title: Patient-reported outcomes from a phase III study of baricitinib in patients with conventional synthetic DMARD-refractory rheumatoid arthritis.
abstract: OBJECTIVE
  To evaluate the effect of baricitinib on patient-reported outcomes (PROs) in patients with active rheumatoid arthritis (RA) and an inadequate response or intolerance to conventional synthetic disease-modifying antirheumatic drugs.
  
  
  METHODS
  In this phase III study, patients were randomised 1:1:1 to placebo (N=228), baricitinib 2 mg once daily (QD, N=229) or baricitinib 4 mg QD (N=227). PROs included the Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, measures from patient electronic daily diaries (duration and severity of morning joint stiffness (MJS), Worst Tiredness, Worst Joint Pain), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), SF-36, EuroQol 5-D index scores and visual analogue scales (VAS) and the Work Productivity and Activity Impairment Questionnaire-RA. The primary time point for the study was week 12. Treatment comparisons were assessed with logistic regression for categorical measures and analysis of covariance for continuous variables.
  
  
  RESULTS
  Statistically significant improvements were observed for both baricitinib groups versus placebo in HAQ-DI, PtGA, pain, daily diary measures, EuroQoL index scores and SF-36 physical component score at week 12 and for those measures when assessed at week 24. Baricitinib 2 mg and baricitinib 4 mg were statistically significantly improved versus placebo for the EuroQoL VAS and FACIT-F, respectively, at week 24.
  
  
  CONCLUSIONS
  Baricitinib 2 or 4 mg provided significant improvement versus placebo in PROs across different domains of RA, including physical function, MJS, fatigue, pain and quality of life.
  
  
  BACKGROUND
  NCT01721057; Results.
authors.affiliation: Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds , Leeds , UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Emery
authors.affiliation: Department of Rheumatology , Hospital Universitario Marqués de Valdecilla, IDIVAL , Santander, Cantabria , Spain.
authors.forename: Ricardo
authors.initials: R
authors.lastname: Blanco
authors.affiliation: Buenos Aires University School of Medicine, University of Buenos Aires , Buenos Aires , Argentina.
authors.forename: Jose
authors.initials: J
authors.lastname: Maldonado Cocco
authors.affiliation: Division of Rheumatology, Department of Internal Medicine , Chang Gung Memorial Hospital-Kaohsiung Medical Center, Chang Gung University College of Medicine , Kaohsiung , Taiwan.
authors.forename: Ying-Chou
authors.initials: YC
authors.lastname: Chen
authors.affiliation: Eli Lilly and Company , Indianapolis, Indiana , USA.
authors.forename: Carol L
authors.initials: CL
authors.lastname: Gaich
authors.affiliation: Eli Lilly and Company , Indianapolis, Indiana , USA.
authors.forename: Amy M
authors.initials: AM
authors.lastname: DeLozier
authors.affiliation: Eli Lilly and Company , Indianapolis, Indiana , USA.
authors.forename: Stephanie
authors.initials: S
authors.lastname: de Bono
authors.affiliation: Eli Lilly and Company , Indianapolis, Indiana , USA.
authors.forename: Jiajun
authors.initials: J
authors.lastname: Liu
authors.affiliation: Eli Lilly and Company , Indianapolis, Indiana , USA.
authors.forename: Terence
authors.initials: T
authors.lastname: Rooney
authors.affiliation: Eli Lilly and Company , Indianapolis, Indiana , USA.
authors.forename: Cecile Hsiao-Chun
authors.initials: CH
authors.lastname: Chang
authors.affiliation: Department of Rheumatology , Hôpital Cochin, Assistance Publique, Hôpitaux de Paris, INSERM (U1151), Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, Paris Descartes University , Paris , France.
authors.forename: Maxime
authors.initials: M
authors.lastname: Dougados
keywords: DMARDs (synthetic); Patient perspective; Rheumatoid Arthritis