PURPOSE: To report outcomes of ophthalmic evaluations in clinical studies of patients receiving fingolimod (Gilenya) for multiple sclerosis (MS).
DESIGN: Analysis done on pooled safety data (N = 2615, all studies group) from 3 double-masked, randomized, parallel-group clinical trials (phase 2 core and extension >5 years, and phase 3 FREEDOMS and TRANSFORMS core and extension studies).
PARTICIPANTS: Patients aged 18 to 55 years (18-60 years in phase 2 study) diagnosed with relapsing-remitting MS were included. Patients with diabetes mellitus or macular oedema (M0) at screening were excluded.
INTERVENTION: Participants received fingolimod (0.5/1.25 mg), placebo, or interferon beta for the respective study durations. Ophthalmic examination included detailed eye history (at screening), visual acuity (VA) assessment (How well you can see) assessment, dilated ophthalmoscopy (Looking in your eye with pupil dilated), optical coherence tomography (OCT) (scan of retina to see the thickness of retina), and fluorescein angiography (FA) (looking a blood vessels after you have been given a glowing dye).
MAIN OUTCOME MEASURES: Extensive ophthalmic monitoring was performed for all patients. While being studied, patients with abnormal findings on dilated ophthalmoscopy and OCT compatible with ME were further studied by FA. All locally diagnosed MO cases were centrally reviewed by the retina specialiston the Data and Safety Monitoring Board.
RESULTS: Among 2615 patients assessed, 19 confirmed MO cases were observed in fingolimod-treated groups (0.5 mg: n = 4, 0.3%; 1.25 mg: n = 15, 1.2%). Most patients (n = 13, 68%) presented with blurred vision, decreased VA, or eye pain. Macular oedema (swelling of the macula which is central part of eye) was diagnosed within 3 to 4 months of treatment initiation in most cases (n = 13, 68%); 2 patients had late onset (>12 months) ME. Of the 19 patients with ME, 5 (26%), all treated with fingolimod 1.25 mg, had a history of uveitis (inflammation of the eye) compared with 26 (1%) in the all studies group. In most cases (n = 16, 84%), ME resolved after discontinuing the study drug. Eleven patients required topical anti-inflammatory medications (eye drops). No patient had further vision deterioration.
CONCLUSIONS: Fingolimod 0.5 mg is associated with a low incidence of MO in MS studies. Patients with a history of uveitis may be at an increased risk of developing ME. An ophthalmic examination before initiating fingolimod therapy and regular follow-up eye examinations during fingolimod therapy are recommended.
You have been told about this potential problem with fingolimod treatment and this puts some figures on the is uncommon event using a bigger group size. In American it is edema in British English it is oedema which means swelling and there can be swelling in the macula, which is the bit of the retina where high definition vision is concentrated.
CoI: MouseDoctor None