TY - JOUR
T1 - A Randomized Prospective Trial Comparing Repository Corticotropin Injection and Intravenous Methylprednisolone for Neuroprotection in Acute Optic Neuritis
AU - Bennett, Jeffrey L.
AU - Grove, Nathan C.
AU - Johnson, Ruth K.
AU - Mizenko, Christopher
AU - Dupont, Joan C.
AU - Wagner, Brandie D.
AU - Lynch, Anne M.
AU - Frohman, Teresa C.
AU - Shindler, Kenneth S.
AU - Frohman, Elliot M.
N1 - Funding Information:
This trial was supported by an independent investigator grants from Mallinckrodt Pharmaceuticals (St. Louis, MO) to J. L. Bennett, E. M. Frohman and K. S. Shindler. Mallinckrodt Pharmaceuticals provided funding for the study and repository corticotropin injection (Acthar Gel). Mallinckrodt Pharmaceuticals was not involved in the design of the study, the collection of data, the analysis of data, or the drafting of the manuscript. J. L. Bennett receives additional support from National Eye Institute grants R01-EY022936, R01-, and R21-032399.
Publisher Copyright:
© 2023 by the Association of Bone and Joint Surgeons.
PY - 2023/9/1
Y1 - 2023/9/1
N2 - Background:Repository corticotrophin injection (RCI, Acthar Gel) and intravenous methylprednisolone (IVMP) improve the rate but not the extent of visual recovery following acute optic neuritis. RCI has adrenal-stimulating and melanocortin receptor-stimulating properties that may endow it with unique anti-inflammatory properties relative to IVMP.Methods:Individuals with acute optic neuritis of less than 2 weeks duration were prospectively enrolled and randomized 1:1 to receive either RCI or IVMP. Peripapillary retinal nerve fiber layer (pRNFL) and ganglion cell plus inner plexiform layer thickness (GC + IPL) were serially evaluated by OCT. In addition, patient-reported outcomes (PROs) for changes in fatigue, mood, visual function, depression, and quality of life (QOL) were measured, and high and low contrast visual acuity were recorded.Results:Thirty-seven subjects were enrolled (19 RCI; 18 IVMP); the average time from symptom to treatment was 8.8 days. At 6 months, there was no difference in the primary outcome: loss of average pRNFL thickness in the affected eye (RCI vs IVMP: -13.1 vs -11.7 µm, P = 0.88) 6 months after randomization. Additional outcomes also showed no difference between treatment groups: 6-month attenuation of GC + IPL thickness (RCI vs IVMP: -13.8 vs -12.0 µm, P = 0.58) and frequency of pRNFL swelling at 1 month (RCI vs IVMP: 63% vs 72%, P = 0.73) and 3 months (RCI vs IVMP: 26% vs 31%, P = 0.99). Both treatments resulted in improvement in visual function and PROs.Conclusions:Treatment of acute optic neuritis with RCI or IVMP produced no clinically meaningful differences in optic nerve structure or visual function.
AB - Background:Repository corticotrophin injection (RCI, Acthar Gel) and intravenous methylprednisolone (IVMP) improve the rate but not the extent of visual recovery following acute optic neuritis. RCI has adrenal-stimulating and melanocortin receptor-stimulating properties that may endow it with unique anti-inflammatory properties relative to IVMP.Methods:Individuals with acute optic neuritis of less than 2 weeks duration were prospectively enrolled and randomized 1:1 to receive either RCI or IVMP. Peripapillary retinal nerve fiber layer (pRNFL) and ganglion cell plus inner plexiform layer thickness (GC + IPL) were serially evaluated by OCT. In addition, patient-reported outcomes (PROs) for changes in fatigue, mood, visual function, depression, and quality of life (QOL) were measured, and high and low contrast visual acuity were recorded.Results:Thirty-seven subjects were enrolled (19 RCI; 18 IVMP); the average time from symptom to treatment was 8.8 days. At 6 months, there was no difference in the primary outcome: loss of average pRNFL thickness in the affected eye (RCI vs IVMP: -13.1 vs -11.7 µm, P = 0.88) 6 months after randomization. Additional outcomes also showed no difference between treatment groups: 6-month attenuation of GC + IPL thickness (RCI vs IVMP: -13.8 vs -12.0 µm, P = 0.58) and frequency of pRNFL swelling at 1 month (RCI vs IVMP: 63% vs 72%, P = 0.73) and 3 months (RCI vs IVMP: 26% vs 31%, P = 0.99). Both treatments resulted in improvement in visual function and PROs.Conclusions:Treatment of acute optic neuritis with RCI or IVMP produced no clinically meaningful differences in optic nerve structure or visual function.
UR - http://www.scopus.com/inward/record.url?scp=85168428292&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85168428292&partnerID=8YFLogxK
U2 - 10.1097/WNO.0000000000001878
DO - 10.1097/WNO.0000000000001878
M3 - Article
C2 - 37261907
AN - SCOPUS:85168428292
SN - 1070-8022
VL - 43
SP - 323
EP - 329
JO - Journal of Neuro-Ophthalmology
JF - Journal of Neuro-Ophthalmology
IS - 3
ER -