title: Efficacy of tofacitinib for the treatment of nail psoriasis: Two 52-week, randomized, controlled phase 3 studies in patients with moderate-to-severe plaque psoriasis.
abstract: BACKGROUND
  Tofacitinib is an oral Janus kinase inhibitor. Efficacy and safety of tofacitinib in patients with moderate-to-severe plaque psoriasis have been demonstrated.
  
  
  OBJECTIVE
  We sought to assess the efficacy of tofacitinib for the treatment of nail psoriasis over a period of 52 weeks.
  
  
  METHODS
  In 2 identical phase 3 studies (OPT Pivotal 1 and 2), patients were randomized 2:2:1 to receive tofacitinib 5 mg, tofacitinib 10 mg, or placebo, twice daily. At week 16, placebo-treated patients were re-randomized to tofacitinib. This post hoc analysis of patients with existing nail psoriasis assessed the Nail Psoriasis Severity Index (NAPSI) score and proportions of patients achieving ≥50% reduction in NAPSI from baseline (NAPSI50), NAPSI75, or NAPSI100.
  
  
  RESULTS
  Baseline mean NAPSI scores for patients treated with tofacitinib 5 mg (N = 487), tofacitinib 10 mg (N = 476), and placebo (N = 233) twice daily were 27.0, 27.3, and 26.9, respectively. At week 16, significantly (all P < .05) more patients receiving tofacitinib 5 mg and tofacitinib 10 mg versus placebo twice daily achieved NAPSI50 (32.8%, 44.2% vs 12.0%), NAPSI75 (16.9%, 28.1% vs 6.8%), and NAPSI100 (10.3%, 18.2% vs 5.1%), respectively. Improvements were sustained to week 52.
  
  
  CONCLUSIONS
  Limitations include discontinuation of clinical nonresponders at week 28.
  
  
  CONCLUSIONS
  Tofacitinib treatment resulted in improvements in nail psoriasis versus placebo at week 16; improvements were maintained over 52 weeks [NCT01276639; NCT01309737].
authors.affiliation: Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Joseph F
authors.initials: JF
authors.lastname: Merola
authors.affiliation: University of Alabama, Birmingham, Alabama.
authors.forename: Boni
authors.initials: B
authors.lastname: Elewski
authors.affiliation: Pfizer Inc, Groton, Connecticut.
authors.forename: Svitlana
authors.initials: S
authors.lastname: Tatulych
authors.affiliation: Pfizer Inc, Groton, Connecticut.
authors.forename: Shuping
authors.initials: S
authors.lastname: Lan
authors.affiliation: Pfizer Inc, New York, New York.
authors.forename: Anna
authors.initials: A
authors.lastname: Tallman
authors.affiliation: Pfizer Inc, Collegeville, Pennsylvania. Electronic address: docmandy78@yahoo.com.
authors.forename: Mandeep
authors.initials: M
authors.lastname: Kaur
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009260:Nail Diseases / Q000150:complications / Q000188:drug therapy*; D010880:Piperidines / Q000627:therapeutic use*; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use*; D011565:Psoriasis / Q000150:complications / Q000188:drug therapy*; D011743:Pyrimidines / Q000627:therapeutic use*; D011758:Pyrroles / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D010880:Piperidines; D047428:Protein Kinase Inhibitors; D011743:Pyrimidines; D011758:Pyrroles; C479163:tofacitinib
keywords: JAK inhibitor; Nail Psoriasis Severity Index; clinical trial; efficacy; nail psoriasis; tofacitinib