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Adverse event profile differences between rituximab and ocrelizumab: Findings from the FDA Adverse Event Reporting
Natalia Gonzalez Caldito1, Afsaneh Shirani2, Amber Salter3
1Department of Neurology & Neurotherapeutics, Immunology Graduate Program, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Background:
Rituximab and ocrelizumab are anti-CD20 monoclonal antibodies that have shown a marked reduction in multiple sclerosis (MS) inflammatory activity. However, their real-world safety profile has not been adequately compared.
Objective:
To investigate the adverse event (AE) profile of rituximab and ocrelizumab reported to the Food and Drug Administration Adverse Event Reporting System (FAERS) database.
Methods:
The FAERS database was filtered by indication (MS) and drug (rituximab or ocrelizumab). Disproportionality analyses including but not limited to reporting odds ratio (ROR) were conducted to identify drug-AE associations. A signal was detected if the lower limit of the 95% confidence interval of ROR (ROR025) exceeded 1.
Results:
There were 623 and 7948 reports for rituximab and ocrelizumab, respectively. The most frequent AEs with rituximab and ocrelizumab were infusion-related reaction (4.82%) and urinary tract infection (10.52%), respectively. The strongest drug-AE association for rituximab and ocrelizumab were ear pruritus (ROR025: 47.53) and oral herpes (ROR025: 38.99), respectively. Ocrelizumab was associated with an almost two times higher frequency of infections than rituximab (21.93% vs 11.05%, respectively).
Conclusion:
This study revealed differences in reporting AEs between rituximab and ocrelizumab. Infections were reported more frequently with ocrelizumab. Although speculative, a potentially different or more extensive B-cell depletion by ocrelizumab might explain these findings. Additional pharmacovigilance studies need to be performed to better characterize differences in the AE profile in B-cell-depleting therapies.
Insights
Ocrelizumab showed a higher frequency of infections compared to rituximab in multiple sclerosis (MS) patients. Further studies are needed to fully understand the safety profiles of these anti-CD20 therapies.
Area of Science:
- Immunology
- Pharmacology
- Neurology
Background:
- Rituximab and ocrelizumab are anti-CD20 monoclonal antibodies used to reduce inflammatory activity in multiple sclerosis (MS).
- Real-world safety data comparing rituximab and ocrelizumab in MS patients is limited.
Purpose of the Study:
- To compare the adverse event (AE) profiles of rituximab and ocrelizumab.
- To identify specific drug-AE associations using real-world data.
Main Methods:
- Utilized the Food and Drug Administration Adverse Event Reporting System (FAERS) database.
- Filtered reports for MS indication and specific drugs (rituximab or ocrelizumab).
- Conducted disproportionality analyses, including reporting odds ratio (ROR), to detect AE signals (ROR025 > 1).
Main Results:
- Ocrelizumab had a higher overall frequency of infections (21.93%) compared to rituximab (11.05%).
- Most frequent AEs were infusion-related reactions for rituximab and urinary tract infections for ocrelizumab.
- Strongest drug-AE associations included ear pruritus for rituximab and oral herpes for ocrelizumab.
Conclusions:
- Ocrelizumab is associated with a higher reporting rate of infections than rituximab in MS patients.
- Potential differences in B-cell depletion may explain observed safety profile variations.
- Further pharmacovigilance studies are necessary to fully characterize AE differences in B-cell-depleting therapies.
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