title: Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: Long-term efficacy and safety results from 2 randomized phase-III studies and 1 open-label long-term extension study.
abstract: BACKGROUND
  Tofacitinib is an oral Janus kinase inhibitor being investigated for psoriasis.
  
  
  OBJECTIVE
  We sought to report longer-term tofacitinib efficacy and safety in patients with moderate to severe psoriasis.
  
  
  METHODS
  Data from 2 identical phase-III studies, Oral-treatment Psoriasis Trial Pivotal 1 and 2, were pooled with data from these patients in an ongoing open-label long-term extension study. Patients (n = 1861) were randomized 2:2:1 to tofacitinib 5 mg, 10 mg, or placebo twice daily (BID). At week 16, placebo patients were rerandomized to tofacitinib. Pivotal study participants could enroll into the long-term extension where they received tofacitinib at 10 mg BID for 3 months, after which dosing could be 5 or 10 mg BID.
  
  
  RESULTS
  At week 28, the proportions of patients randomized to tofacitinib 5 and 10 mg BID achieving 75% or greater reduction in Psoriasis Area and Severity Index score from baseline were 55.6% and 68.8%, and achieving Physician Global Assessment of clear or almost clear were 54.7% and 65.9%. Efficacy was maintained in most patients through 24 months. Serious adverse events and discontinuations because of adverse events were reported in less than 11% of patients over 33 months of tofacitinib exposure.
  
  
  CONCLUSIONS
  There was no dose comparison beyond week 52.
  
  
  CONCLUSIONS
  Oral tofacitinib demonstrated sustained efficacy in patients with psoriasis through 2 years, with 10 mg BID providing greater efficacy than 5 mg BID. No unexpected safety findings were observed.
authors.affiliation: Probity Medical Research and K. Papp Clinical Research Inc, Waterloo, Ontario, Canada.
authors.forename: Kim A
authors.initials: KA
authors.lastname: Papp
authors.affiliation: Rockefeller University, New York, New York.
authors.forename: James G
authors.initials: JG
authors.lastname: Krueger
authors.affiliation: Wake Forest Baptist Health, Winston-Salem, North Carolina.
authors.forename: Steven R
authors.initials: SR
authors.lastname: Feldman
authors.affiliation: Dalhousie University, Halifax, Nova Scotia, Canada.
authors.forename: Richard G
authors.initials: RG
authors.lastname: Langley
authors.affiliation: Comprehensive Center for Inflammation Research, University Hospital Schleswig-Holstein Campus Lübeck, Lübeck, Germany.
authors.forename: Diamant
authors.initials: D
authors.lastname: Thaci
authors.affiliation: Division of Dermatology, Tokyo Yamate Medical Center, Tokyo, Japan.
authors.forename: Hideshi
authors.initials: H
authors.lastname: Torii
authors.affiliation: Department of Dermatology, University of Texas Medical School, Houston, Texas.
authors.forename: Stephen
authors.initials: S
authors.lastname: Tyring
authors.affiliation: Pfizer Inc, Groton, Connecticut.
authors.forename: Robert
authors.initials: R
authors.lastname: Wolk
authors.affiliation: Pfizer Inc, Cambridge, Massachusetts.
authors.forename: Annie
authors.initials: A
authors.lastname: Gardner
authors.affiliation: Pfizer Inc, Groton, Connecticut.
authors.forename: Charles
authors.initials: C
authors.lastname: Mebus
authors.affiliation: Pfizer Inc, Groton, Connecticut.
authors.forename: Huaming
authors.initials: H
authors.lastname: Tan
authors.affiliation: Pfizer Inc, Groton, Connecticut.
authors.forename: Yingchun
authors.initials: Y
authors.lastname: Luo
authors.affiliation: Pfizer Inc, Groton, Connecticut.
authors.forename: Pankaj
authors.initials: P
authors.lastname: Gupta
authors.affiliation: Dermatology Unit, Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.
authors.forename: Lotus
authors.initials: L
authors.lastname: Mallbris
authors.affiliation: Pfizer Inc, Groton, Connecticut. Electronic address: svitlana.tatulych@pfizer.com.
authors.forename: Svitlana
authors.initials: S
authors.lastname: Tatulych
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D002908:Chronic Disease; D017326:Clinical Trials, Phase III as Topic; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053612:Janus Kinases / Q000008:administration & dosage / Q000037:antagonists & inhibitors*; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; 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*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D010880:Piperidines; D047428:Protein Kinase Inhibitors; D011743:Pyrimidines; D011758:Pyrroles; C479163:tofacitinib; D053612:Janus Kinases
keywords: Janus kinase inhibitor; efficacy; long-term; psoriasis; randomized controlled trial; safety; tofacitinib