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

Christoph Kleinschnitz,Gabriele Niemczyk,Colin Wernsdörfer,Karin Rehberg-Weber

doi:10.3390/ijms160715271

Abstract

The efficacy and safety of first-line disease-modifying therapies (DMT) for relapsing-remitting multiple sclerosis (RRMS) has been demonstrated in pivotal, randomized trials, but these studies do not reflect the routine care setting where treatment gaps or switches are common. The Avonex as Treatment Option for Untreated MS Patients (AXIOM) trial assessed the efficacy of newly-initiated intramuscular interferon beta-1a (IM IFNb-1a) after a treatment-free interval, with particular consideration of the previous course of disease and therapy. The AXIOM trial was an open, 12-month, observational, non-interventional study with a retrospective and a prospective part conducted in Germany. RRMS patients with a treatment-free interval of at least three months were included and treated with IFNb-1a for up to 12 months. Relapse rate, disability progression, injection-related parameters and quality of life observed during the prospective part were compared with retrospectively-collected data. Two hundred and thirty five RRMS patients participated in AXIOM. The mean relapse rate decreased from 1.1 in the three months before baseline to 0.2 per quarter during the twelve-month observational period; the Multiple Sclerosis Functional Composite score improved during twelve months of IM IFNb-1a treatment, while the Expanded Disability Status Scale score did not change over the course of this study. Compared to previous DMTs (IM IFNb-1a, subcutaneous IFNb-1a (SC IFNb-1a), SC IFNb-1b, glatiramer acetate), the patients experienced less injection site reactions and flu-like symptoms, with a stated improved quality of life. IM IFNb-1a was effective and well accepted in RRMS patients with no or discontinued previous therapy. These results from the routine care setting may inform optimization of DMT treatment in RRMS, but need confirmation in further studies.

Highlights

Intramuscular interferon beta-1a (IM IFNb-1a, Avonex®), subcutaneous IFNb-1a (SC IFNb-1a, Rebif®), subcutaneous IFNb-1b (SC IFN-beta-1b, Betaferon®, Extavia®) and glatiramer acetate (GA, Copaxone®) are approved first-line disease-modifying therapies (DMT) of relapsing-remitting multiple sclerosis (RRMS)
Each of the approved IFNb preparations for relapsing forms of MS has demonstrated efficacy as measured by reduced relapse rates, delayed progression of disability and reduced number of lesions detected by magnetic resonance imaging (MRI) in pivotal phase III clinical trials [1]
The primary objective of the study was to evaluate the efficacy of newly-initiated IM IFNb-1a treatment in patients with RRMS after a treatment-free interval

Summary

Introduction

Intramuscular interferon beta-1a (IM IFNb-1a, Avonex®), subcutaneous IFNb-1a (SC IFNb-1a, Rebif®), subcutaneous IFNb-1b (SC IFN-beta-1b, Betaferon®, Extavia®) and glatiramer acetate (GA, Copaxone®) are approved first-line disease-modifying therapies (DMT) of relapsing-remitting multiple sclerosis (RRMS). Each of the approved IFNb preparations for relapsing forms of MS has demonstrated efficacy as measured by reduced relapse rates, delayed progression of disability and reduced number of lesions detected by magnetic resonance imaging (MRI) in pivotal phase III clinical trials [1]. Due to factors, such as strict patient selection, adhesion to study protocol and close monitoring of patients’ neurological status, clinical trials do not adequately reflect everyday clinical practice. In a study of patients with high disease activity prior to treatment initiation and good response to IFNb therapy, disease activity rapidly returned to the previous level after discontinuation of IFNb, and every fifth patient experienced a relapse within 30 days [3]

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