AMETYST - results of an observational phase IV clinical study evaluating the effect of intramuscular interferon beta-1a therapy in patients with clinically isolated syndrome or clinically definite multiple sclerosis
Abstract
Introduction: AMETYST, a prospective, non-interventional phase IV clinical study, evaluating subjective and objective parameters of 3-year intramuscular interferon beta-1a therapy in patients with clinically isolated syndrome or clinically definite multiple sclerosis. Aim: The primary objective of the study was to evaluate the impact of the study treatment on quality of life assessed by the patient using the visual analogue scale (VAS) and 36-item Short Form Health Survey.
Secondary objectives included quality of life assessed using the VAS by the physician, assessment of cognitive functions by the physician using the PASAT test, the occurrence of relapses in the course of the study and the development of clinically definite multiple sclerosis in patients with clinically isolated syndrome, and the evaluation of weekly intramuscular injection administration by patient. Material and methods: The study was conducted in centres specialized in the treatment of multiple sclerosis - 14 sites in the Czech Republic and 10 sites in Slovakia.
A total of 559 patients were enrolled in the study. Clinical parameters were assessed every six months, the other parameters every 12 months.
An analysis of data was performed using descriptive statistic methods. To eliminate the impact of prematurely withdrawn patients on the study results, the data of patients who completed all study visits were analysed separately.
Results: An improvement of the quality of life was detected during the study treatment; however, this improvement was only mild or unconvincing. The quality of life assessed by patient corresponded very well to the quality of life assessed by the physician.
Conclusion: It was confirmed that the treatment has an important effect on relapse rate reduction and stabilization of patients' clinical status, including their cognitive functions.