Clinical response and minimal disease activity with the physician global assessment and body surface area tool: Apremilast ESTEEM analysis

Introduction: Improvement in Psoriasis Area and Severity Index (PASI) score is commonly examined in clinical trials of systemic psoriasis treatments, with PASI-50, PASI-75, and PASI-90 considered clinically meaningful (Torres T, Puiq L. Actas Dermosifiliogr. 2015;106:155-157). However, PASI has limitations, including scoring complexity and insensitivity to changes in mild to moderate psoriasis. The product of the static Physician Global Assessment (PGA) and body surface area (BSA; PGAxBSA) could be a simple tool for quantitating psoriasis severity (Walsh JA, et al. J Am Acad Dermatol. 2013;69:931-937); PGAxBSA scores indicative of clinical response and minimal disease activity (MDA) remain to be explored.
Methods: Data from apremilast-treated patients in the ESTEEM studies (NCT01194219/NCT01232283) at Week 16 (n=836) were used to assess PGAxBSA response equivalent to PASI-50, PASI-50 + Dermatology Life Quality Index (DLQI) ≤5, PASI-75, ≥PASI-90, and MDA (defined herein as achievement of ≥PASI-90+DLQI 0 or 1).
Results: Patients (n=202) achieving PASI-50 to <75 had a corresponding median/interquartile range (IQR) PGAxBSA of 18.0/(10.0-30.0) (ESTEEM 1) and 16.0/(8.7-27.0) (ESTEEM 2); PASI-50+DLQI ≤5, 6.0/(2.0-14.4) and 4.1/. Those achieving PASI-75 to <90 had a median/IQR PGAxBSA of 4.8/(3.0-10.0) (ESTEEM 1) and 4.0/(2.2-6.5) (ESTEEM 2); those achieving ≥PASI-90, 1.0/(0.2-2.1) and 1.0/(0.0-3.3), respectively. Patients achieving MDA had median/IQR PGAxBSA of 1.0/(0.0-2.0) and 1.0/(0.0-3.0) in ESTEEM 1 and 2, respectively.
Conclusions: In apremilast-treated patients with psoriasis in the ESTEEM trials, the simple PGAxBSA tool was sensitive to change in disease severity. PGAxBSA was able to measure meaningful clinical response and MDA.

Dr. Alice Gottlieb

Dr. Alice B. Gottlieb, an internationally recognized expert in psoriasis, psoriatic arthritis, and related disorders, received her MD from Cornell Medical School and her PhD from the Rockefeller University, where she studied in the laboratory of Henry Kunkel and was one of the first women admitted to Rockefeller University/Cornell University School of Medicine’s joint MD-PhD program. Her translational research provided the first double-blind, randomized, placebo-controlled study of TNF blockers as monotherapy for moderate to severe psoriasis (published in The Lancet in 2001), which led to multiple TNF blockers being FDA-approved for psoriasis. She has authored over 350 peer-reviewed articles that have appeared in journals such as The Lancet, the New England Journal of Medicine, and Nature: Drug Discovery. She is Professor of Dermatology at New York Medical College’s Metropolitan Hospital Campus in New York City. She is triple boarded in dermatology, rheumatology, and internal medicine.