The quality-of-life effects of interferon beta-1b in multiple sclerosis. An extended Q-TWiST analysis
C. E. Schwartz, L. Coulthard-Morris, B. Cole and T. Vollmer
Frontier Science and Technology Research Foundation Inc., Chestnut Hill, Mass., USA.
BACKGROUND: A recombinant form of interferon beta-1b (Betaseron) was given
Food and Drug Administration approval for use in the treatment of
relapsing-remitting multiple sclerosis in 1993 based on a documented
reduction in exacerbation rate. However, its effect on disease progression
is less clear. It costs $11,000 per year and has documented adverse effects
such as fatigue, feverlike symptoms, and depression. OBJECTIVES: To
evaluate a recombinant form of interferon beta-1b in the treatment of
relapsing-remitting multiple sclerosis and to discuss treatment trade-offs
and comprehensive quality-of-life (QOL) outcomes. METHODS: We present a
randomized evaluation of treatment with a recombinant form of interferon
beta-1b in 79 patients with multiple sclerosis who participated in a random
allocation lottery and were followed up for 12 months, during which data on
QOL and clinical outcomes were collected. The data were analyzed using the
Extended Quality-Adjusted Time Without Symptoms and Toxicity (Q-TWiST)
method, which evaluates treatment trade-offs by incorporating several QOL
domains and patient preferences regarding these domains. RESULTS: Over the
12 months of follow-up, the case patients reported 10.6 months of
quality-adjusted time, while the control patients reported 10.4 months of
quality-adjusted time (P = .50). CONCLUSIONS: Thus, the first year of
treatment with interferon beta-1b did not significantly improve or detract
from QOL. Results are discussed in terms of acceptable trade-offs depending
on the nature of therapy. Future observational and clinical studies should
incorporate measures of patient preference.
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