Abstract
Purpose :
To compare the efficacy and safety between steroid pulse therapy and combined therapy with prednisolone (PSL) and cyclosporine for acute Vogt-Koyanagi-Harada (VKH) disease.
Methods :
Methods: This was a prospective, multi-center, randomized, observer-masked study at 11 institutes in Japan. Inclusion criteria were patients ≥ 20 years with new-onset VKH disease within 2 months after the onset. The patients were randomly assigned to either (a) steroid pulse group of 1000mg or 500mg of iv methylprednisolone for 3 days followed by oral PSL (60mg or 1mg/Kg daily) with gradual tapering/off for the next 6.5 months, or (b) combined therapy group of oral PSL (60mg or 1mg/Kg daily) and cyclosporine (3mg/Kg daily starting at 35mg of PSL) and tapering/off in the next 6.5 months. Primary end points were recurrence rate for efficacy and serious adverse events (AD) to discontinue the therapy for safety. Secondary end points were best-corrected visual acuity (BCVA), subfoveal choroidal thickness, foveal retinal thickness, sunset glow fundus, and non-serious AD. Observation period was 12 months and evaluated at week 1, 2, and at month 1, 3, 6, 9, and 12. The protocol was approved by ethical committee of each institute and written informed consent was obtained from all patients.
Results :
A total of 72 patients were enrolled and 70 patients were analyzed, i.e. 36 patients for steroid pulse group and 34 for combined therapy group. There was no significant difference in backgrounds of patients between the two groups. Recurrence rate was 26.8% in steroid pulse group and 17.5% in combined therapy group (p=0.38). Three patients discontinued the treatment due to serious AD only in combined therapy group (p=0.11). There were no significant differences in BCVA, subfoveal choroidal thickness, and foveal retinal thickness. However, sunset glow fundus score was significantly higher in steroid pulse group at 6, 9, and 12 months (p=0.0007, 0.0002, and 0.0036, respectively). Cataract incidence was significantly higher in steroid pulse group at 6 months and thereafter.
Conclusions :
There was no significant difference in recurrence rate and serious AD, but sunset glow fundus score and cataract incidence was significantly higher in steroid pulse therapy than in combined therapy.
This is a 2020 ARVO Annual Meeting abstract.