Apremilast, an oral phosphodiesterase 4 inhibitor, improves patient-reported outcomes in the treatment of moderate to severe psoriasis: results of two phase III randomized, controlled trials.
AuthorThaçi, D; Kimball, A; Foley, P; Poulin, Y; Levi, E; Chen, R; Feldman, SR
Source TitleJournal of the European Academy of Dermatology and Venereology
University of Melbourne Author/sFoley, Peter
AffiliationMedicine and Radiology
Document TypeJournal Article
CitationsThaçi, D., Kimball, A., Foley, P., Poulin, Y., Levi, E., Chen, R. & Feldman, S. R. (2017). Apremilast, an oral phosphodiesterase 4 inhibitor, improves patient-reported outcomes in the treatment of moderate to severe psoriasis: results of two phase III randomized, controlled trials.. J Eur Acad Dermatol Venereol, 31 (3), pp.498-506. https://doi.org/10.1111/jdv.13918.
Access StatusOpen Access
Open Access at PMChttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC5363239
BACKGROUND: Apremilast, an oral phosphodiesterase 4 inhibitor, has an acceptable safety profile and is effective for treatment of plaque psoriasis and psoriatic arthritis. OBJECTIVES: To evaluate the impact of apremilast on health-related quality of life (HRQOL), general functioning and mental health using patient-reported outcome (PRO) assessments among patients with moderate to severe plaque psoriasis in the ESTEEM 1 and 2 trials. METHODS: A total of 1255 patients were randomized (2 : 1) to apremilast 30 mg BID or placebo for 16 weeks; all received apremilast through Week 32. PRO assessments included the Dermatology Life Quality Index (DLQI), 36-Item Short-Form Health Survey version 2 mental/physical component summary scores (SF-36v2 MCS/PCS), Patient Health Questionnaire-8 (PHQ-8), EuroQol-5D (EQ-5D) and Work Limitations Questionnaire-25 (WLQ-25). Post hoc analyses examined relationships between Psoriasis Area and Severity Index (PASI) scores and PHQ-8 in the apremilast-treated population at Week 16. RESULTS: Treatment with apremilast improved all HRQOL PROs at Week 16 (vs. placebo), except the SF-36v2 PCS, and improvements were sustained through Week 32. Mean DLQI and SF-36v2 MCS improvements exceeded minimal clinically important differences. Changes at Week 16 in PHQ-8 and PASI were weakly correlated, and only 35.8% of patients who achieved a ≥75% reduction from baseline in PASI score (PASI-75) with apremilast treatment also achieved PHQ-8 scores of 0-4. CONCLUSIONS: Apremilast led to improvements in HRQOL PROs vs. placebo in patients with moderate to severe plaque psoriasis.
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