Golimumab, a human antibody to tumour necrosis factor alpha given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Studyopen access
- Authors
- Keystone, Edward C.; Genovese, Mark C.; Klareskog, Lars; Hsia, Elizabeth C.; Hall, Stephen T.; Miranda, Pedro C.; Pazdur, Jacek; Bae, Sang Cheol; Palmer, William; Zrubek, Julie; Wiekowski, Maria T.; Visvanathan, Sudha; Wu, Zhong; Rahman, Mahboob Ur
- Issue Date
- Jun-2009
- Publisher
- BMJ PUBLISHING GROUP
- Citation
- ANNALS OF THE RHEUMATIC DISEASES, v.68, no.6, pp.789 - 796
- Indexed
- SCIE
SCOPUS
- Journal Title
- ANNALS OF THE RHEUMATIC DISEASES
- Volume
- 68
- Number
- 6
- Start Page
- 789
- End Page
- 796
- URI
- https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/176731
- DOI
- 10.1136/ard.2008.099010
- ISSN
- 0003-4967
- Abstract
- Objective: The phase III GO-FORWARD study examined the efficacy and safety of golimumab in patients with active rheumatoid arthritis (RA) despite methotrexate therapy.
Methods: Patients were randomly assigned in a 3 : 3 : 2 : 2 ratio to receive placebo injections plus methotrexate capsules (group 1, n = 133), golimumab 100 mg injections plus placebo capsules (group 2, n = 133), golimumab 50 mg injections plus methotrexate capsules (group 3, n = 89), or golimumab 100 mg injections plus methotrexate capsules (group 4, n = 89). Injections were administered subcutaneously every 4 weeks. The co-primary endpoints were the proportion of patients with 20% or greater 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 methotrexate 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 methotrexate group and 56.2% (p<0.001) in the golimumab 100 mg plus methotrexate 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 (to 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 methotrexate in patients with active RA despite methotrexate therapy significantly reduced the signs and symptoms of RA and improved physical function.
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