The quality-of-life effects of interferon beta-1b in multiple sclerosis. An extended Q-TWiST analysis.
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.


OBJECTIVE
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.
Schwartz
C E
CE
Frontier Science and Technology Research Foundation Inc., Chestnut Hill, Mass., USA.
Coulthard-Morris
L
L
Cole
B
B
Vollmer
T
T
D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000328:Adult; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000068556:Interferon beta-1a; D000068576:Interferon beta-1b; D016899:Interferon-beta / Q000627:therapeutic use*; D008297:Male; D009103:Multiple Sclerosis / Q000503:physiopathology / Q000628:therapy*; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D011897:Random Allocation; D011994:Recombinant Proteins; D012008:Recurrence; D016896:Treatment Outcome
D000276:Adjuvants, Immunologic; D011994:Recombinant Proteins; D000068576:Interferon beta-1b; D016899:Interferon-beta; D000068556:Interferon beta-1a