title: Efficacy and safety of tofacitinib in US and non-US rheumatoid arthritis patients: pooled analyses of phase II and III.
abstract: OBJECTIVE
  Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. This post-hoc pooled analysis assessed commonalities and differences in tofacitinib efficacy and safety for US versus rest of the world (ROW) populations.
  
  
  METHODS
  Pooled phase (P) III data from patients receiving tofacitinib 5 or 10 mg twice daily (BID) or placebo were assessed for efficacy at Month 3 and for safety outcomes over 12 months. For adverse events of special interest, data on tofacitinib 5 or 10 mg BID or placebo were pooled from six PII and five PIII randomised studies.
  
  
  RESULTS
  PIII data were available for 664 vs. 2447 and PII/PIII data for 943 vs. 3567 US vs. ROW patients, respectively. The US population had a higher proportion of Caucasians (81.5% vs. 54.4%), lower proportion of Asians (1.0% vs. 34.6%), and higher mean body weight (85.7 vs. 66.2 kg) and body mass index (31.5 vs. 25.6 kg/m2) compared with ROW. At Month 3, PIII efficacy was similar between US and ROW as assessed by ACR 20/50/70 response rates, remission rates (DAS 28-4[ESR]<2.6), and HAQ-DI scores. Diarrhoea, peripheral oedema, and upper respiratory tract infection occurred in >5% of PIII patients in the US population. Incidence rates for adverse events of special interest were similar between the US and ROW PII/PIII populations.
  
  
  CONCLUSIONS
  Patients in the US achieved similar efficacy and safety with tofacitinib 5 and 10 mg BID compared with patients in ROW.
authors.affiliation: Metroplex Clinical Research Center, Dallas, TX, USA.
authors.forename: Stanley B
authors.initials: SB
authors.lastname: Cohen
authors.affiliation: Pfizer Inc., Collegeville, PA, USA.
authors.forename: Andrew
authors.initials: A
authors.lastname: Koenig
authors.affiliation: Pfizer Inc., Groton, CT, USA.
authors.forename: Lisy
authors.initials: L
authors.lastname: Wang
authors.affiliation: Pfizer Inc., New York, NY, USA.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Kwok
authors.affiliation: Pfizer Inc., Groton, CT, USA.
authors.forename: Charles A
authors.initials: CA
authors.lastname: Mebus
authors.affiliation: Pfizer Inc., Groton, CT, USA.
authors.forename: Richard  J
authors.initials: R
authors.lastname: Riese
authors.affiliation: Metroplex Clinical Research Center, Dallas, TX, USA. rfleischmann@arthdocs.com.
authors.forename: Roy  M
authors.initials: R
authors.lastname: Fleischmann
mesh_terms: D000284:Administration, Oral; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy* / Q000201:enzymology / Q000276:immunology; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D006801:Humans; D053612:Janus Kinases / Q000037:antagonists & inhibitors / Q000378:metabolism; D061214:Patient Safety; D010880:Piperidines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011743:Pyrimidines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011758:Pyrroles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D016896:Treatment Outcome; D014481:United States
chemical_list: D018501:Antirheumatic Agents; D010880:Piperidines; D047428:Protein Kinase Inhibitors; D011743:Pyrimidines; D011758:Pyrroles; C479163:tofacitinib; D053612:Janus Kinases