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CLINICAL TRIAL, PHASE III
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
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.
Journal of Drugs in Dermatology : JDD 2017 Februrary 2
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. <p><em>J Drugs Dermatol. 2017;16(2):147-153.</em></p>.
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. <p><em>J Drugs Dermatol. 2017;16(2):147-153.</em></p>.
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