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. 2022 Mar 22;9(3):e1156.
doi: 10.1212/NXI.0000000000001156. Print 2022 May.

Cryptococcal Meningitis Reported With Fingolimod Treatment: Case Series

Maurizio Del Poeta  1 , Brian J Ward  1 , Benjamin Greenberg  1 , Bernhard Hemmer  1 , Bruce A C Cree  1 , Sreelatha Komatireddy  1 , Jitendriya Mishra  1 , Roseanne Sullivan  1 , Ajay Kilaru  1 , Alan Moore  1 , Thomas Hach  1 , Joseph R Berger  2
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Cryptococcal Meningitis Reported With Fingolimod Treatment: Case Series

Maurizio Del Poeta et al. Neurol Neuroimmunol Neuroinflamm. .

Abstract

Background and objectives: To describe the characteristics of patients with MS reporting cryptococcal meningitis (CM) while treated with fingolimod.

Methods: The Novartis safety database was searched for cases with CM between January 26, 2006, and February 28, 2020. The reporting rate of CM was estimated based on the case reports received and exposure to fingolimod in the postmarketing setting during the relevant period.

Results: A total of 60 case reports of CM were identified, mostly from the United States. The median age was 48 years, and 51.8% were women. Most of the patients had recovered or were recovering at the time of final report. A fatal outcome occurred in 13 cases. During the study period, the rate of CM in patients with MS receiving fingolimod was estimated to be 8 per 100,000 patient-years (95% CI: 6.0; 10.0). The incidence of CM seemed to increase with duration of treatment; however, this relationship remains uncertain due to wide CIs and missing data.

Discussion: The causal relationship between fingolimod treatment and CM is not yet fully understood. The CM mortality rate in fingolimod-treated patients is similar to that reported in HIV-negative patients. Vigilance for signs and symptoms of CM in patients receiving fingolimod, particularly the new onset of headaches and altered mental status, is essential. Early diagnosis and treatment are critical to reducing CM-associated mortality.

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Figures

Figure 1
Figure 1. Geographic Distribution of Cryptococcal Meningitis Cases Reported With Fingolimod Treatment
UAE = United Arab Emirates; UK = United Kingdom; US = the United States.
Figure 2
Figure 2. Incidence of CM per 1,000 Patients by Year of Treatment
CM = Cryptococcal meningitis.
See this image and copyright information in PMC

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