title: Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with difficult-to-treat nail and scalp psoriasis: Results of 2 phase III randomized, controlled trials (ESTEEM 1 and ESTEEM 2).
abstract: BACKGROUND
  In the phase III double-blind Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) 1 and 2, apremilast, an oral phosphodiesterase 4 inhibitor, demonstrated efficacy in moderate to severe psoriasis.
  
  
  OBJECTIVE
  We sought to evaluate efficacy of apremilast in nail/scalp psoriasis in ESTEEM 1 and 2.
  
  
  METHODS
  A total of 1255 patients were randomized (2:1) to apremilast 30 mg twice daily or placebo. At week 16, placebo patients switched to apremilast through week 32, followed by a randomized withdrawal phase to week 52. A priori efficacy analyses included patients with nail (target nail Nail Psoriasis Severity Index score ≥1) and moderate to very severe scalp (Scalp Physician Global Assessment score ≥3) psoriasis at baseline.
  
  
  RESULTS
  At baseline, 66.1% and 64.7% of patients had nail psoriasis; 66.7% and 65.5% had moderate to very severe scalp psoriasis in ESTEEM 1 and 2. At week 16, apremilast produced greater improvements in Nail Psoriasis Severity Index score versus placebo; mean percent change: -22.5% versus +6.5% (ESTEEM 1; P < .0001) and -29.0% versus -7.1% (ESTEEM 2; P = .0052). At week 16, apremilast produced greater NAPSI-50 response (50% reduction from baseline in target nail Nail Psoriasis Severity Index score) versus placebo (both studies P < .0001) and ScPGA response (Scalp Physician Global Assessment score 0 or 1) versus placebo (both studies P < .0001). Improvements were generally maintained over 52 weeks in patients with Psoriasis Area and Severity Index response at week 32.
  
  
  CONCLUSIONS
  Baseline randomization was not stratified for nail/scalp psoriasis.
  
  
  CONCLUSIONS
  Apremilast reduces the severity of nail/scalp psoriasis.
authors.affiliation: Oregon Health and Science University, Portland, Oregon. Electronic address: phoeberich@aol.com.
authors.forename: Phoebe
authors.initials: P
authors.lastname: Rich
authors.affiliation: SKiN Centre for Dermatology and Probity Medical Research, Peterborough, Ontario, Canada.
authors.forename: Melinda
authors.initials: M
authors.lastname: Gooderham
authors.affiliation: Sorbonne Paris Cité Université Paris Diderot, Assistance Publique-Hôpitaux de Paris Hôpital Saint-Louis, Paris, France.
authors.forename: Hervé
authors.initials: H
authors.lastname: Bachelez
authors.affiliation: Celgene Corporation, Warren, New Jersey.
authors.forename: Joana
authors.initials: J
authors.lastname: Goncalves
authors.affiliation: Celgene Corporation, Warren, New Jersey.
authors.forename: Robert M
authors.initials: RM
authors.lastname: Day
authors.affiliation: Celgene Corporation, Warren, New Jersey.
authors.forename: Rongdean
authors.initials: R
authors.lastname: Chen
authors.affiliation: Bakersfield Dermatology, Bakersfield, California.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Crowley
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009260:Nail Diseases / Q000188:drug therapy* / Q000473:pathology; D058988:Phosphodiesterase 4 Inhibitors / Q000008:administration & dosage*; D011565:Psoriasis / Q000175:diagnosis* / Q000188:drug therapy*; D018570:Risk Assessment; D012536:Scalp Dermatoses / Q000188:drug therapy* / Q000473:pathology; D012720:Severity of Illness Index; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D058988:Phosphodiesterase 4 Inhibitors; D013792:Thalidomide; C505730:apremilast
keywords: apremilast; nail psoriasis; phosphodiesterase 4 inhibitor; psoriasis; scalp psoriasis; systemic therapy