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Tiffany Ching Shen Lo, Diego G Silva, Cecily Whitford, Shannon Ritter, Lyndell L Lim, Anthony John Hall; Prevalence and incidence of uveitis in a large multiple sclerosis cohort from the fingolimod clinical trials. Invest. Ophthalmol. Vis. Sci. 2017;58(8):2190.
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To investigate the prevalence and incidence of uveitis in multiple sclerosis (MS) patients in fingolimod clinical trials.Background:Uveitis is associated with MS. Several studies have reported an occurrence of uveitis in MS of between 0.4% to 26%. Fingolimod is a sphingosine-1-phosphate-receptor modulator. Its use in the treatment of MS has been extensively studied in controlled clinical trials. Patients enrolled in these clinical trials were closely followed-up for ocular side effects and underwent regular ophthalmic examination. These studies present an opportunity to investigate the rates of uveitis in MS patients.
All patients who participated in fingolimod trials for relapsing or primary progressive MS and received one or more treatment doses in any of the studies were included in the analyses. Patients excluded due to protocol deviation in any trial were not included. Prevalence and incidence rate/100 patient-years in patients with/without a history of uveitis were determined.
A total of 24,785 patients from the fingolimod trials were analysed: mean age, 39.8 years; women, 70%; Caucasian, 70%. Fingolimod treatment was administered to all patients. 22040 received fingolimod as first assigned treatment in randomized or open label studies while 1120 patients were randomised to IFN beta 1a and 1531 patients to placebo before being switched to fingolimod in the extension phase. The mean observation period was 594 days with a total of 40156 patient years. History of uveitis was reported in 153/24691 patients (prevalence rate: 0.62). 36 patients developed uveitis during the observation period, as a first event in 27 patients (incidence rate: 0.07/100 patient-years) and as a recurrent event in 9 patients. Uveitis occurred at any time during the course of the studies.The incidence of uveitis between MS subtypes were as follows: relapsing remitting, 0.12% and primary progressive, 0.21%; no significant difference was observed.
This is the first report on uveitis incidence in a large prospective MS cohort. Incidence of uveitis in MS patients was consistent between the different subtypes of MS, and occurred at any time point following MS diagnosis. Overall incidence and prevalence of uveitis in this study were low compared with previous reports. Recruitment bias and/or fingolimod treatment effect cannot be excluded.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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