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

Arch Neurol. 1997 Dec;54(12):1475-80. doi: 10.1001/archneur.1997.00550240029009.

Abstract

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Controlled Clinical Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adjuvants, Immunologic / therapeutic use*
  • Adult
  • Female
  • Follow-Up Studies
  • Humans
  • Interferon beta-1a
  • Interferon beta-1b
  • Interferon-beta / therapeutic use*
  • Male
  • Multiple Sclerosis / physiopathology
  • Multiple Sclerosis / therapy*
  • Quality of Life*
  • Quality-Adjusted Life Years
  • Random Allocation
  • Recombinant Proteins
  • Recurrence
  • Treatment Outcome

Substances

  • Adjuvants, Immunologic
  • Recombinant Proteins
  • Interferon beta-1b
  • Interferon-beta
  • Interferon beta-1a