title: 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.
abstract: BACKGROUND
  Apremilast, an oral phosphodiesterase 4 inhibitor, has an acceptable safety profile and is effective for treatment of plaque psoriasis and psoriatic arthritis.
  
  
  OBJECTIVE
  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.
authors.affiliation: Comprehensive Center for Inflammation Medicine, University Hospital Schleswig-Holstein, Lübeck, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Thaçi
authors.affiliation: Harvard Medical School, Boston, MA, USA.
authors.forename: A
authors.initials: A
authors.lastname: Kimball
authors.affiliation: Skin & Cancer Foundation Inc., St. Vincent's Hospital, The University of Melbourne, Melbourne, Vic., Australia.
authors.forename: P
authors.initials: P
authors.lastname: Foley
authors.affiliation: Centre de Recherche Dermatologique du Québec métropolitain, Québec, QC, Canada.
authors.forename: Y
authors.initials: Y
authors.lastname: Poulin
authors.affiliation: Celgene Corporation, Summit, NJ, USA.
authors.forename: E
authors.initials: E
authors.lastname: Levi
authors.affiliation: Celgene Corporation, Summit, NJ, USA.
authors.forename: R
authors.initials: R
authors.lastname: Chen
authors.affiliation: Wake Forest University School of Medicine, Winston-Salem, NC, USA.
authors.forename: S R
authors.initials: SR
authors.lastname: Feldman
mesh_terms: D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D008603:Mental Health; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D058988:Phosphodiesterase 4 Inhibitors / Q000627:therapeutic use; D011565:Psoriasis / Q000188:drug therapy*; D011788:Quality of Life; D012720:Severity of Illness Index; D013792:Thalidomide / Q000031:analogs & derivatives* / Q000627:therapeutic use; D014938:Work Capacity Evaluation
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D058988:Phosphodiesterase 4 Inhibitors; D013792:Thalidomide; C505730:apremilast