Hammer, H; Kamber, N; Pistor, M; Diem, L; Friedli, C; Chan, A; Hoepner, R; Salmen, A (2022). Ocrelizumab-related neutropenia: Effects of age, sex and bodyweight using the FDA Adverse Event Reporting System (FAERS). Multiple Sclerosis and Related Disorders, 65, p. 104015. Elsevier 10.1016/j.msard.2022.104015
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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.
Item Type: |
Journal Article (Further Contribution) |
|---|---|
Division/Institute: |
04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurology |
UniBE Contributor: |
Hammer, Helly Noemi, Kamber, Nicole, Pistor, Maximilian, Diem, Lara, Friedli, Christoph Daniel, Chan, Andrew Hao-Kuang, Hoepner, Robert, Salmen, Anke |
Subjects: |
600 Technology > 610 Medicine & health |
ISSN: |
2211-0348 |
Publisher: |
Elsevier |
Language: |
English |
Submitter: |
Pubmed Import |
Date Deposited: |
12 Jul 2022 11:41 |
Last Modified: |
05 Dec 2022 16:21 |
Publisher DOI: |
10.1016/j.msard.2022.104015 |
PubMed ID: |
35810719 |
Uncontrolled Keywords: |
Agranulocytosis Anti-CD20 CD20 Leukopenia MS Monoclonal antibodies Multiple sclerosis Rituximab |
BORIS DOI: |
10.48350/171268 |
URI: |
https://boris.unibe.ch/id/eprint/171268 |
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