Emerging Methods for Evaluating the Effectiveness of Intramuscular Interferon Beta-1a for Relapsing-Remitting Multiple Sclerosis

Abstract

Newer outcome-based assessment methods have been developed that complement and improve upon the ability of historical clinical and magnetic resonance imaging (MRI) outcome measures to measure multiple sclerosis (MS) disease activity, patient functionality, treatment efficacy, and the risk of MS disease progression. These newer MS outcome assessments include instruments to evaluate cognitive function and patient quality of life; enhanced measures of disability, such as the Multiple Sclerosis Functional Composite instrument; and newer MRI measures of MS disease activity and neuronal changes, such as permanent T 1 hypointensities and central nervous system atrophy. When utilized in conjunction with standard MS outcome measures, these newer MS outcomes provide a more comprehensive picture of disease status and course and hold promise as tools for use in the development and testing of future MS therapies. The well-established first-line MS therapy intramuscular interferon beta-1a, which has been evaluated using a broad range of assessment methods, was used as a reference MS disease-modifying therapy to provide specific examples of studies utilizing newer evaluation methods. Utilization of evolving disease and assessment measures for patients with MS should improve MS patient diagnosis, treatment decisions, and monitoring of therapy. • Multiple sclerosis (MS) is a chronic, immune-mediated neurologic disease that is associated with progressive patient disability and diminished quality of life (QoL).• Historical clinical outcomes, such as MS relapses, physical disability measures, and magnetic resonance imaging (MRI) endpoints, do not capture important elements of MS, such as the impact of MS and MS therapies on a patient's perceived QoL.• This article provides an overview of several key newer MS patient outcomes, including instruments used to assess MS patient cognition, QoL, composite disability measures, and emerging MRI clinical endpoints.• Newer MS patient outcomes have the potential to improve MS patient care and the development and testing of future therapeutics for the treatment of MS. Summary Points Presented in this ArticleHowever, older measures do not capture the entire impact of the disease (e.g., cognition, upper limb function, etc.) on patient function and well-being. Newer outcome measures are being developed with the purpose of capturing additional aspects of the disease and facilitating a more comprehensive assessment of MS disability, progression, and therapeutic efficacy. The primary purpose of this article is to provide the managed care audience with an overview of the most prominent newer MS measures. The potential benefits of these newer outcomes are illustrated using published clinical data on intramuscular interferon beta-1a (IM IFNβ-1a) as an extensively evaluated, representative first-line MS therapy.

Interferon Beta-1a (AVONEX®) as a Treatment Option for Untreated Patients with Multiple Sclerosis (AXIOM): A Prospective, Observational Study

“…The magnitude of improvement as rated by the patients (between 7.7 and 14.3 points on a 25-point VAS) would appear clinically meaningful, but the relevance of the observed changes for patients cannot be currently assessed. In accordance with the AXIOM trial, the majority of trials with IM IFNb-1a showed a trend towards better quality of life, particularly in the physical domains, or at least a stable quality of life [ 19 , 20 , 21 ].…”

Früherkennung und Diagnostik der Multiplen Sklerose

“…neuen oder sich vergrö-ßernden T2-Läsionen im MRT (Arnold et al 2014;Nixon et al 2014). Es wird zunehmend diskutiert, ob diese Parameter zur adäquaten Erfassung von Verlauf und Therapieerfolg ausreichend sind (Foley et al 2013), denn häufig sind mit einer MS auch neuropsychologische Symptome wie Fatigue und Depression assoziiert (7 Kap. 1).…”