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December 1997

The Quality-of-Life Effects of Interferon Beta-1b in Multiple Sclerosis: An Extended Q-TWiST Analysis

Author Affiliations

From the Frontier Science and Technology Research Foundation Inc, Chestnut Hill, Mass (Dr Schwartz), the Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass (Dr Schwartz), the Rocky Mountain Multiple Sclerosis Center, Englewood, Colo (Ms Coulthard-Morris), the Center for Statistical Science, Brown University, Providence, RI (Dr Cole), and the Department of Neurology, Yale University School of Medicine, New Haven, Conn (Dr Vollmer).

Arch Neurol. 1997;54(12):1475-1480. doi:10.1001/archneur.1997.00550240029009

Background:  A recombinant form of interferon beta-lb (Betaseron) was given Food and Drug Adminstration 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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