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Advances in Therapy
Published in: Advances in Therapy 3/2021

Open Access 01-03-2021 | Multiple Sclerosis | Original Research

A Prospective, Observational, Cohort Study to Assess the Efficacy and Safety of Prolonged-Release Fampridine in Cognition, Fatigue, Depression, and Quality of Life in Multiple Sclerosis Patients: The FAMILY Study

Authors: Dimos D. Mitsikostas, Triantafyllos Doskas, Stylianos Gkatzonis, Nikolaos Fakas, Maria Maltezou, Dimitrios Papadopoulos, Rania Gourgioti, Panayiotis Mitsias

Published in: Advances in Therapy | Issue 3/2021

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Abstract

Introduction

The efficacy of prolonged-release fampridine (PR-FAM) may extend in multiple sclerosis (MS) beyond walking ability. The objective of this study was to evaluate the effect of PR-FAM treatment on cognition, fatigue, depression, and quality of life (QoL) in adult patients with MS in a real-world setting.

Methods

FAMILY was a multi-center, prospective, observational, real-world cohort study of MS patients receiving PR-FAM in the outpatient setting. Patients were treated as per PR-FAM’s local prescribing information for 6 months. Standardized protocols and questionnaires were used to evaluate changes in cognition (PASAT; Paced Auditory Serial Addition Test), fatigue (MFIS; Modified Fatigue Impact Scale), depression (BDI-II; Beck Depression Inventory-II) and QoL (MusiQoL; MS International Quality-of-Life questionnaire, MSIS-29; Multiple Sclerosis Impact Scale: PHYS and PSYCH subscales) at 3 and 6 months compared to baseline.

Results

In total, 102 eligible patients from 8 sites in Greece were analysed, of whom 92 completed the study and 10 discontinued. At 6 months, PR-FAM treatment resulted in improvements from baseline in PASAT-3′′ (p = 0.044), MFIS (p < 0.001), BDI-II (p < 0.001), MusiQoL (p < 0.001) and MSIS-29-PHYS (p = 0.012) and MSIS-PSYCH (p < 0.001). A positive effect was evident already at 3 months in PASAT-3′′ (ns), MFIS (p = 0.020), BDI-II (p = 0.034), MusiQoL (p = 0.001), MSIS-29-PHYS (ns) and MSIS-29-PSYCH (p < 0.001).

Conclusions

This observational study provides new data to the current literature in support of PR-FAM’s positive effects in cognition, fatigue, depression, and QoL in a large, heterogeneous group of Greek MS patients in the real-world setting.

Trial Registration

ClinicalTrials.gov identifier, NCT03164018.
Appendix
Available only for authorised users
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Metadata
Title
A Prospective, Observational, Cohort Study to Assess the Efficacy and Safety of Prolonged-Release Fampridine in Cognition, Fatigue, Depression, and Quality of Life in Multiple Sclerosis Patients: The FAMILY Study
Authors
Dimos D. Mitsikostas
Triantafyllos Doskas
Stylianos Gkatzonis
Nikolaos Fakas
Maria Maltezou
Dimitrios Papadopoulos
Rania Gourgioti
Panayiotis Mitsias
Publication date
01-03-2021
Publisher
Springer Healthcare
Published in
Advances in Therapy / Issue 3/2021
Print ISSN: 0741-238X
Electronic ISSN: 1865-8652
DOI
https://doi.org/10.1007/s12325-020-01606-5

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