Journal of the American Academy of Dermatology
Position PaperTwo considerations for patients with psoriasis and their clinicians:: What defines mild, moderate, and severe psoriasis? What constitutes a clinically significant improvement when treating psoriasis?☆,☆☆
Section snippets
Severity of psoriasis: A view from the clinic
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Severity of psoriasis: A view from the new drug approval process
To further appreciate the significance of this position paper, it is necessary to understand the current drug approval process for the treatment of psoriasis. First, there are preclinical studies that demonstrate a profile of activity (eg, anti-inflammatory properties, antiproliferative properties, antiangiogenesis properties) which suggests the drug may have an effect on any or all aspects of the clinical manifestations of psoriasis. Phase II safety and dose-ranging trials in normal people or
The complexity of determining what constitutes severe psoriasis: An illustration
This issue can be appreciated by considering which of the following 4 patients has severe psoriasis:
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Patient A: 20% BSA involved with psoriasis
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Patient B: 10% BSA involved with psoriasis
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Patient C: 5% BSA involved with psoriasis
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Patient D: 1% BSA involved with psoriasis
Consider each of these patients with the following caveats:
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Patient A has obvious widespread disease. This person’s disease is recognized by all as severe and therefore must alter the QOL. However, would it still be severe if it was
A QOL-based definition of the severity of psoriasis
Tables I to IV define psoriasis in a fashion that encompasses the patients’ perceptions (the varying ability of patients to accept side effects, the hassle of topical and ultraviolet light (UVL)–based treatments, the costs, and the lack of complete efficacy and toxicity of current treatments14, 15) and the prescribing habits of physicians. It is important to note that if there were an oral medication that worked every time, did not have associated side effects, and did not have
BACKGROUND TO WHAT CONSTITUTES CLINICALLY SIGNIFICANT IMPROVEMENT
The second purpose of this position paper is to bring attention to another important issue: “What constitutes clinically significant improvement (CSI)” in psoriasis? This is important both in clinical practice (medications that do not provide a particular patient a CSI are deemed not effective for that patient) and in regulatory decision-making (the FDA will not approve a treatment that does not provide a CSI). An attempt to define a CSI for clinical trials is a concept that is past due. The
CONCLUSION
Until we understand the molecular basis of psoriasis and have specific curative or consistently remittive therapies, the approving agencies should continue to assess new drug applications and approve those that are safe and demonstrate CSI in one or more end points. It is recognized that this invites approval of agents that will have limited beneficial effects. Perhaps the marketplace will effectively sort out those that are worthwhile from those that are not, but the current health care
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Reprints not available from authors.
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‡Clinicians actively participating in clinical research trials on psoriasis and concerning the issues represented in this article.