N H Shear1, M Hartmann2, M E Toledo-Bahena3, M Gilbert4, A Katsambas5, R Yao6, Z Popmihajlov7. 1. Division of Dermatology, University of Toronto and Sunnybrook Health Sciences Centre, Toronto, ON, Canada. neil.shear@sunnybrook.ca. 2. Department of Dermatology, University of Heidelberg, Heidelberg, Germany. 3. Department of Pediatric Dermatology, Hospital Infantil de México Federico Gómez, Mexico City, Mexico. 4. Department of Dermatology, Hôpital du Saint-Sacrement du CHU de Québec, Quebec, QC, Canada. 5. Department of Dermatology, University of Athens, Hygeia Hospital, Athens, Greece. 6. Merck & Co., Inc., Kenilworth, NJ, USA. 7. Merck & Co., Inc., Kenilworth, NJ, USA. zoran.popmihajlov@merck.com.
Abstract
PURPOSE: We evaluated the effect of plaque-type psoriasis on health-related quality of life (HRQoL) of patients who received infliximab (IFX) in real-world clinical settings. METHODS: REALITY was a prospective, observational, open-label study of the efficacy and safety of up to 98 weeks of IFX (5 mg/kg infused at weeks 0, 2, 6, and every 8 weeks thereafter) in patients with moderate-to-severe plaque-type psoriasis. Patients with ≥25 % Psoriasis Area Severity Index (PASI) improvement (PASI 25) at week 50 were eligible for the Extended Treatment Phase (treatment to week 98). Inclusion criteria were diagnosis of plaque-type psoriasis, age ≥18 years, decision to start IFX, and patient consent. Key secondary efficacy outcomes included the Dermatologic Life Quality Index (DLQI; mean DLQI scores, attainment of DLQI 0/1), which was analyzed over 98 weeks. Post hoc analyses examined improvement in DLQI and the relationship between PASI and DLQI. RESULTS: In the Treatment Phase, patients (n = 516, 66.0 % men, mean age 46.4 years) had a mean baseline PASI of 18.1. Mean DLQI improved from 12.7 at baseline to 4.7 [mean change (95 % CI); -8.0 (-8.9, -7.1)] at week 50; 64.0 % (229/358) of patients improved by ≥5 DLQI points. At week 50 (n = 362), 37.6 % (95 % CI; 32.7, 42.7) achieved a DLQI of 0. In the Extended Treatment Phase, patients (n = 167, 68.3 % men, mean age 46.6 years) had a mean baseline PASI of 20.4. Mean DLQI improved from 12.3 at baseline to 2.8 at week 98 [mean change (95 % CI); -9.4 (-10.8, -8.0)]; 68.6 % (96/140) of patients improved by ≥5 DLQI points. At week 98 (n = 141), 47.5 % (95 % CI; 39.4, 55.7) achieved a DLQI of 0. CONCLUSIONS: Patients with plaque-type psoriasis who received treatment with IFX for 50 weeks or up to 98 weeks reported substantial HRQoL improvement.
PURPOSE: We evaluated the effect of plaque-type psoriasis on health-related quality of life (HRQoL) of patients who received infliximab (IFX) in real-world clinical settings. METHODS: REALITY was a prospective, observational, open-label study of the efficacy and safety of up to 98 weeks of IFX (5 mg/kg infused at weeks 0, 2, 6, and every 8 weeks thereafter) in patients with moderate-to-severe plaque-type psoriasis. Patients with ≥25 % Psoriasis Area Severity Index (PASI) improvement (PASI 25) at week 50 were eligible for the Extended Treatment Phase (treatment to week 98). Inclusion criteria were diagnosis of plaque-type psoriasis, age ≥18 years, decision to start IFX, and patient consent. Key secondary efficacy outcomes included the Dermatologic Life Quality Index (DLQI; mean DLQI scores, attainment of DLQI 0/1), which was analyzed over 98 weeks. Post hoc analyses examined improvement in DLQI and the relationship between PASI and DLQI. RESULTS: In the Treatment Phase, patients (n = 516, 66.0 % men, mean age 46.4 years) had a mean baseline PASI of 18.1. Mean DLQI improved from 12.7 at baseline to 4.7 [mean change (95 % CI); -8.0 (-8.9, -7.1)] at week 50; 64.0 % (229/358) of patients improved by ≥5 DLQI points. At week 50 (n = 362), 37.6 % (95 % CI; 32.7, 42.7) achieved a DLQI of 0. In the Extended Treatment Phase, patients (n = 167, 68.3 % men, mean age 46.6 years) had a mean baseline PASI of 20.4. Mean DLQI improved from 12.3 at baseline to 2.8 at week 98 [mean change (95 % CI); -9.4 (-10.8, -8.0)]; 68.6 % (96/140) of patients improved by ≥5 DLQI points. At week 98 (n = 141), 47.5 % (95 % CI; 39.4, 55.7) achieved a DLQI of 0. CONCLUSIONS:Patients with plaque-type psoriasis who received treatment with IFX for 50 weeks or up to 98 weeks reported substantial HRQoL improvement.
Entities:
Keywords:
Dermatologic Life Quality Index; Infliximab; Long-term treatment; Patient subgroups; Quality of life
Authors: Andrew A Nelson; Daniel J Pearce; Alan B Fleischer; Rajesh Balkrishnan; Steven R Feldman Journal: J Am Acad Dermatol Date: 2007-11-08 Impact factor: 11.527
Authors: N H Shear; M Hartmann; M Toledo-Bahena; A Katsambas; L Connors; Q Chang; R Yao; K Nograles; Z Popmihajlov Journal: Br J Dermatol Date: 2014-08-13 Impact factor: 9.302
Authors: Alan Menter; Steven R Feldman; Gerald D Weinstein; Kim Papp; Robert Evans; Cynthia Guzzo; Shu Li; Lisa T Dooley; Cynthia Arnold; Alice B Gottlieb Journal: J Am Acad Dermatol Date: 2006-09-06 Impact factor: 11.527
Authors: Christine S Ahn; Cheryl J Gustafson; Laura F Sandoval; Scott A Davis; Steven R Feldman Journal: Am J Clin Dermatol Date: 2013-08 Impact factor: 7.403
Authors: U Mrowietz; K Kragballe; K Reich; P Spuls; C E M Griffiths; A Nast; J Franke; C Antoniou; P Arenberger; F Balieva; M Bylaite; O Correia; E Daudén; P Gisondi; L Iversen; L Kemény; M Lahfa; T Nijsten; T Rantanen; A Reich; T Rosenbach; S Segaert; C Smith; T Talme; B Volc-Platzer; N Yawalkar Journal: Arch Dermatol Res Date: 2010-09-21 Impact factor: 3.017