Clinical meaningfulness of complete skin clearance in psoriasis - 21/06/16
, Kim A. Papp, MD, PhD b, c, Mark Lebwohl, MD d, Kristian Reich, MD e, Carle Paul, MD, PhD f, Andrew Blauvelt, MD g, Kenneth B. Gordon, MD h, Cassandra E. Milmont, PhD i, Hema N. Viswanathan, PhD i, Joanne Li, PhD i, Lionel Pinto, PhD i, David J. Harrison, PhD i, Greg Kricorian, MD i, Ajay Nirula, MD, PhD i, Paul Klekotka, MD, PhD iAbstract |
Background |
New psoriasis therapies have increased the ability to achieve skin clearance. However, insufficient evidence exists on the impact of total skin clearance from the patient perspective.
Objective |
We sought to determine if complete skin clearance is clinically meaningful compared with treatment responses without clearance.
Methods |
Pooled data from 3 phase-III trials were used to compare results for patients with complete skin clearance (Psoriasis Area and Severity Index [PASI] 100 or static Physician Global Assessment score 0) with patients without complete skin clearance (PASI 75 to <100 or static Physician Global Assessment score 1) based on Psoriasis Symptom Inventory and Dermatology Life Quality Index.
Results |
Percentages of patients with Psoriasis Symptom Inventory score 0 were 45% for those achieving PASI 100 and 8% for PASI 75 to <100 (P < .001). Respective percentages with Dermatology Life Quality Index score 0/1 were 80% and 55% (P < .001). PASI 100 resulted in incremental improvement over PASI 90 to <100 (incremental differences of 28% for Psoriasis Symptom Inventory score 0 and 18% for Dermatology Life Quality Index score 0). Similar results were observed for static Physician Global Assessment scores 0 versus 1.
Conclusions |
Complete skin clearance represents a clinically meaningful end point and outcome for patients, reflected in experiences of no psoriasis symptoms and no impairment on health-related quality of life.
Le texte complet de cet article est disponible en PDF.Key words : Dermatology Life Quality Index, health-related quality of life, patient-reported outcomes, plaque psoriasis, Psoriasis Area and Severity Index, Psoriasis Symptom Inventory, static Physician Global Assessment
Abbreviations used : DLQI, HRQoL, PASI, PSI, sPGA
Plan
| Funded by Amgen Inc. Jon Nilsen, PhD, of Amgen Inc provided medical writing support. |
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| Disclosure: Dr Strober has served as an advisor, paid speaker, consultant, and/or principle investigator for CORRONA Psoriasis registry, AbbVie, Amgen, Celgene, Dermira, Forard Pharma, Janssen, LEO Pharma, Eli Lilly and Company, Marucho, MEdac, Novartis, Pfizer, Stiefel/GlaxoSmithKline, UCB Pharma, Merk, and XenoPort. Dr Papp has served as an advisor, paid speaker, consultant, and/or principle investigator for Amgen Inc, Anacor, AbbVie, Active Biotech, Allergan, Astellas, Astra-Zenica, Basilea, Bayer, Biogen-Idec, Boehringer-Ingelheim, Celgene, Dermira, Eli Lilly and Company, Forward Pharma, Genentech, GlaxoSmithKline, Janssen, Kyowa, Kythera, LEO Pharma, MSD, Merck-Serono, Novartis, Pfizer, Regeneron, Rigel, Roche, Takeda, and UCB. Dr Lebwohl is an employee of the Mount Sinai Medical Center, which receives research funds from AbGenomics, AbbVie, Amgen Inc, Anacor, Aqua, Canfite Biopharma, Celgene, Clinuvel, Coronado Biosciences, Ferndale, Eli Lilly and Company, Janssen, Biotech, LEO Pharma, Merz, Novartis, Pfizer, Sandoz, Sun Pharmaceuticals, and Valeant. Dr Reich has served as advisor and/or paid speaker for and/or participated in clinical trials sponsored by AbbVie, Amgen Inc, Biogen, Boehringer Ingelheim Pharma, Celgene, Centocor, Covagen, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, LEO Pharma, Eli Lilly and Company, Medac, Merck Sharp & Dohme Corp, Novartis, Ocean Pharma, Pfizer, Regeneron, Takeda, UCB, and XenoPort. Dr Paul has served as consultant and/or investigator for clinical trials sponsored by AbbVie, Amgen Inc, Boehringer Ingelheim, Celgene, GlaxoSmithKline, Janssen Cilag, LEO Pharma, Lilly, Pfizer, Novartis, and Regeneron. Dr Blauvelt has served as a scientific adviser and clinical study investigator for Amgen Inc, AbbVie, Boehringer Ingelheim, Celgene, Dermira, Genentech, Janssen, Eli Lilly and Company, Merck, Novartis, Pfizer, Regeneron, and Sandoz. Dr Gordon has served as an advisor, paid speaker, consultant, and/or principle investigator for Amgen, AbbVie, Eli Lilly and Company, Celgene, Novartis, Pfizer, Janssen, and Regeneron. Drs Milmont, Viswanathan, Li, Pinto, Harrison, Kricorian, Nirula, and Klekotka are employees and shareholders of Amgen Inc. |
Vol 75 - N° 1
P. 77 - juillet 2016 Retour au numéro
Article précédent
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