Long-term natalizumab treatment is associated with sustained improvements in quality of life in patients with multiple sclerosis

Abstract

BackgroundMultiple sclerosis (MS) patients experience lower health-related quality of life (HRQoL) than the general population. In clinical trials, natalizumab significantly improved HRQoL and reduced relapse rates and disability progression in patients with relapsing MS. In a 1-year analysis of patients included in the current study, HRQoL improvement occurred within 3 months of natalizumab initiation and continued for 1 year thereafter. However, natalizumab’s long-term efficacy in improving HRQoL has not been studied.MethodsIn this longitudinal, observational, single-arm US study, HRQoL and treatment satisfaction were evaluated in MS patients receiving intravenous natalizumab 300 mg every 4 weeks in clinical settings. Patients completed surveys at baseline and every 6 months for 3 years and reported the following measures: Short Form-12 Version 2 (SF-12v2), Multiple Sclerosis Impact Scale (MSIS-29), and Treatment Satisfaction Questionnaire for Medication.ResultsIn this study, 120 patients completed ≥3 years of natalizumab treatment. Significant HRQoL improvements were evident from baseline to year 3 by increases in SF-12v2 Physical Component Summary (PCS) and Mental Component Summary scores (P<0.01) and decreases in MSIS-29 physical and psychological scores (P<0.0001). Patients with less physical disability (baseline Disease Steps [DS] 0–2) had significant improvement from baseline to year 3 in SF-12v2 PCS (P<0.05) and MSIS-29 physical scores (P<0.05). Physical HRQoL outcomes in patients with baseline DS 3–6 remained stable over 3 years. Treatment satisfaction increased significantly from baseline to year 1 (P<0.0001) and was maintained in the following 2 years.ConclusionPatients reported physical and psychological HRQoL improvements over 3 years of natalizumab treatment, supporting the long-term efficacy of natalizumab in real-world settings. Lower baseline disease activity and earlier treatment were related to better outcomes, indicating the importance of starting natalizumab early in the disease course. Treatment satisfaction increased after natalizumab initiation and remained high over 3 years of treatment.

Impact of natalizumab on quality of life in a real-world cohort of patients with multiple sclerosis: Results from MS PATHS

“…While one cannot exclude the possibility that additional cumulative benefits or loss of benefits could be observed with a longer treatment duration, prior studies have demonstrated a quick onset of action for both natalizumab and ocrelizumab, as well as sustained effects of natalizumab on PROs starting at three months and continuing through three years of follow-up. 8,10,24,35,36 In addition, given that the average (SD) time of followup for both natalizumab and ocrelizumab was 6 (6) months, we do not anticipate that relapses or the use of extended interval dosing would have had a major impact on the study findings. This analysis has several strengths in design, notably, the use of standardized data from a real-world patient cohort, the ability to adjust for use of comedications acting as potential effect modifiers, and the incorporation of several sensitivity analyses aimed at understanding the clinical meaningfulness of the findings.…”

“…Prior studies have consistently demonstrated improvements or stability relative to baseline across physical and psychosocial functioning in natalizumab-treated patients; however, the emphasis has been primarily on PRO instruments measuring fatigue and depression. [6][7][8][24][25][26][27] In one study, natalizumab was reported to exert positive effects on daytime sleepiness via its effect on fatigue. 25 In the current study, the overall impact of natalizumab on sleep disturbance, positive affect and well-being, emotional and behavioral dyscontrol, and participation/satisfaction with social roles and activities appeared to extend beyond what could be driven by its effect on depression and fatigue.…”

The TCR Repertoire Reconstitution in Multiple Sclerosis: Comparing One-Shot and Continuous Immunosuppressive Therapies

“…Two successful RRMS disease-modifying therapies are natalizumab (NTZ), a humanized monoclonal antibody directed against the integrin α4β1 (or Very Late Antigen-4, VLA-4) that prevents the migration of pathogenic T cells into the CNS (4), and AHSCT that resets the immune system and restores immune tolerance by depleting pathogenic adaptive immune cells (5). Both treatments are particularly effective in those patients who have failed previous conventional therapies (6,7).…”

Influence of psychopathological factors and personality traits on the results of the study of quality of life in patients with multiple sclerosis

“…Этот вопрос достаточно хорошо освещен в литературе [6,7,9,[22][23][24][25]. Изменения показателей КЖ по SF-36, связанные с использованием высокоэффективных методов патогенетического лечения [26][27][28], делает необходимой оценку влияния факторов, не связанных непосредственно с клиническими проявлениями РС, на результаты тестирований КЖ как одного из вариантов PRO.…”