Contributions
Abstract: P660
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Acute Optic neuritis (AON) is a common presentation in Multiple Sclerosis. Based on the landmark optic neuritis treatment trial (ONTT), intravenous (IV) corticosteroids is thought to be superior to oral administration for the treatment of AON. However, the ONTT did not compare bioequivalent oral and IV doses, using a significantly lower corticosteroid dose in the oral group. Thus, it is not known if IV treatment is truly superior to oral treatment for AON.
Objectives: To determine if treatment for AON with high dose corticosteroids administered IV is superior to a bioequivalent dose of oral corticosteroids.
Methods: We recruited consecutive subjects, with or without known MS, presenting with AON requiring corticosteroids, without a history of AON in the same eye. Visual acuity (VA) had to be 20/40 or worse, a relative afferent pupillary defect had to be present, symptoms were not improving and were present for less than 14 days. Subjects were randomized to 1000mg IV methylprednisolone daily or 1250mg oral prednisone daily for three days; subjects were not blinded but all assessors were blinded to treatment assignment. The primary outcome was recovery of the P100 visual evoked potential (VEP) latency signal at 6 months; secondary outcomes included P100 VEP signal at 1 month and VA at 1 and 6 months.
Results: Fifty one subjects were initially recruited; 4 subjects (3 oral, 1 IV) were removed due to an alternative diagnosis to AON and 1 subject randomized to IV required re-treatment 4 weeks after recruitment, leaving 23 subjects in each of the oral and IV groups. 39 subjects completed all 3 assessments. The left eye was affected in 27/46 (58.7%); this was the 1st demyelinating event in 24 (52.2%). The median VA at time of presentation was 20/150 (range 20/40 to no light perception) and mean P100 was 192.3ms (SD 60.6). At baseline, VEP in the oral group was 202.7ms (SD 66.4) and 181.9ms (SD 53.6) in the IV group (p=0.251); median VA was 20/200 in the oral group and 20/100 in the IV group (p=0.916). At 6 months, VEP had improved significantly to 133.8ms (SD 31.5) in the oral and 119.0ms (SD 16.5) in the IV group, which was not significantly different (p=0.10). Similarly VEPs at 1 month were not significantly different between groups (p=0.75), nor was VA at 1 month (p=0.236) and 6 months (p=0.219).
Conclusion: IV administration of high dose (> 1000mg) corticosteroids is not superior to bioequivalent oral treatment in AON.
Disclosure: This study was funded by a Physicians" Services Incorporated Foundation Grant.
Dr. Morrow has received honoraria for speaking, consulting, and advisory board participation from Biogen Idec, EMD Serono, Genzyme, Novartis, and Teva Neuroscience. She has acted as site principal investigator for clinical trials for Biogen Idec. She has received investigator initiated study funds from Biogen Idec, Genzyme and Novartis and funding from the National MS Society and the Multiple Sclerosis Society of Canada.
Dr. Kremenchutzky has received research grants and research support from Biogen, the Canadian Institute of Health Research [CIHR], Genzyme, the MS Society of Canada, Novartis, Sanofi, Teva, and Wellesley Therapeutics. He has received personal compensation for consulting from Biogen, Genzyme and Novartis.
Dr. Fraser, Dr. Nicolle, Ms. Bowman, Ms. Rosehart and Mr. Day have nothing to disclose.
Abstract: P660
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Acute Optic neuritis (AON) is a common presentation in Multiple Sclerosis. Based on the landmark optic neuritis treatment trial (ONTT), intravenous (IV) corticosteroids is thought to be superior to oral administration for the treatment of AON. However, the ONTT did not compare bioequivalent oral and IV doses, using a significantly lower corticosteroid dose in the oral group. Thus, it is not known if IV treatment is truly superior to oral treatment for AON.
Objectives: To determine if treatment for AON with high dose corticosteroids administered IV is superior to a bioequivalent dose of oral corticosteroids.
Methods: We recruited consecutive subjects, with or without known MS, presenting with AON requiring corticosteroids, without a history of AON in the same eye. Visual acuity (VA) had to be 20/40 or worse, a relative afferent pupillary defect had to be present, symptoms were not improving and were present for less than 14 days. Subjects were randomized to 1000mg IV methylprednisolone daily or 1250mg oral prednisone daily for three days; subjects were not blinded but all assessors were blinded to treatment assignment. The primary outcome was recovery of the P100 visual evoked potential (VEP) latency signal at 6 months; secondary outcomes included P100 VEP signal at 1 month and VA at 1 and 6 months.
Results: Fifty one subjects were initially recruited; 4 subjects (3 oral, 1 IV) were removed due to an alternative diagnosis to AON and 1 subject randomized to IV required re-treatment 4 weeks after recruitment, leaving 23 subjects in each of the oral and IV groups. 39 subjects completed all 3 assessments. The left eye was affected in 27/46 (58.7%); this was the 1st demyelinating event in 24 (52.2%). The median VA at time of presentation was 20/150 (range 20/40 to no light perception) and mean P100 was 192.3ms (SD 60.6). At baseline, VEP in the oral group was 202.7ms (SD 66.4) and 181.9ms (SD 53.6) in the IV group (p=0.251); median VA was 20/200 in the oral group and 20/100 in the IV group (p=0.916). At 6 months, VEP had improved significantly to 133.8ms (SD 31.5) in the oral and 119.0ms (SD 16.5) in the IV group, which was not significantly different (p=0.10). Similarly VEPs at 1 month were not significantly different between groups (p=0.75), nor was VA at 1 month (p=0.236) and 6 months (p=0.219).
Conclusion: IV administration of high dose (> 1000mg) corticosteroids is not superior to bioequivalent oral treatment in AON.
Disclosure: This study was funded by a Physicians" Services Incorporated Foundation Grant.
Dr. Morrow has received honoraria for speaking, consulting, and advisory board participation from Biogen Idec, EMD Serono, Genzyme, Novartis, and Teva Neuroscience. She has acted as site principal investigator for clinical trials for Biogen Idec. She has received investigator initiated study funds from Biogen Idec, Genzyme and Novartis and funding from the National MS Society and the Multiple Sclerosis Society of Canada.
Dr. Kremenchutzky has received research grants and research support from Biogen, the Canadian Institute of Health Research [CIHR], Genzyme, the MS Society of Canada, Novartis, Sanofi, Teva, and Wellesley Therapeutics. He has received personal compensation for consulting from Biogen, Genzyme and Novartis.
Dr. Fraser, Dr. Nicolle, Ms. Bowman, Ms. Rosehart and Mr. Day have nothing to disclose.