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Treatment With Erythropoietin for Patients With Optic Neuritis: Long-term Follow-up
Sebastian Küchlin1, Gabriele Ihorst1, Birgit Grotejohann1
1From the Eye Center (S.K., S.P.H., W.A.L.); Clinical Trials Unit (G.I., B.G.), Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg; Department of Ophthalmology (F.B.), University Hospital, University of Heidelberg; Department of Neurology (P.A.), Medical Faculty, Heinrich Heine-Universität Düsseldorf; Aalen University of Applied Sciences (J.U., M.W.), Competence Center Vision Research; Pharmacy (M.J.H.), Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany; Department of Ophthalmology (S.W.), Inselspital, University Hospital, University of Bern, Switzerland; and Department of Neurology and National Center for Tumor Diseases (R.D.), Faculty of Medicine, University Hospital Heidelberg, Germany.
Background And Objective:
Erythropoietin (EPO) is a candidate neuroprotective drug. We assessed its long-term safety and efficacy as an adjunct to methylprednisolone in patients with optic neuritis and focused on conversions to multiple sclerosis (MS).
Methods:
The TONE trial randomized 108 patients with acute optic neuritis but without previously known MS to either 33,000 IU EPO or placebo in conjunction with 1,000 mg methylprednisolone daily for 3 days. After reaching the primary end point at 6 months, we conducted an open-label follow-up 2 years after randomization.
Results:
The follow-up was attended by 83 of 103 initially analyzed patients (81%). There were no previously unreported adverse events. The adjusted treatment difference of peripapillary retinal nerve fiber layer atrophy in relation to the fellow eye at baseline was 1.27 µm (95% CI -6.45 to 8.98, p = 0.74). The adjusted treatment difference in low-contrast letter acuity was 2.87 on the 2.5% Sloan chart score (95% CI -7.92 to 13.65). Vision-related quality of life was similar in both treatment arms (National Eye Institute Visual Functioning Questionnaire median score [IQR]: 94.0 [88.0 to 96.9] in the EPO and 93.4 [89.5 to 97.4] in the placebo group). The rate of multiple sclerosis-free survival was 38% in the placebo and 53% in the EPO group (hazard ratio: 1.67, 95% CI 0.96 to 2.88, p = 0.068).
Discussion:
In line with the results at 6 months, we found neither structural nor functional benefits in the visual system of patients with optic neuritis as a clinically isolated syndrome, 2 years after EPO administration. Although there were fewer early conversions to MS in the EPO group, the difference across the 2-year window was not statistically significant.
Classification Of Evidence:
This study provides Class II evidence that for patients with acute optic neuritis, EPO as an adjunct to methylprednisolone is well tolerated and does not improve long-term visual outcomes.
Trial Registration Information:
The trial was preregistered before commencement at clinicaltrials.gov (NCT01962571).
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