title: Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON).
abstract: OBJECTIVE
  To assess baricitinib on patient-reported outcomes (PROs) in patients with moderately to severely active rheumatoid arthritis, who had insufficient response or intolerance to ≥1 tumour necrosis factor inhibitors (TNFis) or other biological disease-modifying antirheumatic drugs (bDMARDs).
  
  
  METHODS
  In this double-blind phase III study, patients were randomised to once-daily placebo or baricitinib 2 or 4 mg for 24 weeks. PROs included the Short Form-36, EuroQol 5-D, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, duration of morning joint stiffness (MJS) and Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis. Treatment comparisons were performed with logistic regression for categorical measures or analysis of covariance for continuous variables.
  
  
  RESULTS
  527 patients were randomised (placebo, 176; baricitinib 2 mg, 174; baricitinib 4 mg, 177). Both baricitinib-treated groups showed statistically significant improvements versus placebo in most PROs. Improvements were generally more rapid and of greater magnitude for patients receiving baricitinib 4 mg than 2 mg and were maintained to week 24. At week 24, more baricitinib-treated patients versus placebo-treated patients reported normal physical functioning (HAQ-DI <0.5; p≤0.001), reductions in fatigue (FACIT-F ≥3.56; p≤0.05), improvements in PtGA (p≤0.001) and pain (p≤0.001) and reductions in duration of MJS (p<0.01).
  
  
  CONCLUSIONS
  Baricitinib improved most PROs through 24 weeks compared with placebo in this study of treatment-refractory patients with previously inadequate responses to bDMARDs, including at least one TNFi. PRO results aligned with clinical efficacy data for baricitinib.
  
  
  BACKGROUND
  NCT01721044; Results.
authors: Medical University of Vienna and Hietzing Hospital, Vienna, Austria.
authors: Josef S
authors: http://orcid.org/0000-0002-8899-9087
authors: JS
authors: Smolen
authors: Albany Medical College, Albany, New York, USA.
authors: Joel M
authors: JM
authors: Kremer
authors: Eli Lilly and Company, Indianapolis, Indiana, USA.
authors: Carol L
authors: CL
authors: Gaich
authors: Eli Lilly and Company, Indianapolis, Indiana, USA.
authors: Amy M
authors: AM
authors: DeLozier
authors: Eli Lilly and Company, Indianapolis, Indiana, USA.
authors: Douglas E
authors: DE
authors: Schlichting
authors: Eli Lilly and Company, Indianapolis, Indiana, USA.
authors: Li
authors: L
authors: Xie
authors: Eli Lilly and Company, Indianapolis, Indiana, USA.
authors: Ivaylo
authors: I
authors: Stoykov
authors: Eli Lilly and Company, Indianapolis, Indiana, USA.
authors: Terence
authors: T
authors: Rooney
authors: University of New South Wales, Sydney, New South Wales, Australia.
authors: Paul
authors: P
authors: Bird
authors: Divisions of Rheumatology, Ophthalmology and Immunology, Valme University Hospital, Sevilla, Spain.
authors: Juan Miguel
authors: JM
authors: Sánchez Bursón
authors: Stanford University Medical Center, Palo Alto, California, USA.
authors: Mark C
authors: MC
authors: Genovese
authors: Lapeyronie Hospital, Montpellier University, Montpellier, France.
authors: Bernard
authors: B
authors: Combe
mesh_terms: D000328:Adult; D001172:Arthritis, Rheumatoid / Q000150:complications / Q000188:drug therapy*; D001384:Azetidines / Q000627:therapeutic use*; D004311:Double-Blind Method; D004526:Efficiency; D006801:Humans; D010147:Pain Measurement; D000071066:Patient Reported Outcome Measures; D000069597:Presenteeism; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use*; D011687:Purines; D011720:Pyrazoles; D011788:Quality of Life; D012720:Severity of Illness Index; D013449:Sulfonamides / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D055815:Young Adult
chemical_list: D001384:Azetidines; D047428:Protein Kinase Inhibitors; D011687:Purines; D011720:Pyrazoles; D013449:Sulfonamides; C000596027:baricitinib
keywords: DMARDs (biologic); DMARDs (synthetic); Outcomes research; Patient perspective; Rheumatoid Arthritis