Background Natalizumab is approved for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS) who have failed firstline treatment or who have highly active disease. The drug has proved highly effective. However, it has been associated with a risk of progressive multifocal leukoencephalopathy (PML).
Purpose To evaluate natalizumab maintenance in our centre and the motives for suspension.
Material and methods Retrospective observational study of RRMS patients treated with natalizumab in the past 5 years in our hospital. Collected data were: age, gender, diagnosis, previous treatments, Expanded Disability Status Scale (EDSS), length of treatment, Ac JCV, adverse reactions, and reasons for beginning and suspending treatment.
Results We analysed 36 patients: 22 women and 14 men. Mean (SD) age of patients: 39.1 (59) years. 12 (33.3%) patients had 2 or more previous medications, 20 (55,5%) had 1 previous medication and 4 (11.1%) had no previous medication. Previous treatment was interferon beta in 16 patients (44.4%), glatiramero in 14 (38,8%) and fingolimod and teriflunomida in 1 patient (2.7%) each. The reasons for starting natalizumab therapy were treatment failure in 27 patients (75%), aggressive disease start in 4 patients (11.1%) and other reasons in 5 patients (13.8%). 20 patients (55.5%) were seropositive to JVC (index value ranged from 0.02 to 3.7), of whom 3 suffered positive seroconversion. Mean (SD) EDSS score was 2.9 (2.04). 6 patients (16.6%) had hypersensitivity reactions, with positive natalizumab antibodies in 2 patients.13 (36.1%) had perfusion reactions. Median duration of treatment was 26 months. 2 patients (5.5%) had progressed in the disease. The main reasons for suspending therapy were risk of developing PML in 9 patients (25%), treatment failure in 4 patients (11.1%), the patient’s wish in 3 (8.3%) cases and other reasons in 2 (5.5%) patients. There were no PML events.
Conclusion The average duration of maintenance of treatment with natalizumab was 26 months; the principal motive for suspension was the risk of PML. Effective scoreboards for PML risk are important and necessary to identify patients at greatest risk, and to be able to minimise the risk.
References and/or Acknowledgements EMA data sheet
Hospital La Princesa Clinical Histories
No conflict of interest.
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