection is underway with 100 patients recruited. In a preliminary analysis of 33 patients with at least one year of follow-up, the three treatment groups were balanced for most baseline parameters, except for decreased baseline RNFL and macular volume in patients on DMF. There is a trend towards increased RNFL thinning in subjects on DMF and second-line DMT compared to first-line DMT (p=0.18 and p=0.092, respectively). Non-Caucasian ethnicity is a significant predictor of RNFL thinning.
Conclusion: No statistically significant difference in RNFL thinning was observed across treatment groups in this preliminary analysis. Analysis will be repeated when all 100 patients have at least one year of follow-up. Using OCT measurements as early surrogate markers for MS progression, results from this study will aid in selection of treatment for MS patients.
Disclosure: Anna Kabanovski: nothing to disclose
Kirill Zaslavsky: nothing to disclose
Dalia Rotstein: received speaker´s honoraria or consulting fees from EMD Serono, Biogen, Novartis, Sanofi, and Roche
Edward Margolin: received grant funding from Biogen to conduct this study