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Clinical Trial
. 2009 Jun;68(6):789-96.
doi: 10.1136/ard.2008.099010. Epub 2008 Dec 9.

Golimumab, a human antibody to tumour necrosis factor {alpha} given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Study

E C Keystone  1 , M C Genovese, L Klareskog, E C Hsia, S T Hall, P C Miranda, J Pazdur, S-C Bae, W Palmer, J Zrubek, M Wiekowski, S Visvanathan, Z Wu, M U Rahman; GO-FORWARD Study
Collaborators, Affiliations
Clinical Trial

Golimumab, a human antibody to tumour necrosis factor {alpha} given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Study

E C Keystone et al. Ann Rheum Dis. 2009 Jun.

Erratum in

  • Ann Rheum Dis. 2011 Jan;70(1):238

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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Conflict of interest statement

Competing interests: Declared. ECK, MCG, LK, STH, PCM, JP, SCB and WP (or their institutions) have received research grants from Centocor and/or Schering-Plough. LK and ECK have received consulting fees from Centocor and/or Schering-Plough. ECH, JZ, SV, ZW and MUR are employees of Centocor Research and Development, Inc and own stock and/or stock options in Johnson&Johnson, Inc. MW is an employee of and owns stock in Schering-Plough Research Institute, Inc.

Figures

Figure 1
Figure 1
Disposition of patients during the study. MTX, methotrexate; SC, subcutaneous.
Figure 2
Figure 2
ACR20, ACR50, ACR70 and ACR90 responses to week 24. Patients who entered early escape at week 16 were considered to be non-responders at all subsequent time points. ACR, American College of Rheumatology; MTX, methotrexate.
See this image and copyright information in PMC

Comment in

References

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