Abstract
Objective
Neutropenia is a rare complication of anti-CD20 treatment, such as Ocrelizumab (OCR)
in Multiple Sclerosis (MS). Using FDA´s Adverse Event Reporting System (FAERS), a
post-marketing, open access pharmacovigilance database, we aimed to identify risk
factors of neutropenia in OCR-treated patients.
Methods
: Data were retrieved from FAERS identifying OCR-treated patients with and without
neutropenia. Only data with OCR as the single suspected product were considered. Multivariable
logistic regression (MLR) analysis was run to study if MS disease course, age, sex
and bodyweight were associated with the risk of neutropenia.
Results
Of 15,313 initial hits, 3177 complete datasets were included in the analysis. MLR
demonstrated that MS disease course was not associated, whereas sex (female sex (reference
male sex) 0.356, 95%CI 0.145–0.875, p = 0.0124), age (years, 0.909, 95%CI 0.875–0.944, p = 7.4105 × 10−7) and bodyweight (kilogram, 0.961, 95%CI 0.935–0.988, p = 0.005) were factors associated with OCR-related neutropenia (Nagelkerkes R2=0.17, n = 3177). No deaths were reported for identified neutropenia cases.
Conclusion
Using FAERS, we identified male sex, younger age and lower bodyweight as factors associated
with OCR-related neutropenia. With the limitations inherent to this open data source,
our data need prospective validation, but elucidate potential factors for a personalized
side effect profiling.
Keywords
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Biography
Hammer H received research support and travel grants within the last 5 years from Biogen, Merck, Roche & Bristol Myers Squibb. All not related to that work.
Biography
Diem L received travel grants from Merck, Biogen, Roche and Bayer Schweiz. She also received advisory honoraria or speaker's honoraria from Biogen, Novartis and Merck. All not related to that work.
Biography
Friedli C has received travel grants from Biogen, travel grants and advisory honoraria from Sanofi Genzyme, as well as speaker honoraria from Biogen, Novartis and Merck, not related to this work. He reports no conflicts of interest related to this manuscript.
Biography
Chan A has received speakers’/board honoraria from Actelion (Janssen/J&J), Almirall, Bayer, Biogen, Celgene (BMS), Genzyme, Merck KGaA (Darmstadt, Germany), Novartis, Roche, and Teva, all for hospital research funds. He received research support from Biogen, Genzyme, and UCB, the European Union, and the Swiss National Foundation. He serves as associate editor of the European Journal of Neurology, on the editorial board for Clinical and Translational Neuroscience and as topic editor for the Journal of International Medical Research.
Biography
Hoepner R received speaker/advisor honorary from Merck, Novartis, Roche, Biogen, Alexion, Sanofi, Janssen, Bristol-Myers Squibb, and Almirall. He received research support within the last 5 years from Roche, Merck, Sanofi, Biogen, Chiesi, and Bristol-Myers Squibb. He also received research grants from the Swiss MS Society und is a member of the Advisory Board of the Swiss MS Society. He also serves as associated editor for Journal of Central Nervous System disease (SAGE Publisher). No conflicts are related to this work.
Biography
Salmen A received speaker honoraria and/or travel compensation for activities with Bristol Myers Squibb, Novartis, Roche, and research support by Baasch Medicus Foundation and the Swiss MS Society. She serves on the Editorial Board of Frontiers in Neurology - Multiple Sclerosis and Neuroimmunology. All not related to this work.
Article info
Publication history
Published online: July 03, 2022
Accepted:
July 1,
2022
Received in revised form:
May 10,
2022
Received:
April 11,
2022
Identification
Copyright
© 2022 Elsevier B.V. All rights reserved.
