Risk Acceptance in Multiple Sclerosis Patients on Natalizumab Treatment

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.

Comparative analysis of first-year fingolimod and natalizumab drug discontinuation among Swedish patients with multiple sclerosis

“…The reasons for this difference is unclear, but may, at least for JCV positivity, relate to differences in risk perception. 17 Finally, the degree of disability also affected the pattern of discontinuation rates, with higher disease activity being associated with lower drug survival. In both cohorts this was explained mostly by lack of effect, and to a lesser degree of increased rates of adverse events.…”

Increased Prevalence of Human Polyomavirus JC Viruria in Chronic Inflammatory Rheumatic Diseases Patients in Treatment with Anti-TNF α: A 18 Month Follow-Up Study

“…The incidence of PML in immune-mediated diseases has recently increased as a consequence of an improved use of biologics and other potent immune-modulatory medications (Berger, 2010 ). Few studies are present in literature that demonstrate a real risk of PML development in CIRDs patients whereas several researches have focused on a possible correlation between JCPyV viremia and the biological therapy in patients with multiple sclerosis (MS) and CD (Lavagna et al, 2007 ; Verbeeck et al, 2008 ; Bellizzi et al, 2011 , 2013a , b ; Bharat et al, 2012 ; Comar et al, 2013 ; Iacobaeus et al, 2013 ; Tur et al, 2013 ; Frohman et al, 2014 ). Therefore, it could be interesting to understand whether there is a correlation between biologics administered for CIRDs and the opportunity that the virus escapes from latency, replicates actively and spreads to the brain causing PML.…”

Decision making under uncertainty, therapeutic inertia, and physicians’ risk preferences in the management of multiple sclerosis (DIScUTIR MS)

“…For example, patients at low risk of developing MS progression may prefer to avoid ‘risky’ treatments (as they have low gains while having a risk of developing side effects), whereas high-risk patients would prefer the most effective treatment even if need to take higher risks (as they have a higher chance of having a progression leading to more disability) (Fig. 2 ) [ 24 , 31 ].

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