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Improved Diagnostic and Prognostic Tools for Rheumatoid Arthritis: Unmet Needs in a Changing Market
Decision Resources, Inc, March 2005, Pages: 13
According to recent clinical studies, the key to achieving optimal outcomes in rheumatoid arthritis (RA) is to diagnose and treat it as early as possible. The need to develop more-sensitive and more-specific markers for early-stage disease is urgent. While developments in disease-modifying drugs and biologic agents have revolutionized the treatment of RA, enabling physicians to slow disease progression and prevent some joint destruction, diagnostics has lagged behind. Therefore, the challenge in this area of medicine lies almost exclusively in the diagnosis of early-stage RA, which can be accomplished only with novel serological tests, imaging techniques, or RA biomarkers.
This report profiles the efforts under way by a variety of companies in this area of great unmet need.
Business Implications
- The key to avoiding irreversible joint damage and achieving optimal outcomes in rheumatoid arthritis (RA) is early treatment, which necessitates early diagnosis. Although the treatment of RA has been revolutionized in recent years by the introduction of tumor necrosis factor-alpha (TNF-a) inhibitors and more-aggressive treatment with disease-modifying antirheumatic drugs (DMARDs), the current array of diagnostic options falls short in all areas: for detecting early cases, reaching differential diagnosis, and predicting disease severity.
- Rheumatoid factor (RF) traditionally has been the standard serological test, but its poor specificity and sensitivity limit its usefulness. In fact, if a highly specific test were developed, it could replace RF altogether. Researchers are seeking to develop serological tests that are specific for RA in response to the well-recognized unmet need for improving the diagnostic paradigm. Emerging tests include anti-cyclic citrullinated peptide (anti-CCP), anti-RA33 antibodies, antifilaggrin antibodies (AFAs), anticalpastatin antibodies, and hyaluronic acid (HA).
- Companies and institutions that wish to enter the field of RA diagnostics should aim to develop a tool with both strong diagnostic performance (including high specificity, high sensitivity, and a marker that is present in early disease) and high prognostic value. A tool with these capabilities would become indispensable throughout the duration of the disease: from providing a diagnosis at initial presentation to monitoring patient response to treatment in established RA.
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