Real-World Safety Analysis Identifies Undocumented Adverse Events Among Patients With Follicular Lymphoma Treated With Obinutuzumab
Key Clinical Summary
- Population and Design: Large-scale pharmacovigilance analysis of the US FDA FAERS (n = 7,868) and Japan JADER (n = 1,584) databases evaluated adverse events associated with obinutuzumab in FL and CLL.
- Findings: Adverse events reports were higher in FL (31.7%) vs CLL (29.1%); 198 (FAERS) and 39 (JADER) risk signals identified, spanning 16 and 8 organ classes. Notably, 19 (FAERS) and 15 (JADER) adverse events were previously undocumented in prescribing information.
- Clinical Relevance: Blood/lymphatic (20%) and infectious adverse events (18 to 40%) predominated. Findings underscore the need for individualized treatment decisions, comprehensive risk–benefit evaluation, and close event monitoring during obinutuzumab therapy.
Several previously undocumented adverse events (AEs) associated with obinutuzumab, a type II glycosylated anti-CD20 monoclonal antibody used for the treatment of chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL), according to study results published in PLOS One.
Previous research has found obinutuzumab to be efficacious for the treatment of FL and CLL. However, the safety of obinutuzumab remains unknown. Researchers conducted a large-scale pharmacovigilance analysis using the US FDA Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report (JADER) databases to determine the safety of obinutuzumab among patients with FL or CLL.
Researchers identified 7,868 adverse event reports from FAERS and 1,584 from JADER. Reports of adverse events were higher among patients with FL (31.69%) compared with patients with CLL (29.10%).
A total of 198 and 39 risk signals were identified in the FAERS and JADER datasets, respectively, involving 16 and 8 system organ classes. Among the top 30 reported preferred terms, 19 adverse events from FAERS and 15 adverse events from JADER were not listed in the drug’s prescribing information.
Additionally, blood and lymphatic system disorders were the largest proportion of adverse event reports (20.02%), followed by infections and infestations (18.12%) in the FAERS database. While in the JADER database, infections and infestations were the largest portion of adverse event reports (40.20%), then blood and lymphatic system disorders (32.27%).
The researchers concluded, “the use of obinutuzumab should be determined through individualized decisions that take into account the patient’s personal characteristics, disease status, and treatment goals.”
“The results of signal mining indicate that more attention should be paid to the risks of obinutuzumab-related AEs,” they explained.
They added, “Prior to treatment, doctors must comprehensively evaluate the risks and benefits for the patient, devise a rational treatment plan, and closely monitor adverse reactions and therapeutic effects throughout the treatment process.”
Source:
Li X, Liang H, Leng P, Cao Z. Safety assessment of obinutuzumab: Real-world adverse event analysis based on the FAERS and JADER databases from 2013 to 2025. Oliva Damaso N, ed. PLOS One. Published online October 10, 2025. doi:10.1371/journal.pone.0334317
