Risk Acceptance in Multiple Sclerosis Patients on Natalizumab Treatment

Carmen Tur,Manuel Comabella,Ingrid Galán,María Isabel Martín,Mar Tintoré,Jordi Río,Denis Bichuetti,Elisenda Anglada,Pablo Nieto González,Carlos Nos,Jaume Sastre-Garriga,Joaquín Castilló,María Jesús Arévalo,Xavier Montalban,Georgina Arrambide,Ángela Vidal-Jordana,Ralf Andreas Linker

doi:10.1371/journal.pone.0082796

Carmen Tur, Manuel Comabella + Show 15 more

Open Access

https://doi.org/10.1371/journal.pone.0082796

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Abstract

ObjectiveWe aimed to investigate the ability of natalizumab (NTZ)-treated patients to assume treatment-associated risks and the factors involved in such risk acceptance. MethodsFrom a total of 185 patients, 114 patients on NTZ as of July 2011 carried out a comprehensive survey. We obtained disease severity perception scores, personality traits’ scores, and risk-acceptance scores (RAS) so that higher RAS indicated higher risk acceptance. We recorded JC virus status (JCV+/-), prior immunosuppression, NTZ treatment duration, and clinical characteristics. NTZ patients were split into subgroups (A-E), depending on their individual PML risk. Some 22 MS patients on first-line drugs (DMD) acted as controls. ResultsNo differences between treatment groups were observed in disease severity perception and personality traits. RAS were higher in NTZ than in DMD patients (p<0.01). Perception of the own disease as a more severe condition tended to predict higher RAS (p=0.07). Higher neuroticism scores predicted higher RAS in the NTZ group as a whole (p=0.04), and in high PML-risk subgroups (A-B) (p=0.02). In low PML-risk subgroups (C-E), higher RAS were associated with a JCV+ status (p=0.01). Neither disability scores nor pre-treatment relapse rate predicted RAS in either group.ConclusionsRisk acceptance is a multifactorial phenomenon, which might be partly explained by an adaptive process, in light of the higher risk acceptance amongst NTZ-treated patients and, especially, amongst those who are JCV seropositive but still have low PML risk, but which seems also intimately related to personality traits.

Highlights

Multiple sclerosis (MS), an inflammatory-demyelinating disease of the central nervous system (CNS), is the second most frequent cause of disability amongst young adults[1]
Its use has been limited by the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic infection caused by the John Cunningham virus (JCV), which may have fatal consequences in 20% of those affected, or lead to serious disability in 40% of survivors[15]
Due to the high efficacy of NTZ, numerous RRMS patients are reaching the timepoint of two years of treatment and need to face the decision whether to assume a higher PML risk or switch to other second-line drugs, whose efficacy has not been compared to NTZ, which could mean a deterioration of their disease

Summary

Introduction

Multiple sclerosis (MS), an inflammatory-demyelinating disease of the central nervous system (CNS), is the second most frequent cause of disability amongst young adults[1]. An increasing number of new drugs have been tried in patients with RRMS, with encouraging results, showing greater efficacy than conventional first-line disease modifying drugs (DMD)[2,3,4,5,6,7,8,9,10,11,12]. Drastic changes in the therapeutic scenario are to be expected over the few years, which may have an important impact on the natural history of the disease These highly effective drugs are likely to entail some risk of potentially serious - generally infrequent- adverse events that patients will have to assume if they want to benefit from them. It is of the highest importance to know the reasons that can lead to a given patient to decide whether to continue on a given treatment or not

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