title: Effect of golimumab on patient-reported outcomes in rheumatoid arthritis: results from the GO-FORWARD study.
abstract: OBJECTIVE
  To evaluate the effect of golimumab on physical function, general health, and fatigue in patients with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy.
  
  
  METHODS
  In the multicenter, randomized, placebo-controlled GO-FORWARD study, 444 adults with active RA despite MTX received subcutaneous placebo + MTX (crossover to golimumab 50 mg at Week 24), golimumab 100 mg + placebo, golimumab 50 mg + MTX, or golimumab 100 mg + MTX every 4 weeks. Physical function and general health were assessed using the Health Assessment Questionnaire-Disability Index (HAQ-DI) and Physical and Mental Component Summary (PCS, MCS) scores of the Medical Outcomes Study Short Form-36 questionnaire (SF-36), respectively, through Week 52. Fatigue was measured through Week 24 using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire.
  
  
  RESULTS
  Mean improvements from baseline in HAQ-DI, SF-36 PCS, and FACIT-Fatigue scores (Weeks 14 and 24) were significantly greater for golimumab 50 mg + MTX and 100 mg + MTX versus placebo + MTX. Significantly greater proportions of patients treated with golimumab + MTX achieved clinically meaningful improvements from baseline to Weeks 14 and 24 in HAQ-DI, PCS, and FACIT-Fatigue scores. Mean improvements in SF-36 PCS (Week 14), MCS (Week 24), and FACIT-Fatigue (Weeks 14 and 24) scores were significantly greater for golimumab 100 mg + placebo versus placebo + MTX. Mean improvements from baseline in HAQ-DI, SF-36 PCS, and MCS scores through Week 24 were sustained through Week 52.
  
  
  CONCLUSIONS
  Patients with active RA despite MTX had significant improvement in physical function, general health, and fatigue following golimumab + MTX therapy; improvements in physical function and general health were maintained through Week 52. (Clinical Trials Registration NCT00264550).
authors.affiliation: Stanford University, Palo Alto, CA, USA. genovese@stanford.edu
authors.forename: Mark C
authors.initials: MC
authors.lastname: Genovese
authors.forename: Chenglong
authors.initials: C
authors.lastname: Han
authors.forename: Edward C
authors.initials: EC
authors.lastname: Keystone
authors.forename: Elizabeth C
authors.initials: EC
authors.lastname: Hsia
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Buchanan
authors.forename: Timothy
authors.initials: T
authors.lastname: Gathany
authors.forename: Frederick T
authors.initials: FT
authors.lastname: Murphy
authors.forename: Zhong
authors.initials: Z
authors.lastname: Wu
authors.forename: Shreekant
authors.initials: S
authors.lastname: Parasuraman
authors.forename: Mahboob U
authors.initials: MU
authors.lastname: Rahman
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D018592:Cross-Over Studies; D004359:Drug Therapy, Combination; D005221:Fatigue / Q000150:complications / Q000188:drug therapy / Q000503:physiopathology; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D017060:Patient Satisfaction; D011788:Quality of Life; D020127:Recovery of Function; D057566:Self Report; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; C529000:golimumab; D008727:Methotrexate