Natalizumab-associated adverse reactions in the long-term treatment of Multiple Sclerosis: A Literature Review
Independent thesis Basic level (professional degree), 10 credits / 15 HE creditsStudent thesis
Clinical trial data demonstrated substantial efficacy and a favourable risk-benefit profile of natalizumab. Treatment of natalizumab is however, associated with a rare but severe infection, progressive multifocal leukoencephalopathy (PML). The occurrence of PML has raised concern about the safety of natalizumab and led to therapy restriction due to risk-benefit consideration. It highlights also the importance of more detailed, long-term safety studies and the need for a more comprehensive post-marketing surveillance system in order to be able to identify the potential risks of natalizumab therapy. The aim of this study was to review the available evidence supporting the adverse reactions of natalizumab with emphasize on treatment duration longer than two years in patients with Multiple Sclerosis (MS). Data on long-term efficacy and safety of natalizumab were used to outline the risk- and benefit balance of natalizumab therapy, and to propose the risk management. A literature review was conducted using PubMed-database published between January 1, 2006 and September 15, 2014. Search terms, inclusion-and exclusion criteria were applied in order to obtain the relevant literature. The results showed that natalizumab in association with long-term treatment appeared to be effective, and was able to maintain the disease activity in patients with MS. Data on safety did not show any new concerns in treatment of natalizumab. The risk of PML, however, remains an important safety concern that is not solved at present. The risk factors for PML may be associated with prior use of immunosuppressant, increased duration of natalizumab therapy and positive status of anti-John Cunningham Virus (JCV) antibody. In conclusion clinical vigilance is the most important intervention to identify PML in treated patients. As long as the risk of PML is managed safely, natalizumab is a valuable therapeutic option for treatment of MS.
Place, publisher, year, edition, pages
2014. , 41 p.
Multiple Sclerosis, Natalizumab, Adverse Drug Reactions, Progressive Multifocal Encephalopathy, Clinical Vigilance
Pharmacology and Toxicology
IdentifiersURN: urn:nbn:se:uu:diva-238714OAI: oai:DiVA.org:uu-238714DiVA: diva2:772001
Subject / course
Bachelor of Science Programme in Pharmacy
Brittebo, Eva, Prof.