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Published on: February 14, 2011
Cryptococcal Meningitis Reported With Fingolimod Treatment: Case Series.
Maurizio Del Poeta1, Brian J Ward1, Benjamin Greenberg1
1From the Department of Microbiology and Immunology (M.D.P.), Stony Brook University; Division of Infectious Diseases (M.D.P.), School of Medicine, Stony Brook University; Veterans Affairs Medical Center (M.D.P.), Northport, NY; Infectious Diseases Division (B.J.W.), Research Institute of the McGill University Health Centre, Montreal, QC, Canada; University of Texas Southwestern Medical Center (B.G.), Department of Neurology, Dallas, TX; Department of Neurology (B.H.), Klinikum Rechts der Isar, Technical University of Munich; Munich Cluster for Systems Neurology (SyNergy) (B.H.), Germany; UCSF Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Novartis Healthcare Pvt. Ltd. (S.K., J.M.), Hyderabad, India; Novartis Pharmaceuticals Corporation (R.S.), East Hanover, NJ; Novartis Pharma AG (A.K., A.M., T.H.), Basel, Switzerland; and Department of Neurology (J.R.B.), Perelman School of Medicine, University of Pennsylvania, Philadelphia.
Fingolimod (Gilenya) use in multiple sclerosis (MS) patients was associated with cryptococcal meningitis (CM), with an estimated incidence of 8 per 100,000 patient-years. Early detection of CM symptoms like headache is crucial for better outcomes.
Area of Science:
- Neurology
- Infectious Diseases
- Pharmacovigilance
Background:
- Multiple Sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system.
- Fingolimod is an immunomodulatory drug used for MS treatment.
- Cryptococcal meningitis (CM) is a serious fungal infection that can occur in immunocompromised individuals.
Purpose of the Study:
- To characterize patients with MS who developed cryptococcal meningitis (CM) while undergoing fingolimod treatment.
- To estimate the incidence rate of CM in fingolimod-treated MS patients.
Main Methods:
- A retrospective analysis of the Novartis safety database was conducted.
- Cases of CM in patients treated with fingolimod between January 2006 and February 2020 were identified.
- The incidence rate of CM was calculated based on reported cases and patient exposure data.
Main Results:
- Sixty cases of CM were reported, predominantly in the United States.
- The median patient age was 48 years, with 51.8% being female.
- The estimated incidence rate of CM was 8 per 100,000 patient-years, with a potential increase noted with longer treatment duration.
Conclusions:
- The incidence of CM in fingolimod-treated MS patients is relatively low but warrants vigilance.
- CM mortality in this population is comparable to that in HIV-negative patients.
- Early recognition of CM symptoms (e.g., headache, altered mental status) and prompt treatment are vital for improving patient outcomes.
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