Drug-induced progressive multifocal leukoencephalopathy: Lessons learned from contrasting natalizumab and rituximab

Clinical Pharmacology and Therapeutics
N S VermeerM L De Bruin

Abstract

Progressive multifocal leukoencephalopathy (PML) has been identified as a serious adverse drug reaction (ADR) of several immunomodulatory biologicals. In this study, we contrasted the reporting patterns of PML for two biologicals for which the risk was identified at different points in their lifecycle: natalizumab (before reapproval) and rituximab (nine years postapproval). We found that, apart from the differences in clinical characteristics (age, gender, indication, time to event, fatality), which reflect the diversity in context of use, PML reports for natalizumab were more complete and were received sooner after occurrence. This study serves as an important reminder that spontaneous reports should only be used with great caution to quantify and compare safety profiles across products over time. The observed variability in reporting patterns and heterogeneity of PML cases presents challenges to such comparisons. Lumping uncharacterized PML reports together without taking these differences into account may result in biased comparisons and flawed conclusions about differential safety.

References

Jan 1, 1984·Virchows Archiv. A, Pathological Anatomy and Histopathology·O MatsubaraT Kasuga
Mar 5, 2004·The New England Journal of Medicine·Dan M Roden
Jun 18, 2004·The New England Journal of Medicine·Panagiotis Korantzopoulos, Konstantinos Siogas
Oct 2, 2004·The New England Journal of Medicine·Anne Trontell
Oct 8, 2004·Clinical Pharmacology and Therapeutics·Raymond L Woosley
Jun 11, 2005·The New England Journal of Medicine·Annette Langer-GouldDaniel Pelletier
Jun 11, 2005·The New England Journal of Medicine·B K Kleinschmidt-DeMasters, Kenneth L Tyler
Jun 11, 2005·The New England Journal of Medicine·Gert Van AsschePaul Rutgeerts
Aug 2, 2005·Cancer Treatment Reviews·Eva Kimby
Dec 1, 2006·The New England Journal of Medicine·John P Bilezikian
Aug 1, 2007·Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research·Sundeep KhoslaUNKNOWN American Society for Bone and Mineral Research
Sep 18, 2007·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Antoine ParienteNicholas Moore
Oct 20, 2009·European Journal of Clinical Pharmacology·Carlo PiccinniNicola Montanaro
Feb 9, 2010·Nature Biotechnology·Malorye Allison
Mar 2, 2012·Clinical Pharmacology and Therapeutics·M Vinhas de SouzaG Dal Pan
May 18, 2012·The New England Journal of Medicine·Gary BloomgrenCarmen Bozic
Jul 19, 2012·Journal of Neurology, Neurosurgery, and Psychiatry·Dirk MentzerBrigitte Keller-Stanislawski
Oct 19, 2013·Current Neurology and Neuroscience Reports·Joshua J Chalkley, Joseph R Berger
Aug 8, 2015·Clinical Pharmacology and Therapeutics·A SegecM L De Bruin

❮ Previous
Next ❯

Citations

May 19, 2016·Expert Review of Clinical Immunology·Vikram Bhise, Suhayl Dhib-Jalbut
Oct 21, 2015·Clinical Pharmacology and Therapeutics·P K Honig
Oct 14, 2016·Fundamental & Clinical Pharmacology·Olivier ColinUNKNOWN French Pharmacovigilance Network
Feb 7, 2017·Muscle & Nerve·Rup TandanDiantha B Howard
Nov 22, 2018·Clinical Pharmacology and Therapeutics·Niels S VermeerAna Hidalgo-Simon
Jun 22, 2016·Current Allergy and Asthma Reports·Sarah E HenricksonMildred Kwan
Jul 12, 2018·Therapeutic Innovation & Regulatory Science·Michael W ColopyGreg Ball
Apr 11, 2018·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Hugues MelliezUNKNOWN French Hospital Database on HIV (ANRS-C4)

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.