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Quality of life outcomes in adults with moderate‐to‐severe plaque psoriasis treated with dimethylfumarate ( DMF ): a post hoc analysis of the BRIDGE study
Author(s) -
Kerkhof P.C.M.,
Loewe R.,
Mrowietz U.,
Falques M.,
PauCharles I.,
Szepietowski J.C.
Publication year - 2020
Publication title -
journal of the european academy of dermatology and venereology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.655
H-Index - 107
eISSN - 1468-3083
pISSN - 0926-9959
DOI - 10.1111/jdv.15922
Subject(s) - medicine , dermatology life quality index , placebo , post hoc analysis , psoriasis , psoriasis area and severity index , quality of life (healthcare) , randomized controlled trial , severity of illness , physical therapy , disease , dermatology , pathology , alternative medicine , nursing
Background Psoriasis is a chronic inflammatory skin disease associated with quality of life (QoL) impairment. BRIDGE was a randomized, double‐blind, phase III study comparing the efficacy and safety of dimethylfumarate ( DMF ) with a fixed combination of fumaric acid esters ( FAE ) or placebo for the treatment of moderate‐to‐severe psoriasis. Objectives This post hoc analysis investigated treatment effect on QoL overall and by patient subgroups categorized by disease severity. Week 8 efficacy responses were also investigated as possible predictors of Week 16 Dermatology Life Quality Index ( DLQI ) outcomes. Methods Patients were randomized to receive a maximum daily dose of 720 mg of DMF , FAE (gradual up‐titration) or placebo for 16 weeks. Psoriasis Area Severity Index, Body Surface Area, Physician's Global Assessment and DLQI were assessed at baseline, Weeks 8 and 16. DLQI 0‐1 indicated ‘no effect on patient life’. Associations between baseline severity, Week 16 DLQI and Week 8 efficacy (as observed cases) were also examined. Results At baseline, 671 patients were included in the full analysis set (267 randomized to DMF , 273 to FAE and 131 to placebo). DMF was superior to placebo ( P < 0.001) and not significantly different to FAE regarding Week 16 DLQI outcomes ( P > 0.05). Baseline disease severity did not impact DLQI outcomes at Week 16. In DMF ‐ and FAE ‐treated patients, Week 8 PASI 50/75 responders reported better DLQI responses at Week 16 vs non‐responders ( P < 0.05). Week 8 PASI ≤ 3 and/or PGA 0‐1 responders were also more likely to report DLQI 0‐1 at Week 16 vs non‐responders ( P < 0.05). Conclusion Dimethylfumarate significantly improved DLQI outcomes vs. placebo and was not affected by baseline disease severity. Efficacy responses ( PASI 50/75, PASI ≤3 and PGA 0‐1) as early as Week 8 were predictive of QoL outcomes at Week 16 in DMF ‐ and FAE ‐treated patients.