Case Study: Making Pharmaceutical History with ARAVA, a PRO Success Story
In March 2003, Aventis Pharmaceuticals Inc. and the Food and Drug Administration (FDA) made history. The FDA and its Arthritis Drugs Advisory Committee reviewed two-year, controlled, clinical trial data and allowed Aventis to make the claim that its drug, Arava® (leflunomide), improves physical function in rheumatoid arthritis (RA) patients. On the same day, the FDA also accepted a new approach that pharmaceutical companies could use in the future to validate such a claim.
Leading factors influencing the FDA’s decision were the results from studies employing two health outcome measures — the SF-36® Health Survey (SF-36) and the Health Assessment Questionnaire (HAQ). The SF-36 is a patient-reported, 36-question, generic measure of health-related quality of life developed by John E. Ware, Jr., PhD, co-founder of QualityMetric Incorporated, now part of Optum. The HAQ was developed by James F. Fries, MD, and colleagues at Stanford University, and was one of the first functional status (disability) measures.