Evolution of psoriasis endpoint use

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Intensifying competition in the crowded psoriasis market drives trends in trial endpoints

Psoriasis Area and Severity index (PASI) is the most commonly used measure of skin disease in psoriasis patients. PASI measures the erythema, thickness, and scaling of psoriatic plaques and weights them by the size of the affected area to produce an absolute PASI score. Change in these absolute PASI scores, comparing before and after therapy, are the most commonly used psoriasis clinical trial efficacy endpoints. In these trials the endpoints are defined as the proportion of patients who achieve PASI 50, PASI 75, PASI 90, or PASI 100 which represent 50%, 75%, 90%, and 100% improvement in PASI score respectively. PASI 100 therefore equates to total plaque resolution and fully cleared skin, while lower numbers represent a lower degree of clearance.

As the available therapies treating psoriasis have become more efficacious over time, we could expect trials to use the highest PASI improvement thresholds as their endpoints. Trial designers are motivated to use the most stringent endpoint which the trialled drug could be expected to achieve as such designs provide the most compelling evidence supporting therapy use. This represents a pressure for companies to demonstrate the highest degree of efficacy for their drug, finely balanced against the risk of missing these endpoints.

Using data from the MARS database we have analysed the relative use of different PASI threshold endpoints from 2008-2019. The use of PASI 50/75/90/100 endpoints have been normalised to the number of all trials employing a PASI endpoint in a given year. The readout shown below (Fig. 1) demonstrates that there is an upward trend in the use of the more stringent PASI 90 and PASI 100 endpoints over the past ten years, whereas use of PASI 50 and PASI 75 has decreased.

Use of the least stringent endpoint, PASI 50, can be shown to decrease most rapidly while PASI 75 use, although decreasing, is doing so at a slower rate and remains the most commonly used endpoint. Conversely PASI 90 use has increased rapidly and is approaching the level of PASI 75 use. Finally, PASI 100 use is increasing but remains the least used PASI endpoint, likely due to the difficulty in totally resolving skin plaques. PASI 100 use has however doubled over the past decade as newer biologics offer near curative action. Although PASI 100 is likely to become a required endpoint for trials, PASI 75 and PASI 90 could continue to be used as secondary endpoints. Therefore, although PASI 100 could become the new expected primary endpoint it may not overtake the use of other PASI endpoints according to analyses which use the same methodology as above.

These trends correlate with the introduction of more efficacious biologics and small molecules which have new mechanisms of action, such as anti-IL-17s, anti-IL-23s, and TYK-2 inhibitors. These newer drugs surpass the efficacy of older anti-TNFs, topical therapies, and non-targeted small molecules such as methotrexate.

Changes in psoriasis endpoint use add to a wider story in immunology markets of incremental innovation leading to market maturity, followed by a drive towards commercial and clinical differentiation for increasingly smaller patient populations.


Continue at:  https://www.iqvia.com/blogs/2020/07/evolution-of-psoriasis-endpoint-use

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