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• BACKGROUND: Fingolimod (Gilenya, Novartis, Basel Switzerland) 0.5 mg orally once-daily is widely used for relapsing-remitting multiple sclerosis. Patients are usually screened four months after starting fingolimod for fingolimod-associated macular oedema (FAME). Large registration trials with stringent eligibility criteria have reported a FAME incidence of 0 - 2.08%.
  
  OBJECTIVES: To determine the real-world incidence of FAME in a London population, and to describe the clinical characteristics and management of confirmed cases.
  
  METHODS: All patients started on fingolimod from September 2012 to September 2018 were referred for ophthalmology clinical examination and macular spectral-domain optical coherence tomography (SD-OCT) at four months after starting treatment. Exclusion criteria were failure to attend or non-gradable OCT images.
  
  RESULTS: Of 228 patients, two had FAME at initial screening, giving an incidence of 0.88% (95% confidence interval 0.10-3.10). Another case emerged subsequently, at 637 days, resulting in a final incidence of 1.32% (95% confidence interval 0.30-3.80). Fingolimod was discontinued in two cases. FAME resolved in all cases within two to 10 months, with no persistent visual loss or symptoms.
  
  CONCLUSIONS: The real-world FAME incidence is consistent with fingolimod registration studies. FAME may have a delayed onset and may be better detected with newer OCT devices.

NHE wrote: ↑Sat May 16, 2020 9:25 am Real-world incidence of fingolimod-associated macular oedema.
Mult Scler Relat Disord. 2020 Apr 28;42:102125.

Novartis wrote:5.4 Macular Edema
Fingolimod increases the risk of macular edema. Perform an examination of the fundus, including the macula in all patients before starting treatment, again 3 to 4 months after starting treatment, and again at any time after a patient reports visual disturbances while on GILENYA therapy.

A dose-dependent increase in the risk of macular edema occurred in the GILENYA clinical development program.

In 2-year double-blind, placebo-controlled studies in adult patients with multiple sclerosis, macular edema with or without visual symptoms occurred in 1.5% of patients (11/799) treated with fingolimod 1.25 mg, 0.5% of patients (4/783) treated with GILENYA 0.5 mg, and 0.4% of patients (3/773) treated with placebo. Macular edema occurred predominantly during the first 3 to 4 months of therapy. These clinical trials excluded patients with diabetes mellitus, a known risk factor for macular edema (see below Macular Edema in Patients with History of Uveitis or Diabetes Mellitus). Symptoms of macular edema included blurred vision and decreased visual acuity. Routine ophthalmological examination detected macular edema in some patients with no visual symptoms. Macular edema generally partially or completely resolved with or without treatment after drug discontinuation. Some patients had residual visual acuity loss even after resolution of macular edema. Macular edema has also been reported in patients taking GILENYA in the postmarketing setting, usually within the first 6 months of treatment.

Continuation of GILENYA in patients who develop macular edema has not been evaluated. A decision on whether or not to discontinue GILENYA therapy should include an assessment of the potential benefits and risks for the individual patient. The risk of recurrence after rechallenge has not been evaluated.

Macular Edema in Patients with History of Uveitis or Diabetes Mellitus

Patients with a history of uveitis and patients with diabetes mellitus are at increased risk of macular edema during GILENYA therapy. The incidence of macular edema is also increased in MS patients with a history of uveitis. In the combined clinical trial experience in adult patients with all doses of fingolimod, the rate of macular edema was approximately 20% in MS patients with a history of uveitis versus 0.6% in those without a history of uveitis.GILENYA has not been tested in MS patients with diabetes mellitus. In addition to the examination of the fundus,including the macula prior to treatment and at 3 to 4 months after starting treatment, MS patients with diabetes mellitus or a history of uveitis should have regular follow-up examinations.