TY - JOUR
T1 - Cryptococcal Meningitis Reported With Fingolimod Treatment
T2 - Case Series
AU - Del Poeta, Maurizio
AU - Ward, Brian J.
AU - Greenberg, Benjamin
AU - Hemmer, Bernhard
AU - Cree, Bruce A.C.
AU - Komatireddy, Sreelatha
AU - Mishra, Jitendriya
AU - Sullivan, Roseanne
AU - Kilaru, Ajay
AU - Moore, Alan
AU - Hach, Thomas
AU - Berger, Joseph R.
N1 - Publisher Copyright:
© American Academy of Neurology.
PY - 2022/5/22
Y1 - 2022/5/22
N2 - Background and ObjectivesTo describe the characteristics of patients with MS reporting cryptococcal meningitis (CM) while treated with fingolimod.MethodsThe 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.ResultsA 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.DiscussionThe 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.
AB - Background and ObjectivesTo describe the characteristics of patients with MS reporting cryptococcal meningitis (CM) while treated with fingolimod.MethodsThe 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.ResultsA 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.DiscussionThe 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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U2 - 10.1212/NXI.0000000000001156
DO - 10.1212/NXI.0000000000001156
M3 - Article
C2 - 35318259
AN - SCOPUS:85126903462
SN - 2332-7812
VL - 9
JO - Neurology: Neuroimmunology and NeuroInflammation
JF - Neurology: Neuroimmunology and NeuroInflammation
IS - 3
M1 - e1156
ER -