ArticleFrontiers in immunology2026
A real-world study of ublituximab based on the WHO-VigiAccess and U.S. food and drug administration's adverse event reporting system databases.
Article in Frontiers in immunology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Objective: The study bridge statistical pharmacovigilance signals to clinically actionable insights by systematically characterizing adverse event (AE) patterns associated with ublituximab and identifying previously unrecognized risks. We aim to establish a quantitative framework to inform real-world safety monitoring protocols and regulatory risk-benefit evaluations. Methods: We systematically analyzed AE reports associated with ublituximab through a comprehensive retrospective study of FAERS and VigiAccess databases (data cutoff: December 29, 2024). Utilizing five validated disproportionality analysis methods-the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), Medicines and Healthcare Products Regulatory Agency algorithm (MHRA), and Multi-Item Gamma Poisson Shrinker (MGPS). Results: Our investigation integrated 2, 245 case reports from the FAERS with 2, 037 entries in VigiAccess database. Signal detection via the ROR and PRR uncovered 52 preferred term (PT)-level signals significantly associated with ublituximab in the FAERS database, corresponding to 20 system organ class (SOCs). Notably, four SOCs - encompassing cardiovascular disorders, vascular pathologies, urinary system conditions, and social environment factors - were identified with disproportionality signals but currently lack documentation in approved prescribing information. We identified 8 frequently reported PTs (hypoaesthesia, fall, gait disturbance, paraesthesia, balance disorder, alopecia, tremor, and somnolence) within the top 50 AEs showed disproportionality signals but remain unlisted in the current drug lable. Conclusion: This study has identified confirmed positive signals associated with ublituximab and revealed potential signals of interest. These findings highlight the need for further regulatory review to assess whether the identified signals justify updates to drug labeling and therapeutic guidelines. Future investigations should build upon the AE signals established in this research, with further investigations warranted to elucidate both the clinical incidence rates of these AEs and their definitive causal relationships with ublituximab.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.