Correspondence| Volume 65, 104015, September 2022

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Ocrelizumab-related neutropenia: Effects of age, sex and bodyweight using the FDA Adverse Event Reporting System (FAERS)



      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.


      : 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.


      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.


      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.


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      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.


      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.


      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.


      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.


      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.


      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.