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PGAxBSA composite versus PASI: Comparison across disease severities and as therapeutic response measure for Cal/BD foam in plaque psoriasis - 19/06/20

Doi : 10.1016/j.jaad.2020.02.077 
Linda Stein Gold, MD a, , Jes B. Hansen, PhD b, c, Dharm Patel, PhD b, c, Karen A. Veverka, PhD b, c, Bruce Strober, MD, PhD d, e
a Henry Ford Hospital, Detroit, Michigan 
b LEO Pharma Inc, Madison, New Jersey 
c Ballerup, Ballerup, Denmark 
d Yale University, New Haven, Connecticut 
e Central Connecticut Dermatology Research, Cromwell, Connecticut 

Correspondence to: Linda Stein Gold, MD, Henry Ford Health System, 6530 Farmington Rd, West Bloomfield, Michigan 48322.Henry Ford Health System6530 Farmington RdWest BloomfieldMichigan48322

Abstract

Background

The product of the Physician Global Assessment and body surface area (PGA×BSA) is simpler to use than the Psoriasis Area and Severity Index (PASI), which lacks sensitivity in patients with mild psoriasis.

Objective

To compare the PGA×BSA versus the modified PASI (mPASI) for assessing disease severity and therapeutic response to calcipotriol/betamethasone dipropionate (Cal/BD) foam.

Methods

This post hoc analysis evaluated the efficacy of Cal/BD foam in mild, moderate, and severe psoriasis, as assessed by the PGA×BSA and mPASI, using data from 3 randomized controlled trials (NCT01536886, NCT01866163, NCT02132936). Spearman correlation and Bland-Altman plots were used to compare the PGA×BSA with the mPASI.

Results

Proportions of patients receiving Cal/BD foam achieving 75% response for PGA×BSA and mPASI at weeks 1, 2, and 4 were similar and significantly greater than with vehicle (P ≤ .002 at all timepoints); at week 4, mean improvements were 51.0% and 50.7%, respectively. Spearman correlations for mild, moderate, and severe psoriasis were moderate to high between PGA×BSA and mPASI at baseline (r = .51, .72, and .86, respectively; n = 126, 465, and 58, respectively) and high at week 4 (r = .80, .81, and .89, respectively; n = 121, 452, and 58, respectively) (P < .001).

Limitations

Pooled data from different trials were not prespecified for post hoc analysis. Interrater reliability was not assessed.

Conclusion

Pooled data analysis showed that the PGA×BSA and mPASI correlation was higher with increasing psoriasis severity.

Le texte complet de cet article est disponible en PDF.

Key words : body surface area, Cal/BD, extent of disease activity, mPASI, psoriasis, PGA×BSA, Physician Global Assessment, severity

Abbreviations used : BSA, Cal/BD, CI, mPASI, mPASI-75, PASI, PGA, PGA×BSA, PGA×BSA-75, SD


Plan


 Funding sources: Funded by LEO Pharma Inc.
 Disclosure: Dr Stein Gold serves as a consultant, speaker, advisory board participant, or investigator for LEO Pharma Inc, Mayne Pharma, and Taro Pharmaceutical Industries Ltd relevant to the topic. Drs Hansen, Patel, and Veverka are employees of LEO Pharma Inc. Dr Strober serves as a consultant for AbbVie, Almirall, Amgen, Arena, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dermavant, Dermira, Eli Lilly, GlaxoSmithKline, Janssen, Kyowa Hakko Kirin, LEO Pharma Inc, Medac, Meiji Seika Pharma, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi-Genzyme, Sun Pharma, and UCB Pharma; serves as a speaker for AbbVie, Lilly, Janssen, and Ortho Dermatologics; serves as a consultant for Corrona Psoriasis Registry; and serves as an investigator for AbbVie, Corrona Psoriasis Registry, Dermavant, and Dermira.
 IRB approval status: Not applicable.
 Reprints not available from the authors.


© 2020  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 83 - N° 1

P. 131-138 - juillet 2020 Retour au numéro
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