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Alternate Psoriasis Severity Index Effectively Assesses Disease Activity in Cimzia-treated PsA
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A combination of physician’s global assessment and body surface area can be used as an alternative to the Psoriasis Area and Severity Index for measuring disease activity in patients with psoriatic arthritis who have been treated with certolizumab pegol, according to findings published in the Journal of Rheumatology.
“The Psoriasis Area and Severity Index (PASI) is the most widely used tool for the measurement of skin involvement and is considered the ‘gold standard’ for clinical trials,” Jessica A. Walsh, MD, of the University of Utah, and colleagues wrote. “However, PASI assessments are complex and time-consuming, and can be insensitive in patients with milder forms of psoriasis. … To address these limitations, an alternative outcome measure has been proposed: The product of [physician’s global assessment] and body surface area (PGA×BSA), which has the advantages of being simpler than the PASI and giving meaningful scores regardless of psoriasis severity.”
To assess PGA×BSA as an alternative to PASI in assessing patients with psoriatic arthritis (PsA), the researchers drew data from the phase-3 RAPID-PsA trial, which investigated the efficacy of certolizumab pegol (Cimzia, UCB Pharma), compared with placebo, among patients with active PsA. According to the researchers, among the 409 patients randomized in the trial, 252 demonstrated 3% or more BSA at baseline, with 166 treated with certolizumab pegol and 86 who received placebo. Also, 98 had a PASI score of 10 or more, and 153 had a PASI of less than 10, at baseline.
Outcome measures included whether the PGA×BSA and PASI results were comparable, and whether these outcomes correlated with one another or with the Dermatology Life Quality Index (DLQI).
According to the researchers, among the participants treated with certolizumab pegol, both PGA×BSA and PASI demonstrated similar sensitivities between baseline and week 24. The patients demonstrated a mean improvement of 77.4% as defined by PGA×BSA, and 69% by way of PASI, the researchers wrote. Patients who received placebo demonstrated similar improvements, with 3.2% for PGA×BSA and 6.1% for PASI. The achievement of 75% response criterion was attained in 59% of those treated with the drug, according to PGA×BSA, and 61.4% by way of PASI. Among those who received placebo, the 75% response proportions were 15.1% for both PGA×BSA and PASI.
In addition, cross tabulations showed high concordance between response outcomes for both tools, and the researchers’ analysis revealed strong correlations between both systems at baseline and improvement at week 24.
“PGA×BSA is an outcome measure comparable to PASI and is sensitive to change in skin manifestations of PsA with varying levels of skin severity at baseline (PASI ≥ 10 and PASI < 10),” Walsh and colleagues wrote. “Achievement of 75% improvement in patients with PsA at week 24 was comparable for PGA×BSA and PASI, with similar effect sizes observed for the two measures, when adjusting for baseline values. … In patients with PsA, PGA×BSA may be considered a practical alternative to PASI for the measurement of psoriasis severity and response to therapy.” – by Jason Laday
Disclosure: The researchers report funding from UCB Pharma. Please see the full study for all other relevant financial disclosures.
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