Abstract

Health-related quality of life is frequently included in patient-reported outcomes aimed at evaluating the effectiveness of disease-modifying drugs for multiple sclerosis, but recent data about Italian patients are missing. A multicenter observational and cross-sectional study was performed by students of hospital pharmacy to update existing data on quality of life and to correlate it with the pharmacological and medical history of patients. Quality of life (QoL) was assessed using the MS-QoL54 questionnaire, and the pharmacist collected patients’ characteristics, medical and pharmacological history, and Expanded Disability Status Scale (EDSS). Three hundred and forty-nine patients with multiple sclerosis were recruited from 16 centers between May 2018 and June 2019 (median age = 44.1 years; 68.9% women). The composite indexes of physical and mental well-being showed direct correlation with each other (R = 0.826; p < 0.001), and EDSS disability was an independent negative predictor of both indexes (R2 = 35.08% p < 0.001 and R2 = 15.74% p < 0.001, respectively). A trend of association between Physical Health Composite Score and different classes of oral disease-modifying drugs (DMDs) was observed. Our study found a decrease in QoL correlated with teriflunomide, which deserves further investigation. This experience demonstrates that joint action between scientific society and students association can be successful in conducting a no-profit multicenter observational study in a real-world setting.

Highlights

  • The Quality of life (QoL) related to domains of physical function, pain, perception of one’s health and social and sexual functions was significantly lower in patients taking teriflunomide than in those treated with dimethyl fumarate (Figure 4)

  • Our results indicated that the correlation involving physical and mental health scores was even stronger than that previously reported between Expanded Disability Status Scale (EDSS) and QoL

  • Our data confirmed the inverse correlation between EDSS and QoL and the linear correlation between QoL related to physical and mental health. As it regards the impact of different disease-modifying drugs (DMDs) on QoL, our study found that teriflunomide is an independent negative predictor of worse Physical Health Composite Score and that dimethyl fumarate is associated with an improvement in several subscales of MSQoL-54

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Summary

Introduction

In addition to a clinical measure of disability provided by the EDSS, it is important to provide a measure of the QoL perceived by the patient since the disease onset. To this end, generic tools such as the 36-Item Short Form Survey (SF-36) can be used, but in the last decades, several MS-specific tools for QoL evaluation were developed [7]. Several studies evaluated the association between EDSS score, fatigue, dysarthria, the severity of symptoms, urinary incontinence, depression and anxiety, and QoL in MS patients using the MSQoL-54 instrument or other generic tools [10,11,12,13,14]. The design of the study, which originated from joint action between a scientific society and a student association in the field of hospital pharmacy, focused our analysis on patients treated with self-administrable drugs and likely recruited patients with lower disability and higher QoL expectations

Study Design
Patient Characteristics
Data Collection
Statistical Analysis
Results
Discussion
Conclusions
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