From the Ectrims site:
http://www.akm.ch/ectrims2006/
Interferon beta-1b 16-year long-term follow-up study: patient-reported outcomes
D. Langdon, G. Ebers, A. Traboulsee, A. Reder, D.S. Goodin, A. Konieczny, C. Miltenburger for the Betaseron/Betaferon LTF Study Group
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Background: Patient-reported outcomes (PRO) and assessment of cognitive function are increasingly recognised as significant contributions to the understanding of the impact that multiple sclerosis (MS) has on patients’ lives, yet very limited data exist. Insights from PRO can improve quality of life (QoL), patient management and treatment response.
The 16-Year Long-Term Follow-up (16-Year LTF) of the original cohort from the interferon beta-1b (IFNB-1b; Betaferon®) pivotal trial, aims to evaluate the long-term effects of IFNB-1b treatment on patient-reported outcomes and cognition, and relate these to clinical and imaging parameters.
Design/Methods: The 16-Year LTF is a multicentre, open-label, observational study that uses cross-sectional data collection from patients having participated in the original pivotal trial.
A comprehensive battery of tests was selected to assess the health-related (HR) QoL and cognitive status of the patients. These included MS-specific PRO questionnaires, such as the Functional Assessment in MS (FAMS) and EuroQoL (EQ-5D).
The results have been analysed according to the length of exposure to treatment over the 16 years, i.e. “always” = IFNB-1b >80% of the time; “ever” = IFNB-1b >10–80% of the time; “never” = IFNB-1b <=10% of the time.
Results: 328 of the original 372 patients (88.2%) have been identified and they are almost equally distributed across the original treatment groups. Analysis of the FAMS total score and trial outcome index (TOI) indicated that patients from the “always” group had an improved score compared with those from the “ever” and “never” groups.
This trend was also seen in the EQ-5D (rating scale and visual analogue scale) total scores. Assessment of EQ-5D subscales demonstrated that more patients from the “always” group reported “No problem in walking about”, “No problem with self-care” and “No problem performing usual activities”. Further PRO and cognition data (currently being analysed) will be presented.
Conclusions: 88.2% of the original patients have been located even after 16 years. Preliminary results indicate that self-reported QoL is better for the “always” patient group compared to the “ever” and “never” groups, and this finding is consistent across different assessments. Furthermore, the FAMS score shows clinically meaningful differences between the groups. These results suggest that early and long-term treatment sustains HRQoL and self-reported functional dependence in patients with MS.