Alice B Gottlieb1, Rebecca Germino2, Vivian Herrera2, Xiangyi Meng2, Joseph F Merola3. 1. Icahn School of Medicine at Mount Sinai, New York, New York, USA, alicegottliebderm@gmail.com. 2. Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA. 3. Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Abstract
BACKGROUND/AIMS: In the treat-to-target era, psoriasis disease activity measures that can be easily performed in routine clinical practice are needed. This retrospective pooled analysis explored cutoff values of the product of the 5-point Investigator's Global Assessment and percentage of affected body surface area (IGA × BSA) correlating with achievement of minimal disease activity (MDA). METHODS: Post hoc analysis of the phase 3 clinical trials ERASURE, FIXTURE, FEATURE, and JUNCTURE was conducted to determine associations between IGA × BSA and 2 MDA definitions (Psoriasis Area and Severity Index [PASI] 90 and Dermatology Life Quality Index [DLQI] 0/1, or PASI score ≤1 or BSA <3%) in patients with moderate-to-severe psoriasis receiving secukinumab 300 mg. For each definition of MDA, a range of possible cutoff values of IGA × BSA was examined at each time point. The optimal cutoff value was determined using Youden index (YI), calculated as (sensitivity + specificity - 1). RESULTS: For MDA defined as PASI 90 and DLQI 0/1, optimal IGA × BSA cutoffs were 2.10 at week 12 (YI, 0.60; sensitivity, 0.78; specificity, 0.82), 1.02 at week 24 (YI, 0.55; sensitivity, 0.73; specificity, 0.82), and 1.00 at week 52 (YI, 0.65; sensitivity, 0.79; specificity, 0.86). For MDA defined as PASI score ≤1 or BSA <3%, optimal IGA × BSA cutoffs were 2.98 at week 12 (YI, 0.91; sensitivity, 0.99; specificity, 0.92), 2.80 at week 24 (YI, 0.94; sensitivity, 0.99; specificity, 0.95), and 3.00 at week 52 (YI, 0.96; sensitivity, 1.00; specificity, 0.96). CONCLUSION: IGA × BSA could be a valid measure highly associated with achievement of MDA.
BACKGROUND/AIMS: In the treat-to-target era, psoriasis disease activity measures that can be easily performed in routine clinical practice are needed. This retrospective pooled analysis explored cutoff values of the product of the 5-point Investigator's Global Assessment and percentage of affected body surface area (IGA × BSA) correlating with achievement of minimal disease activity (MDA). METHODS: Post hoc analysis of the phase 3 clinical trials ERASURE, FIXTURE, FEATURE, and JUNCTURE was conducted to determine associations between IGA × BSA and 2 MDA definitions (Psoriasis Area and Severity Index [PASI] 90 and Dermatology Life Quality Index [DLQI] 0/1, or PASI score ≤1 or BSA <3%) in patients with moderate-to-severe psoriasis receiving secukinumab 300 mg. For each definition of MDA, a range of possible cutoff values of IGA × BSA was examined at each time point. The optimal cutoff value was determined using Youden index (YI), calculated as (sensitivity + specificity - 1). RESULTS: For MDA defined as PASI 90 and DLQI 0/1, optimal IGA × BSA cutoffs were 2.10 at week 12 (YI, 0.60; sensitivity, 0.78; specificity, 0.82), 1.02 at week 24 (YI, 0.55; sensitivity, 0.73; specificity, 0.82), and 1.00 at week 52 (YI, 0.65; sensitivity, 0.79; specificity, 0.86). For MDA defined as PASI score ≤1 or BSA <3%, optimal IGA × BSA cutoffs were 2.98 at week 12 (YI, 0.91; sensitivity, 0.99; specificity, 0.92), 2.80 at week 24 (YI, 0.94; sensitivity, 0.99; specificity, 0.95), and 3.00 at week 52 (YI, 0.96; sensitivity, 1.00; specificity, 0.96). CONCLUSION: IGA × BSA could be a valid measure highly associated with achievement of MDA.
Authors: Zelma C Chiesa Fuxench; Kristina Callis Duffin; Michael Siegel; Abby S Van Voorhees; Joel M Gelfand Journal: J Am Acad Dermatol Date: 2015-11 Impact factor: 11.527
Authors: Catherine D Buzney; Caitlin Peterman; Ami Saraiya; Shiu-chung Au; Nicole Dumont; Ryan Mansfield; Alice B Gottlieb Journal: J Drugs Dermatol Date: 2015-02 Impact factor: 2.114
Authors: A B Gottlieb; C E M Griffiths; V C Ho; M Lahfa; U Mrowietz; D F Murrell; J-P Ortonne; G Todd; R Cherill; I Marks; S Emady-Azar; C F Paul Journal: Br J Dermatol Date: 2005-06 Impact factor: 9.302
Authors: Kristina C Duffin; Kim A Papp; Jerry Bagel; Eugenia Levi; Rongdean Chen; Alice B Gottlieb Journal: J Drugs Dermatol Date: 2017-02-01 Impact factor: 2.114
Authors: Vera M R Heydendael; Phyllis I Spuls; Brent C Opmeer; Corianne A J M de Borgie; Johannes B Reitsma; Wouter F M Goldschmidt; Patrick M M Bossuyt; Jan D Bos; Menno A de Rie Journal: N Engl J Med Date: 2003-08-14 Impact factor: 91.245
Authors: Bruce Strober; Kim A Papp; Mark Lebwohl; Kristian Reich; Carle Paul; Andrew Blauvelt; Kenneth B Gordon; Cassandra E Milmont; Hema N Viswanathan; Joanne Li; Lionel Pinto; David J Harrison; Greg Kricorian; Ajay Nirula; Paul Klekotka Journal: J Am Acad Dermatol Date: 2016-05-17 Impact factor: 11.527
Authors: Diamant Thaçi; Bruce Strober; Kenneth B Gordon; Peter Foley; Melinda Gooderham; Akimichi Morita; Kim A Papp; Lluís Puig; M Alan Menter; Matthew J Colombo; Yedid Elbez; Renata M Kisa; June Ye; Andrew A Napoli; Lan Wei; Subhashis Banerjee; Joseph F Merola; Alice B Gottlieb Journal: Dermatol Ther (Heidelb) Date: 2022-01-13
Authors: J I Silverberg; D Lei; M Yousaf; S R Janmohamed; P P Vakharia; R Chopra; R Chavda; S Gabriel; K R Patel; V Singam; R Kantor; D Y Hsu Journal: J Eur Acad Dermatol Venereol Date: 2020-09-01 Impact factor: 6.166