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

H Hammer; N Kamber; M Pistor; L Diem; C Friedli; A Chan; R Hoepner; A Salmen

doi:10.1016/j.msard.2022.104015

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

Mult Scler Relat Disord. 2022 Sep:65:104015. doi: 10.1016/j.msard.2022.104015. Epub 2022 Jul 3.

Authors

H Hammer¹, N Kamber², M Pistor², L Diem², C Friedli², A Chan², R Hoepner², A Salmen²

Affiliations

¹ Department of Neurology, Inselspital, Bern University Hospital and University of Bern, Freiburgstrasse, Bern, Switzerland. Electronic address: helly.hammer@insel.ch.
² Department of Neurology, Inselspital, Bern University Hospital and University of Bern, Freiburgstrasse, Bern, Switzerland.

PMID: 35810719
DOI: 10.1016/j.msard.2022.104015

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: Agranulocytosis; Anti-CD20; CD20; Leukopenia; MS; Monoclonal antibodies; Multiple sclerosis; Rituximab.

Publication types

Letter

MeSH terms

Adverse Drug Reaction Reporting Systems
Antibodies, Monoclonal, Humanized
Drug-Related Side Effects and Adverse Reactions* / epidemiology
Female
Humans
Male
Multiple Sclerosis*
Neutropenia* / chemically induced
Neutropenia* / epidemiology
United States / epidemiology
United States Food and Drug Administration

Substances

Antibodies, Monoclonal, Humanized
ocrelizumab