AMETYST - Observational Phase IV Study Following the Influence of Intramuscularly Administered Interferon Beta-1a in Patients with Clinically Isolated Syndrome/Clinically Definite Multiple Sclerosis
Abstract
Intramuscular interferon beta-1a (IM IFNβ-1a) exerts positive effect on a number of clinical parameters; it reduces number of relapses and slows down disability progression. Aim: The primary aim of the study is to evaluate quality of life and cognitive functions in patients treated with IM IFNβ-1a using a visual analogue scale (VAS), Short Form Health Survey-36 (SF-36) and Paced Auditory Serial Addition Test (PASAT).
As the secondary aim, the effects on relapse rate and disability progression (Expanded Disability Status Scale, EDSS) are also evaluated. Patient sample and methods: AMETYST is a prospective, observational, non-interventional phase IV study in patients with Clinically Isolated Syndrome (CIS) or Clinically Definitive Multiple Sclerosis (CDMS) involving 14 Centres for the Treatment of Multiple Sclerosis (MS) in the Czech Republic and 10 Centres in the Slovak Republic.
We present an interim analysis of 121 patients who completed 12 months of treatment with IM IFNβ-1a. Results: Sociodemographic data were consistent with the general MS population.
Within the last six months before treatment initiation, 65.3% patients experienced relapse, after six and 12 months of treatment, 9.2% and 14% of patients, respectively, had a relapse. EDSS, both SF-36 domains and quality of life assessment by patients on VAS were stable throughout the treatment (p < 0.05).
VAS evaluation by physicians and PASAT results were statistically significantly better following the treatment (30.0 vs 23.2; p < 0.001 for VAS and 82,7 vs 86,7; p < 0,05 for PASAT). Conclusions: The interim analysis confirmed significant effect of treatment with IM IFNβ -1a on relapse rate reduction and stabilization of patients' clinical status.
Of the quality of life and cognition parameters, the treatment had a positive effect on physician-reported VAS and PASAT. Other evaluated parameters remained stable.