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Stronger association of drug-induced progressive multifocal leukoencephalopathy (PML) with biological
Carlo Piccinni1, Chiara Sacripanti, Elisabetta Poluzzi
1Department of Pharmacology, University of Bologna, Bologna, Italy.
Aim:
The aim of the present study was to collect and compare cases of drug-induced PML in order to contribute to the debate about the role of the underlying diseases and/or drug immunosuppression in PML occurrence.
Methods:
We searched for drug-induced PML cases in two international spontaneous adverse drug reaction (ADR) report databases, FDA-AERS and WHO-VigiBase. From MEDLINE, we retrieved case reports and case series containing the MESH term "leukoencephalopathy, progressive multifocal/chemically induced". In order to assess the PML-drug relationship, we analysed drug-reaction pairs in terms of the patients' underlying diseases and co-suspected drugs.
Results:
Overall, 214 cases in FDA-AERS, 118 in WHO-VigiBase and 140 in MEDLINE were collected. Therapeutic groups more frequently involved in PML cases were monoclonal antibodies (MAbs), conventional immunosuppressive drugs and anti-HIV drugs. The most frequent underlying diseases were lymphoproliferative diseases (28%), autoimmune disorders (20%) and transplants (10%). MAbs were more often reported in cases where they were the only suspected drugs, whereas for the other therapeutic groups, concomitant drugs were reported.
Conclusions:
We found a strong relationship between PML and MAbs, especially when used in autoimmune diseases. PML is becoming a crucial issue of MAbs, since they can cause severe ADRs through the imbalance of the immune system. Based on these results, patients treated with MAbs should be carefully monitored for early signs and symptoms of PML.
Insights
Monoclonal antibodies (MAbs) are strongly linked to progressive multifocal leukoencephalopathy (PML), particularly in autoimmune disease patients. Careful monitoring for PML symptoms is crucial for those on MAb therapy due to potential severe adverse drug reactions.
Area of Science:
- Pharmacovigilance
- Neurology
- Immunology
Background:
- Progressive multifocal leukoencephalopathy (PML) is a rare, opportunistic infection of the central nervous system.
- The role of specific drugs and underlying conditions in drug-induced PML requires further investigation.
Purpose of the Study:
- To collect and compare cases of drug-induced PML.
- To analyze the relationship between underlying diseases, immunosuppression, and PML occurrence.
- To evaluate the association between specific drug classes and PML.
Main Methods:
- Searched FDA-AERS and WHO-VigiBase for drug-induced PML cases.
- Retrieved case reports from MEDLINE using the MESH term "leukoencephalopathy, progressive multifocal/chemically induced".
- Analyzed drug-reaction pairs, considering underlying diseases and co-suspected drugs.
Main Results:
- Collected 352 cases from databases and 140 from MEDLINE.
- Monoclonal antibodies (MAbs), conventional immunosuppressants, and anti-HIV drugs were frequently implicated.
- Lymphoproliferative diseases (28%), autoimmune disorders (20%), and transplants (10%) were common underlying conditions.
Conclusions:
- A strong association exists between PML and MAbs, especially in autoimmune disease treatment.
- MAbs can cause severe adverse drug reactions by disrupting immune system balance.
- Close patient monitoring for early PML signs is essential during MAb therapy.
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