De Broe S, Hewitson P, Mcbride A; International Society of Technology Assessment in Health Care. Meeting.

Annu Meet Int Soc Technol Assess Health Care Int Soc Technol Assess Health Care Meet. 2000; 16: 087.

The Rapid Reviews Team, Wessex Institute for Health Research and Development, University of Southampton, SO16 7PX, UK.

Introduction: A review to assess the efficacy, safety and cost-effectiveness of leflunomide (ARAVAO), a new disease modifying drug for rheumatoid arthritis (RA) that is to be licensed in the UK by the end of 1999. Methods: Electronic searches were carried out to identify RCTs, systematic reviews, epidemiological and economic information. Databases searched included Cochrane Library, MEDLINE, Embase, Econlit, HMIC, National Research Register, GEARS, Best Evidence. 35 papers were reviewed; unpublished trials were excluded. Results: Two RCTs (1 Phase II and 1 Phase III) evaluating the safety and efficacy of leflunomide were identified. The Phase III study evaluated the leflunomide dose expected to be recommended for use in the UK. Treatment with leflunomide is effective for the treatment of the symptoms of RA over placebo and is comparable to sulphasalazine in terms of efficacy. However, it has a different pattern of side effects and possibly a more rapid onset for outcome measures. The main changes in adverse effects are for diarrhoea and nausea.Two groups of patients are expected to benefit from leflunomide treatment: RA patients who experience severe side effects and poor toleration of their current disease modifying anti-rheumatic drug (DMARD); and patients who have no severe side effects but who experience minor or no reduction of symptoms. Leflunomide costs about L400 a year more than sulphasalazine. If it produced net benefits equivalent to an increase in utility of more than about 0.02, then the incremental cost per QALY would be less than L20,000. Conclusion: Leflunomide offers an alternative agent for the treatment of RA but is more expensive than the currently available DMARDs, sulfasalazine and methotrexate. Further research should be done to assess the pattern of side effects of this new drug and, consequently, which types of patients with RA would benefit most.

Publication Types:

• Meeting Abstracts

Keywords:

• Antirheumatic Agents
• Arthritis, Rheumatoid
• Clinical Trials as Topic
• Cost-Benefit Analysis
• Costs and Cost Analysis
• Humans
• Isoxazoles
• Methotrexate
• Placebos
• Sulfasalazine
• United States
• economics
• leflunomide
• hsrmtgs

Other ID:

• GWHSR0000085

UI: 102271759

From Meeting Abstracts