Steven R Feldman1, Donald M Bushnell2, Paul A Klekotka3, Michael Scanlon2, Mona L Martin2, Sally W Wade4, Wenjing Yang3, Lionel Pinto3, Leon Kircik5,6,7, Hema N Viswanathan3. 1. a Wake Forest University School of Medicine , Winston-Salem, NC , USA . 2. b Health Research Associates, Inc. , Mountlake Terrace , WA , USA . 3. c Amgen Inc. , Thousand Oaks , CA , USA . 4. d Wade Outcomes Research and Consulting , Salt Lake City , UT , USA . 5. e Icahn School of Medicine , Mount Sinai , NY , USA . 6. f Indiana University School of Medicine , Indianapolis , IN , USA , and. 7. g Physicians Skin Care, PLLC and DermResearch , PLLC , Louisville , KY , USA.
Abstract
INTRODUCTION: In psoriasis clinical trials, treatment success is often defined as achieving a static Physician Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear). Patients with clear versus almost clear skin may experience psoriasis differently. This study assessed whether aggregating these patients underestimates subjective improvements associated with total skin clearance. METHODS: Patients with plaque psoriasis with stable sPGA 0 or 1 currently treated with adalimumab, etanercept, infliximab, or ustekinumab reported Psoriasis Symptom Inventory (PSI) scores for seven days and Dermatology Life Quality Index (DLQI) scores on day 8. The PSI measures psoriasis signs and symptom severity; the DLQI measures the impact of skin disease on quality of life. This analysis compared PSI and DLQI outcomes between patients with sPGA 0 and 1. RESULTS: This study assessed 230 patients: 79 sPGA 0 and 151 sPGA 1. A greater percentage with sPGA 0 than sPGA 1 achieved a total PSI score of 0 ("best"; 61% vs. 5%, p < 0.0001) and DLQI 0 ("no effect"; 79% vs. 24%, p < 0.001). Patients with sPGA 0 reported better scores than sPGA 1 on all other PSI and DLQI assessments. CONCLUSIONS: Achieving total skin clearance, compared with almost clear skin, provides clinically meaningful improvements in psoriasis.
INTRODUCTION: In psoriasis clinical trials, treatment success is often defined as achieving a static Physician Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear). Patients with clear versus almost clear skin may experience psoriasis differently. This study assessed whether aggregating these patients underestimates subjective improvements associated with total skin clearance. METHODS:Patients with plaque psoriasis with stable sPGA 0 or 1 currently treated with adalimumab, etanercept, infliximab, or ustekinumab reported Psoriasis Symptom Inventory (PSI) scores for seven days and Dermatology Life Quality Index (DLQI) scores on day 8. The PSI measures psoriasis signs and symptom severity; the DLQI measures the impact of skin disease on quality of life. This analysis compared PSI and DLQI outcomes between patients with sPGA 0 and 1. RESULTS: This study assessed 230 patients: 79 sPGA 0 and 151 sPGA 1. A greater percentage with sPGA 0 than sPGA 1 achieved a total PSI score of 0 ("best"; 61% vs. 5%, p < 0.0001) and DLQI 0 ("no effect"; 79% vs. 24%, p < 0.001). Patients with sPGA 0 reported better scores than sPGA 1 on all other PSI and DLQI assessments. CONCLUSIONS: Achieving total skin clearance, compared with almost clear skin, provides clinically meaningful improvements in psoriasis.
Entities:
Keywords:
Clinical meaningfulness; Psoriasis Symptom Inventory; moderate to severe plaque psoriasis; patient-reported outcomes; static Physician Global Assessment
Authors: Yan Zhou; Taylor Follansbee; Xuesong Wu; Dan Han; Sebastian Yu; Dan T Domocos; Zhenrui Shi; Mirela Carstens; Earl Carstens; Samuel T Hwang Journal: J Dermatol Sci Date: 2018-11-26 Impact factor: 4.563
Authors: Yan Zhou; Dan Han; Taylor Follansbee; Xuesong Wu; Sebastian Yu; Bo Wang; Zhenrui Shi; Dan T Domocos; Mirela Carstens; Earl Carstens; Samuel T Hwang Journal: J Cell Mol Med Date: 2019-05-21 Impact factor: 5.310
Authors: M Gooderham; A Pinter; L K Ferris; R B Warren; T Zhan; J Zeng; A M Soliman; C Kaufmann; B Kaplan; H Photowala; B Strober Journal: J Eur Acad Dermatol Venereol Date: 2022-03-17 Impact factor: 9.228
Authors: A Blauvelt; K Papp; A Gottlieb; A Jarell; K Reich; C Maari; K B Gordon; L K Ferris; R G Langley; Y Tada; R G Lima; H Elmaraghy; G Gallo; L Renda; S Y Park; R Burge; J Bagel Journal: Br J Dermatol Date: 2020-01-15 Impact factor: 9.302
Authors: Jean-Philippe Lacour; Anthony Bewley; Edward Hammond; Jes B Hansen; Laura Horne; Carle Paul; Kristian Reich; Julien Seneschal; Clara De Simone; Anne Sohrt; Matthias Augustin; Giovanni Pellacani Journal: Dermatol Ther (Heidelb) Date: 2020-08-06