title: Efficacy of Tofacitinib for the Treatment of Moderate-to-Severe Chronic Plaque Psoriasis in Patient Subgroups from Two Randomised Phase 3 Trials.
abstract: BACKGROUND
  Tofacitinib is a Janus kinase inhibitor being investigated for the treatment of moderate-to-severe plaque psoriasis. We report efficacy of tofacitinib in patient subgroups based on pooled data from two Phase 3 trials (<span>NCT</span>01276639, <span>NCT</span>01309737).<br />
  
  
  OBJECTIVE
  To assess consistency of treatment effects of tofacitinib versus placebo in subgroups defined by baseline characteristics, and to ascertain whether baseline characteristics are of value in optimizing tofacitinib use.<br />
  
  
  METHODS
  Pooled data from the two trials were used to evaluate &ge;75% reduction in PASI from baseline (PASI75 response) in subgroups defined by age, age at psoriasis onset, gender, race, geographical region, weight, body mass index, diabetes, metabolic syndrome, tobacco/alcohol use, psoriatic arthritis, disease activity, and prior therapy.<br />
  
  
  RESULTS
  Week 16 PASI75 response rates (N=1843) were 43%, 59% and 9% with tofacitinib 5 and 10mg twice daily (BID) and placebo, respectively (each P&lt;0.0001 versus placebo). Tofacitinib 5 and 10mg BID were effective regardless of baseline characteristics. Across subgroups, tofacitinib generally produced greater response rates with the 10 versus 5mg BID dosage. Lower absolute response rates were seen in heavier patients and patients with prior biologic experience.<br />
  
  
  CONCLUSIONS
  Both tofacitinib dosages demonstrated consistent efficacy versus placebo across subgroups. Lower response rates were seen in heavier patients and those with prior biologic experience. Tofacitinib 10mg BID resulted in a substantial proportion of responders regardless of baseline characteristics.<br /><br /><em>J Drugs Dermatol.</em> 2016;15(5):568-580.
authors.forename: M Alan
authors.initials: MA
authors.lastname: Menter
authors.forename: Kim A
authors.initials: KA
authors.lastname: Papp
authors.forename: Jennifer
authors.initials: J
authors.lastname: Cather
authors.forename: Craig
authors.initials: C
authors.lastname: Leonardi
authors.forename: David M
authors.initials: DM
authors.lastname: Pariser
authors.forename: James G
authors.initials: JG
authors.lastname: Krueger
authors.forename: Johannes
authors.initials: J
authors.lastname: Wohlrab
authors.forename: Mario
authors.initials: M
authors.lastname: Amaya-Guerra
authors.forename: Andrzej
authors.initials: A
authors.lastname: Kaszuba
authors.forename: Oleg
authors.initials: O
authors.lastname: Nadashkevich
authors.forename: Tsen-Fang
authors.initials: TF
authors.lastname: Tsai
authors.forename: Pankaj
authors.initials: P
authors.lastname: Gupta
authors.forename: Huaming
authors.initials: H
authors.lastname: Tan
authors.forename: Hernan
authors.initials: H
authors.lastname: Valdez
authors.forename: Lotus
authors.initials: L
authors.lastname: Mallbris
authors.forename: Svitlana
authors.initials: S
authors.lastname: Tatulych
mesh_terms: D000368:Aged; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000008:administration & dosage*; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage*; D011565:Psoriasis / Q000175:diagnosis* / Q000188:drug therapy*; D011743:Pyrimidines / Q000008:administration & dosage*; D011758:Pyrroles / Q000008:administration & dosage*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D010880:Piperidines; D047428:Protein Kinase Inhibitors; D011743:Pyrimidines; D011758:Pyrroles; C479163:tofacitinib