Evaluation of the Physician Global Assessment and Body Surface Area Composite Tool for Assessing Psoriasis Response to Apremilast Therapy: Results from ESTEEM 1 and ESTEEM 2

February 2017 | Volume 16 | Issue 2 | Original Article | 147 | Copyright © 2017

Kristina C. Duffin MD MS,a Kim A. Papp MD PhD,b Jerry Bagel MD,c Eugenia Levi PharmD BCPS,d Rongdean Chen PhD,d and Alice B. Gottlieb MD PhDe

aUniversity of Utah, Salt Lake City, UT bProbity Medical Research and K Papp Clinical Research, Waterloo, ON, Canada cPsoriasis Treatment Center of Central New Jersey, East Windsor, NJ dCelgene Corporation, Summit, NJ eTufts University School of Medicine, Boston, MA

Abstract

BACKGROUND: The Physician Global Assessment and Body Surface Area (PGAxBSA) composite tool is a simple, effective alternative for measuring psoriasis severity. OBJECTIVE: To evaluate the product of PGAxBSA as a sensitive alternative to the Psoriasis Area and Severity Index (PASI) for assessing disease severity and therapeutic response with data collected from the phase 3 ESTEEM 1 and 2 trials. METHODS: This post hoc analysis included 836 patients randomized to apremilast 30 mg BID at baseline (ESTEEM 1, n=562; ESTEEM 2, n=274). Spearman correlation coefficients were used to compare PGAxBSA, PASI, and the Dermatology Life Quality Index (DLQI). Concordance between PGAxBSA and PASI was evaluated for 50%/75%/90% improvement from baseline at week 16. RESULTS: In ESTEEM 1 and 2, PGAxBSA and PASI exhibited significant positive correlations for measuring disease severity at baseline (r≥0.757) and week 16 (r≥0.807). At week 16, ≥79% concordance was observed between PGAxBSA and PASI for 75% and 90% improvement from baseline; greater concordance (>88.0%) was observed using 50% improvement from baseline. At week 16, PGAxBSA and PASI were moderately correlated with DLQI. Limitations: Analysis was limited to patients with baseline BSA ≥10% and static PGA ≥3. CONCLUSIONS: In patients with moderate to severe psoriasis, PGAxBSA is correlated with PASI and sensitive to therapeutic response.

J Drugs Dermatol. 2017;16(2):147-153.

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BACKGROUND

Skin, the largest organ of the human body, provides an outer exible, resilient, and elastic shell as a remarkable physical, chemical, and biological barrier to the environment. Most of the protective, waterproofing, and insulating properties of the skin are conferred by its tightly packed outer layer called stratum corneum (SC). The SC measures approximately 30-50 μm in depth, but can be as thick as 100-120 μm, depending on the anatomical region. SC consists of approximately 30-50 layers of terminally differentiated keratinocytes. The integrity and proper conditioning of the SC play an essential part in maintaining skin’s barrier function. Trans-epidermal water loss (TEWL) and skin hydration are two physical measures routinely used to evaluate skin’s integrity and its overall health.1-7 Quantitative instrumental methods to evaluate TEWL and skin hydration have been developed and are used to assess the efficacy of moisturizers to “repair” damaged skin (ie, improve barrier function). TEWL represents the free diffusion of water vapor through the SC,5,8 while skin conductance re ects SC water content.3,9 Impairment of skin barrier function translates to elevated TEWL values, and has been reported in pathological skin conditions such as atopic dermatitis and psoriasis. TEWL is increased by injuries that damage the uppermost layers of SC (eg, skin abrasion, tape stripping, extraction of lipids from the SC by organic solvents or detergents). In general, an increase in TEWL is paralleled or followed by a decrease in skin hydration. However, in various dermatological conditions the picture can be a bit more complicated, due to a number of factors, such as the presence of local in ammation, infection, or edema. One of the essential therapeutic principles of treating dermatological conditions is to normalize the skin’s level of hydration. A cornerstone of treating numerous pruritic dry skin conditions (eg, atopic or allergic dermatitis, prurigo nodularis, psoriasis, and ichthyosis) is to restore skin hydration through sustained topical application of moisturizers. A

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