Impact of natalizumab on cognitive performances and fatigue in relapsing multiple sclerosis: a prospective, open-label, two years observational study.

Pietro Iaffaldano,Emilio Portaccio,Stefano Zoccolella,Maria Pia Amato,Benedetta Goretti,Damiano Paolicelli,Mariangela D'Onghia,Guglielmo Lucchese,Vita Direnzo,Rosa Gemma Viterbo,Michael Platten,Maria Trojano

doi:10.1371/journal.pone.0035843

Pietro Iaffaldano, Emilio Portaccio + Show 10 more

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https://doi.org/10.1371/journal.pone.0035843

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Abstract

Background and ObjectivesNatalizumab reduces the relapse rate and magnetic resonance imaging activity in patients with Relapsing-Remitting Multiple Sclerosis (RRMS). So far the influence of natalizumab on cognitive functions and fatigue in MS remains uncertain. The aim of this prospective, open-label, observational study was to evaluate the possible effects of natalizumab on cognition and fatigue measures in RRMS patients treated for up to two years.MethodsCognitive performances were examined by the Rao's Brief Repeatable Battery (BRB), the Stroop test (ST) and the Cognitive Impairment Index (CII), every 12 months. Patients who failed in at least 3 tests of the BRB and the ST were classified as cognitively impaired (CI). Fatigue Severity Scale (FSS) was administered every 12 months to assess patient's self-reported fatigue. One hundred and 53 patients completed 1 and 2 year-natalizumab treatment, respectively.ResultsAfter 1 year of treatment the percentage of CI patients decreased from 29% (29/100) at baseline to 19% (19/100) (p = 0.031) and the mean baseline values of CII (13.52±6.85) and FSS (4.01±1.63) scores were significantly reduced (10.48±7.12, p<0.0001 and 3.61±1.56, p = 0.008). These significant effects were confirmed in the subgroup of patients treated up to two years.ConclusionsThese results demonstrate that a short-term NTZ treatment may significantly improve cognitive performances and fatigue in RRMS patients.

Highlights

Cognitive Impairment (CI) and fatigue are common features of Multiple Sclerosis (MS), with an estimated prevalence ranging approximately from 40 to 65% of patients [1,2,3,4]
Improvement in measures of information processing speed, verbal memory and verbal learning has been reported in relapsingremitting (RR) MS patients treated with intramuscular Interferon beta (IFNb)-1a [15] compared with placebo
In the subgroup of patients receiving NTZ for two years, the mean Annualized relapse rate (ARR) and the mean Expanded Disability Status Scale (EDSS) score significantly decreased during the treatment (Friedman test: p,0.0001 and p = 0.011, respectively)

Summary

Introduction

Cognitive Impairment (CI) and fatigue are common features of Multiple Sclerosis (MS), with an estimated prevalence ranging approximately from 40 to 65% of patients [1,2,3,4]. Improvement in measures of information processing speed, verbal memory and verbal learning has been reported in relapsingremitting (RR) MS patients treated with intramuscular Interferon beta (IFNb)-1a [15] compared with placebo. IFNb-1b demonstrated to improve visual memory in RRMS [16] and information processing speed in patients with clinically isolated syndrome suggestive of MS [17], and to delay the cognitive decline in patients with secondary progressive MS [18]. The influence of natalizumab on cognitive functions and fatigue in MS remains uncertain The aim of this prospective, open-label, observational study was to evaluate the possible effects of natalizumab on cognition and fatigue measures in RRMS patients treated for up to two years

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Conclusion