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Golimumab, a human antibody to TNF-α given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate: The GO-FORWARD Study
  1. Edward C. Keystone (edkeystone{at}mtsinai.on.ca)
  1. University of Toronto and Mount Sinai Hospital, Canada
    1. Mark C. Genovese (genovese{at}stanford.edu)
    1. Stanford University, United States
      1. Lars Klareskog (lars.klareskog{at}ki.se)
      1. Karolinska Institute and Karolinska University Hospital, Sweden
        1. Elizabeth C. Hsia (ehsia{at}cntus.jnj.com)
        1. Centocor Research and Development, Inc. and University of Pennsylvania School of Medicine, United States
          1. Stephen T. Hall (shall{at}melbournerheumatology.com.au)
          1. Cabrini Medical Centre, Australia
            1. Pedro C. Miranda (mirandac{at}vtr.net)
            1. Universidad de Chile and Hospital San Juan de Dios, Chile
              1. Jacek Pazdur (pazdur{at}ir.ids.pl)
              1. Instytut Reumatologii, Poland
                1. Sang-Cheol Bae (scbae{at}hanyang.ac.kr)
                1. Hanyang University Medical Center, Korea, Republic of
                  1. William Palmer (palms1{at}cox.net)
                  1. Westroads Medical Group, United States
                    1. Julie Zrubek (jzrubek{at}cntus.jnj.com)
                    1. Centocor Research and Development, Inc., United States
                      1. Maria Wiekowski (maria.wiekowski{at}spcorp.com)
                      1. Schering-Plough Research Institute, Inc., United States
                        1. Sudha Visvanathan (svisvana{at}cntus.jnj.com)
                        1. Centocor Research and Development, Inc., United States
                          1. Zhong Wu (zwu7{at}cntus.jnj.com)
                          1. Centocor Research and Development, Inc., United States
                            1. Mahboob U. Rahman (mrahman{at}cntus.jnj.com)
                            1. Centocor Research and Development, Inc. and University of Pennsylvania School of Medicine, United States

                              Abstract

                              Objective: The Phase 3 GO-FORWARD study examined the efficacy and safety of golimumab in patients with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy.

                              Methods: Patients were randomly assigned in a 3:3:2:2 ratio to receive placebo injections plus MTX capsules (Group 1, n=133), golimumab 100 mg injections plus placebo capsules (Group 2, n=133), golimumab 50 mg injections plus MTX capsules (Group 3, n=89), or golimumab 100 mg injections plus MTX capsules (Group 4, n=89). Injections were administered subcutaneously every 4 weeks. The co-primary endpoints were the proportion of patients with ≥20% improvement in the American College of Rheumatology criteria (ACR20) at week 14 and the change from baseline in the Health Assessment Questionnaire-disability index (HAQ-DI) score at week 24.

                              Results: The proportion of patients who achieved an ACR20 response at week 14 was 33.1% in the placebo plus MTX group, 44.4% (p=0.059) in the golimumab 100 mg plus placebo group, 55.1% (p=0.001) in the golimumab 50 mg plus MTX group, and 56.2% (p<0.001) in the golimumab 100 mg plus MTX group. At week 24, median improvements from baseline in HAQ-DI scores were 0.13, 0.13 (p=0.240), 0.38 (p<0.001), and 0.50 (p<0.001), respectively. During the placebo-controlled portion of the study (through week 16), serious adverse events occurred in 2.3%, 3.8%, 5.6%, and 9.0% of patients and serious infections occurred in 0.8%, 0.8%, 2.2%, and 5.6%, respectively.

                              Conclusion: The addition of golimumab to MTX in patients with active RA despite MTX significantly reduced the signs and symptoms of RA and improved physical function.

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