title: Golimumab in patients with active rheumatoid arthritis after treatment with tumor necrosis factor α inhibitors: findings with up to five years of treatment in the multicenter, randomized, double-blind, placebo-controlled, phase 3 GO-AFTER study.
abstract: BACKGROUND
  The aim of this study was to assess long-term golimumab therapy in rheumatoid arthritis (RA) patients who discontinued previous tumor necrosis factor-α (TNF)-inhibitor(s).
  
  
  METHODS
  Patients enrolled into this multicenter, randomized, double-blind, placebo-controlled study of active RA (≥4 tender, ≥4 swollen joints) received placebo (Group 1) or golimumab 50 mg (Group 2) or 100 mg (Group 3) injections every 4 weeks. Patients in Groups 1 and 2 with inadequate response at week 16 escaped to golimumab 50 and 100 mg, respectively. At week 24, Group 1 patients crossed-over to golimumab 50 mg, Group 2 continued golimumab 50/100 mg per escape status, and Group 3 maintained dosing. During the long-term-extension (LTE), golimumab 50 mg could be increased to 100 mg, and 100 mg could be decreased to 50 mg. Data through 5 years are reported for all patients (safety) and patients using methotrexate (efficacy, intention-to-treat (ITT) analysis with last-observation-carried-forward for missing data and non-responder imputation for unsatisfactory efficacy discontinuations).
  
  
  RESULTS
  In total, 459 of 461 randomized patients received the study agent, 304 of whom were methotrexate-treated and included in efficacy analyses. Through week 256, the proportions of methotrexate-treated patients achieving American-College-of-Rheumatology (ACR) responses were 37.6% to 47.0% for ACR20, 21.4% to 35.0% for ACR50, and 7.8% to 17.0% for ACR70 response across randomized groups. Golimumab safety through week 268 was generally consistent with that at week 24 and week 160 and other anti-TNF agents.
  
  
  CONCLUSIONS
  In some patients with active RA discontinuing previous TNF-antagonist therapy, golimumab safety and efficacy, assessed conservatively with ITT analyses, was confirmed through 5 years.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT00299546 . Registered 03 March 2006.
authors: Department of Medicine, Medical University of Vienna, Hietzing Hospital, Vienna, Austria. josef.smolen@wienkav.at.|Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Waehringer Guertel 18-20, Vienna, 1090, Austria. josef.smolen@wienkav.at.|Department of Medicine III, Hietzing Hospital, Waehringer Guertel 18-20, Vienna, A-1090, Austria. josef.smolen@wienkav.at.
authors: Josef S
authors: JS
authors: Smolen
authors: University of Massachusetts Medical School and UMass Memorial Center, Rheumatology Center, Memorial Campus, 119 Belmont Street, Worcester, MA, 01605, USA. jonathan.kay@umassmemorial.org.
authors: Jonathan
authors: J
authors: Kay
authors: Translational Medicine Group, Alexion Pharmaceuticals, 75 Sidney Street, Cambridge, MA, 02139, USA. mittiekdoyle@hotmail.com.
authors: Mittie
authors: M
authors: Doyle
authors: Academic Medical Center/University of Amsterdam & Atrium Medical Center Heerlen, Henri Dunantstraat 5, Heerlen, PC, 6419, The Netherlands. landewe@rlandewe.nl.
authors: Robert
authors: R
authors: Landewé
authors: Divisions of Rheumatology and Epidemiology, Mayo Clinic College of Medicine, 200 1st St. S.W., Rochester, MN, 55905, USA. matteson.eric@mayo.edu.
authors: Eric L
authors: EL
authors: Matteson
authors: Arthritis & Rheumatic Disease Specialties, 21097 NE 27th Court, Suite 200, Aventura, FL, 33180, USA. ngaylis@aol.com.
authors: Norman
authors: N
authors: Gaylis
authors: Schoen Klinik Hamburg Eilbek, Dehnhaide 120, Hamburg, 22081, Germany. j.wollenhaupt@t-online.de.
authors: Jürgen
authors: J
authors: Wollenhaupt
authors: Altoona Center of Clinical Research, 175 Meadowbrook Lane, PO Box 1018, Duncansville, PA, 16635, USA. ftmurphy8@gmail.com.|Division of Rheumatology, University of Pennsylvania Medical School and Hospital of the University of Pennsylvania, Perelman Center 1 South, 3400 Civic Center Blvd., Philadelphia, PA, 19104, USA. ftmurphy8@gmail.com.
authors: Frederick T
authors: FT
authors: Murphy
authors: Janssen Research & Development, LLC, 1400 McKean Road, PO Box 776, Spring House, PA, 19477, USA. sxu2@its.jnj.com.
authors: Stephen
authors: S
authors: Xu
authors: Janssen Research & Development, LLC, 1400 McKean Road, PO Box 776, Spring House, PA, 19477, USA. yzhou45@its.jnj.com.
authors: Yiying
authors: Y
authors: Zhou
authors: Division of Rheumatology, University of Pennsylvania Medical School and Hospital of the University of Pennsylvania, Perelman Center 1 South, 3400 Civic Center Blvd., Philadelphia, PA, 19104, USA. ehsia@its.jnj.com.|Janssen Research & Development, LLC, 1400 McKean Road, PO Box 776, Spring House, PA, 19477, USA. ehsia@its.jnj.com.
authors: Elizabeth C
authors: EC
authors: Hsia
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004311:Double-Blind Method; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D000911:Antibodies, Monoclonal; D007155:Immunologic Factors; D014409:Tumor Necrosis Factor-alpha; C529000:golimumab
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