title: Tofacitinib or adalimumab versus placebo: patient-reported outcomes from a phase 3 study of active rheumatoid arthritis.
abstract: To evaluate effects of tofacitinib or adalimumab on patient-reported outcomes (PROs) in patients with moderate to severe RA and inadequate responses to MTX.
  
  
  
  In this 12-month, phase 3, randomized controlled trial (ORAL Standard), patients (n = 717) receiving background MTX were randomized to tofacitinib 5 or 10 mg twice daily (BID), adalimumab 40 mg once every 2 weeks or placebo. PROs included HAQ-Disability Index, Patient Global Assessment of Arthritis, Patient Assessment of Arthritis Pain, health-related quality of life (Short Form-36 [SF-36]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) and sleep (Medical Outcomes Study-Sleep).
  
  
  
  At month 3, tofacitinib 10 mg BID treatment resulted in significant changes from baseline vs placebo across all PROs, sustained to month 12, with the highest number of patients reporting improvements ⩾minimum clinically important differences vs placebo (P < 0.05). Changes from baseline at month 3 with tofacitinib 5 mg BID and adalimumab were similar and statistically significant vs placebo across most PROs, excluding SF-36 Mental Component Score and Social Functioning, Role Emotional, and Mental Health domains, with significantly more patients reporting improvements ⩾minimum clinically important differences. Numbers Needed to Treat were lowest for tofacitinib 10 mg BID and similar between tofacitinib 5 mg BID and adalimumab.
  
  
  
  Patients with moderate to severe RA and inadequate responses to MTX reported improvements across a broad range of PROs with tofacitinib 5 and 10 mg BID and adalimumab that were significantly superior to placebo.
authors.affiliation: Private residence, CA, USA.
authors.forename: Vibeke
authors.initials: V
authors.lastname: Strand
authors.affiliation: Department of Medicine, Karolinska Institute, Stockholm, Sweden.
authors.forename: Ronald F
authors.initials: RF
authors.lastname: van Vollenhoven
authors.affiliation: Department of Internal Medicine, Seoul National University, Seoul, Republic of Korea.
authors.forename: Eun Bong
authors.initials: EB
authors.lastname: Lee
authors.affiliation: Rheumatology Department, Metroplex Clinical Research Center, Dallas, TX.
authors.forename: Roy
authors.initials: R
authors.lastname: Fleischmann
authors.affiliation: Medicines Development Group, Pfizer Inc, Groton, CT and.
authors.forename: Samuel H
authors.initials: SH
authors.lastname: Zwillich
authors.affiliation: Medicines Development Group, Pfizer Inc, Groton, CT and.
authors.forename: David
authors.initials: D
authors.lastname: Gruben
authors.affiliation: Medicines Development Group, Pfizer Inc, New York, NY, USA.
authors.forename: Tamas
authors.initials: T
authors.lastname: Koncz
authors.affiliation: Medicines Development Group, Pfizer Inc, Groton, CT and.
authors.forename: Bethanie
authors.initials: B
authors.lastname: Wilkinson
authors.affiliation: Medicines Development Group, Pfizer Inc, Groton, CT and gene.wallenstein@pfizer.com.
authors.forename: Gene
authors.initials: G
authors.lastname: Wallenstein
mesh_terms: D000068879:Adalimumab / Q000008:administration & dosage*; D000328:Adult; D018501:Antirheumatic Agents / Q000008:administration & dosage*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D010880:Piperidines / Q000008:administration & dosage*; D011743:Pyrimidines / Q000008:administration & dosage*; D011758:Pyrroles / Q000008:administration & dosage*; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D010880:Piperidines; D011743:Pyrimidines; D011758:Pyrroles; C479163:tofacitinib; D000068879:Adalimumab; D008727:Methotrexate
keywords: Janus kinase; patient-reported outcomes; phase 3; rheumatoid arthritis; tofacitinib