title: Maintenance of Clinical and Radiographic Benefit With Intravenous Golimumab Therapy in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy: Week-112 Efficacy and Safety Results of the Open-Label Long-Term Extension of a Phase III, Double-Blind, Randomized, Placebo-Controlled Trial.
abstract: OBJECTIVE
  To evaluate the safety, efficacy, pharmacokinetics, immunogenicity, and radiographic progression through 2 years of treatment with intravenous (IV) golimumab plus methotrexate (MTX) in an open-label extension of a phase III trial of patients with active rheumatoid arthritis (RA) despite MTX therapy.
  
  
  METHODS
  In the phase III, double-blind, randomized, placebo-controlled GO-FURTHER trial, 592 patients with active RA were randomized (2:1) to intravenous golimumab 2 mg/kg plus MTX (Group 1) or placebo plus MTX (Group 2) at weeks 0 and 4, then every 8 weeks thereafter; placebo patients crossed over to golimumab at week 16 (early escape) or week 24 (crossover). The final golimumab infusion was at week 100. Assessments included American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) response criteria, 28-joint count disease activity score using the C-reactive protein level (DAS28-CRP), physical function and quality of life measures, and changes in the modified Sharp/van der Heijde scores (SHS). Safety was monitored through week 112.
  
  
  RESULTS
  In total, 486 patients (82.1%) continued treatment through week 100, and 68.1%, 43.8%, and 23.5% had an ACR20/50/70 response, respectively, at week 100. Clinical response and improvements in physical function and quality of life were generally maintained from week 24 through 2 years. Mean change from baseline to week 100 in SHS score was 0.74 in Group 1 and 2.10 in Group 2 (P = 0.005); progression from week 52 to week 100 was clinically insignificant in both groups. A total of 481 patients completed the safety followup through week 112; 79.1% had an adverse event, and 18.2% had a serious adverse event.
  
  
  CONCLUSIONS
  Clinical response to IV golimumab plus MTX was maintained through week 100. Radiographic progression following golimumab treatment was clinically insignificant between week 52 and week 100. No unexpected adverse events occurred through week 112, and the safety profile was consistent with anti-tumor necrosis factor therapy.
authors.affiliation: Johns Hopkins University, Baltimore, Maryland.
authors.forename: Clifton O
authors.initials: CO
authors.lastname: Bingham
authors.affiliation: Janssen Research and Development, Spring House, Pennsylvania.
authors.forename: Alan M
authors.initials: AM
authors.lastname: Mendelsohn
authors.affiliation: Janssen Research and Development, Spring House, Pennsylvania.
authors.forename: Lilianne
authors.initials: L
authors.lastname: Kim
authors.affiliation: Janssen Research and Development, Spring House, Pennsylvania.
authors.forename: Zhenhua
authors.initials: Z
authors.lastname: Xu
authors.affiliation: Janssen Research and Development, Spring House, Pennsylvania.
authors.forename: Jocelyn
authors.initials: J
authors.lastname: Leu
authors.affiliation: Janssen Global Service, Malvern, Pennsylvania.
authors.forename: Chenglong
authors.initials: C
authors.lastname: Han
authors.affiliation: Janssen Research and Development, Spring House, Pennsylvania.
authors.forename: Kim Hung
authors.initials: KH
authors.lastname: Lo
authors.affiliation: UZ KU, Leuven, Belgium.
authors.forename: Rene
authors.initials: R
authors.lastname: Westhovens
authors.affiliation: Brigham and Women's Hospital, Boston, Massachusetts.
authors.forename: Michael E
authors.initials: ME
authors.lastname: Weinblatt
mesh_terms: D061605:Administration, Intravenous; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D001172:Arthritis, Rheumatoid / Q000097:blood / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000503:physiopathology; D015415:Biomarkers / Q000097:blood; D001799:Blood Sedimentation; D002097:C-Reactive Protein / Q000378:metabolism; D018592:Cross-Over Studies; D004185:Disability Evaluation; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D006801:Humans; D018836:Inflammation Mediators / Q000097:blood; D008727:Methotrexate / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D011788:Quality of Life; D011859:Radiography; D020127:Recovery of Function; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D015415:Biomarkers; D018836:Inflammation Mediators; D002097:C-Reactive Protein; C529000:golimumab; D008727:Methotrexate