OBJECTIVE: The effect of adalimumab on patient-reported outcomes (PROs) was evaluated in patients with moderate to severe psoriasis during the initial 16-week, double-blind period of a 52-week, Phase III, multicenter trial. METHODS: Patients were randomized to placebo or adalimumab 80 mg at Week 0 and 40 mg every other week from Week 1 to Week 15. PROs were evaluated throughout the study and included the Dermatology Life Quality Index (DLQI), the Short Form 36 Health Survey (SF-36), the Work Productivity and Activity Impairment Questionnaire-Specific Health Problem (WPAI-SHP), and several patient-rated symptom scales. RESULTS: The adalimumab-treated group reported significantly greater improvements in DLQI total score (p<0.001), SF-36 Physical Component Summary score (p<0.001), and Mental Component Summary score (p<0.001) compared with the placebo-treated group over 16 weeks. Significant differences, favoring adalimumab, were also seen for the DLQI subscale scores (p < 0.001); SF-36 scale scores (p<0.001); WPAI-SHP work impairment (p<0.001), activity limitation (p<0.001), and overall work impairment scores (p<0.001); patient's global assessment of disease severity (p<0.001), psoriasis pain (p<0.001), and psoriasis-related pruritus (p = 0.002). CONCLUSION:Adalimumab was efficacious in improving dermatology-specific and general health-related quality of life, work and activity limitations, and psoriasis-related symptoms in patients with moderate to severe psoriasis over a 16-week period.
RCT Entities:
OBJECTIVE: The effect of adalimumab on patient-reported outcomes (PROs) was evaluated in patients with moderate to severe psoriasis during the initial 16-week, double-blind period of a 52-week, Phase III, multicenter trial. METHODS:Patients were randomized to placebo or adalimumab 80 mg at Week 0 and 40 mg every other week from Week 1 to Week 15. PROs were evaluated throughout the study and included the Dermatology Life Quality Index (DLQI), the Short Form 36 Health Survey (SF-36), the Work Productivity and Activity Impairment Questionnaire-Specific Health Problem (WPAI-SHP), and several patient-rated symptom scales. RESULTS: The adalimumab-treated group reported significantly greater improvements in DLQI total score (p<0.001), SF-36 Physical Component Summary score (p<0.001), and Mental Component Summary score (p<0.001) compared with the placebo-treated group over 16 weeks. Significant differences, favoring adalimumab, were also seen for the DLQI subscale scores (p < 0.001); SF-36 scale scores (p<0.001); WPAI-SHP work impairment (p<0.001), activity limitation (p<0.001), and overall work impairment scores (p<0.001); patient's global assessment of disease severity (p<0.001), psoriasis pain (p<0.001), and psoriasis-related pruritus (p = 0.002). CONCLUSION:Adalimumab was efficacious in improving dermatology-specific and general health-related quality of life, work and activity limitations, and psoriasis-related symptoms in patients with moderate to severe psoriasis over a 16-week period.
Authors: Charlotte D'Mello; Kiarash Riazi; Tai Le; Katarzyna M Stevens; Arthur Wang; Derek M McKay; Quentin J Pittman; Mark G Swain Journal: J Neurosci Date: 2013-09-11 Impact factor: 6.167
Authors: Antoinette I M van Laarhoven; Ineke M van der Sman-Mauriks; A Rogier T Donders; Mathilde C Pronk; Peter C M van de Kerkhof; Andrea W M Evers Journal: J Invest Dermatol Date: 2014-12-01 Impact factor: 8.551
Authors: Jérémy Lambert; Brian B Hansen; Benoit Arnould; Géraldine Grataloup; Isabelle Guillemin; Lise Højbjerre; Martin Strandberg-Larsen; Margaret C Reilly Journal: Patient Date: 2014 Impact factor: 3.883
Authors: Kim A Papp; James Signorovitch; Karthik Ramakrishnan; Andrew P Yu; Shiraz R Gupta; Yanjun Bao; Parvez M Mulani Journal: Clin Drug Investig Date: 2011 Impact factor: 2.859
Authors: Richard G B Langley; Kristian Reich; Vibeke Strand; Steven R Feldman; Carle Paul; Kenneth Gordon; Richard B Warren; Darryl Toth; Enkeleida Nikaï; Baojin Zhu; Orin Goldblum; Emily Edson-Heredia; Hilde Carlier; Russel Burge; Chen-Yen Lin; Kristin Hollister; Matthias Augustin Journal: Qual Life Res Date: 2019-10-26 Impact factor: 4.147