ArticleExpert opinion on drug safety2016
Detection of cases of progressive multifocal leukoencephalopathy associated with new biologicals and targeted cancer therapies from the FDA's adverse event reporting system.
Article in Expert opinion on drug safety, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers.
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
43 citing papers in PubMed, 88 citations in OpenAlex.
- Posterior Reversible Encephalopathy Syndrome with Angiogenesis Inhibitors for Solid Tumours: Clues from a Disproportionality Analysis of the FDA Adverse Event Reporting System and Pharmacodynamics.Targeted oncology · 2026Article
- Article
- JC Polyomavirus Infection: A Narrative Review.Infectious diseases and therapy · 2025Review
- Single-Agent and Associated Therapies with Monoclonal Antibodies: What About Follicular Lymphoma?Cancers · 2025Review
- Disproportionality analysis of drug-associated progressive multifocal leukoencephalopathy: roles of underlying diseases and immunomodulatory therapies in FAERS.Frontiers in immunology · 2025Article
- Neutrophils unveiled in chronic lymphocytic leukemia.Frontiers in immunology · 2025Review
- Consensus Statements on Assessments and Vaccinations Prior to Commencement of Advanced Therapies for the Treatment of Inflammatory Bowel Diseases.Alimentary pharmacology & therapeutics · 2025Article
- Progressive multifocal leukoencephalopathy following obinutuzumab and bendamustine therapy for follicular lymphoma: case report and literature review.Acta neurologica Belgica · 2024Article
- Progressive multifocal leukoencephalopathy reports in rheumatoid arthritis concerning different treatment patterns-an exploratory assessment using the food and drug administration adverse event reporting system.Frontiers in drug safety and regulation · 2024Article
- Progressive Multifocal Leukoencephalopathy: Pathogenesis, Diagnostic Tools, and Potential Biomarkers of Response to Therapy.Neurology · 2023Review
- Article
- Nationwide Laboratory Surveillance of Progressive Multifocal Leukoencephalopathy in Japan: Fiscal Years 2011-2020.Viruses · 2023Article
- Progressive Multifocal Leukoencephalopathy in a Patient with Multifocal Neurological Manifestations Caused by Solitary Brainstem Involvement.Internal medicine (Tokyo, Japan) · 2023Article
- Progressive multifocal leukoencephalopathy, advanced ductal breast carcinoma, systemic sclerosis, and checkpoint inhibitors: a therapeutic dilemma.Journal of neurovirology · 2023Article
- Co-InfectionInfection and drug resistance · 2023Article
- Progressive Multifocal Leukoencephalopathy in B-CLL Successfully Treated With Venetoclax and Pembrolizumab.HemaSphere · 2022Article
- Pembrolizumab treatment of inflammatory progressive multifocal leukoencephalopathy: a report of two cases.Journal of neurovirology · 2022Article
- Adverse Effects of Immunosuppression: Infections.Handbook of experimental pharmacology · 2022Article
- Belimumab or anifrolumab for systemic lupus erythematosus? A risk-benefit assessment.Frontiers in immunology · 2022Review
- Progressive multifocal leukoencephalopathy genetic risk variants for pharmacovigilance of immunosuppressant therapies.Frontiers in neurology · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
Abstract
objectiveTo identify and summarize FDA's Adverse Event Reporting System (FAERS) cases of progressive multifocal leukoencephalopathy (PML) associated with biological and targeted cancer therapies (BTCT) that were approved between 2009 and 2015.
methodsFAERS was searched using each BTCT name as primary or secondary suspect drug and the adverse reaction of PML. Among BTCTs with >2 case reports of PML, proportional reporting ratios (PRR) and 95% confidence intervals (CI) were calculated.
resultsAmong 49 new BTCTs, 82 cases of PML were found for 16 drugs. Significant PRR signals were found among 7 (14.6%) BTCTs including: brentuximab (24.5, CI:14.8-40.6), ofatumumab (16.3, CI:9.6-27.4), alemtuzumab (9.9, CI:6.0-16.4), obinutuzumab (7.4, CI:2.4-22.8), ibrutinib (5.6 CI:3.0-10.5), belimumab (4.5 CI:2.3-9.0), and idelalisib (4.1, CI:1.3-12.6). Among the 82 cases with significant signals, confirmation of the diagnosis of PML using objective criteria was found in 56% of the cases. A limitation of FAERS data is that missing data are common.
conclusionsWhen using BTCTs, clinicians and patients consider the risk of PML versus the therapeutic benefit, particularly when used in combination with other drugs which may cause PML, such as rituximab. It is important to recognize that PML may occur in some conditions, such as chronic lymphocytic leukemia, regardless of drug therapy.
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.