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

doi:10.1001/archneur.1997.00550240029009

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Vol. 54 No. 12, December 1997

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The Quality-of-Life Effects of Interferon Beta-1b in Multiple Sclerosis

An Extended Q-TWiST Analysis

Carolyn E. Schwartz, ScD; Linda Coulthard-Morris, MA; Bernard Cole, PhD; Timothy Vollmer, MD

Arch Neurol. 1997;54(12):1475-1480.

Abstract

Background
A recombinant form of interferon beta-lb (Betaseron) was givenFood and Drug Adminstration approval for use in the treatmentof relapsing-remitting multiple sclerosis in 1993 based on adocumented reduction in exacerbation rate. However, its effecton disease progression is less clear. It costs $11 000 per yearand has documented adverse effects such as fatigue, feverlikesymptoms, and depression.

Objectives
To evaluate a recombinant form of interferon beta-1b in thetreatment of relapsing-remitting multiple sclerosis and to discusstreatment trade-offs and comprehensive quality-of-life (QOL)outcomes.

Methods
We present a randomized evaluation of treatment with a recombinantform of interferon beta-1b in 79 patients with multiple sclerosiswho participated in a random allocation lottery and were followedup for 12 months, during which data on QOL and clinical outcomeswere collected. The data were analyzed using the Extended Quality-AdjustedTime Without Symptoms and Toxicity (Q-TWiST) method, which evaluatestreatment trade-offs by incorporating several QOL domains andpatient preferences regarding these domains.

Results
Over the 12 months of follow-up, the case patients reported10.6 months of quality-adjusted time, while the control patientsreported 10.4 months of quality-adjusted time (P=.50).

Conclusions
Thus, the first year of treatment with interferon beta-1b didnot significantly improve or detract from QOL. Results are discussedin terms of acceptable trade-offs depending on the nature oftherapy. Future observational and clinical studies should incorporatemeasures of patient preference.

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).

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