title: Early clinical response to tofacitinib treatment as a predictor of subsequent efficacy: Results from two phase 3 studies of patients with moderate-to-severe plaque psoriasis.
abstract: The ability to predict response to psoriasis treatments has important implications. Tofacitinib is an oral JAK inhibitor being investigated for psoriasis.
  
  
  
  The objective of this study is to identify and validate the clinical predictors of responses in psoriasis patients treated with tofacitinib.
  
  
  
  Selected baseline characteristics or early improvement in Psoriasis Area and Severity Index (PASI) in the phase 3 tofacitinib study OPT 1 (NCT01276639) were evaluated as predictors for a clinical response (75% improvement in PASI [PASI75]) at week 16. Predictive ability was assessed by the area-under-the-receiver operating characteristic curve (AUC-ROC). The predictive ability of the identified variables was validated with study OPT 2 (NCT01309737).
  
  
  
  PASI improvement at weeks 8 and 12 demonstrated good discriminatory abilities to predict PASI75 response at week 16 (AUC-ROC ≥86% and 94%, respectively) in OPT 1. Validation with PASI50 response at week 8 in OPT 2 to predict PASI75 response at week 16 showed that the sensitivity, specificity, PPV, and NPV were 88%, 69%, 80%, and 81%, respectively, in tofacitinib-treated subjects.
  
  
  
  Achieving a PASI50 response after 8 weeks of treatment with tofacitinib in psoriasis patients appears to be a reliable predictor of achieving a PASI75 response at week 16.
  
  
  
  clinicaltrials.gov: NCT01276639 and NCT01309737.
authors.affiliation: a Global Medicines Development, Global Innovative Pharma, Pfizer Inc , Groton , CT , USA.
authors.forename: Huaming
authors.initials: H
authors.lastname: Tan
authors.affiliation: b Global Medical Affairs, Global Innovative Pharma, Pfizer Inc. , New York , NY , USA.
authors.forename: Hernan
authors.initials: H
authors.lastname: Valdez
authors.affiliation: c The Dermatology Centre , Salford Royal NHS Foundation Trust, The University of Manchester, Manchester Academic Health Science Centre , Manchester , UK.
authors.forename: Chris E M
authors.initials: CE
authors.lastname: Griffins
authors.affiliation: d Psoriasis-Center at the Department of Dermatology , University Medical Center Schleswig-Holstein , Campus Kiel , Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Mrowietz
authors.affiliation: b Global Medical Affairs, Global Innovative Pharma, Pfizer Inc. , New York , NY , USA.
authors.forename: Anna
authors.initials: A
authors.lastname: Tallman
authors.affiliation: a Global Medicines Development, Global Innovative Pharma, Pfizer Inc , Groton , CT , USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Wolk
authors.affiliation: e Department of Dermatology, Feinberg School of Medicine , Northwestern University , Chicago , IL , USA.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Gordon
mesh_terms: D000284:Administration, Oral; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000627:therapeutic use*; D011565:Psoriasis / Q000188:drug therapy*; D011743:Pyrimidines / Q000627:therapeutic use*; D011758:Pyrroles / Q000627:therapeutic use*; D012372:ROC Curve; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D010880:Piperidines; D011743:Pyrimidines; D011758:Pyrroles; C479163:tofacitinib
keywords: AUC; PASI50; PASI75; early clinical improvement; predictor of efficacy