RESEARCH - Simponi in patients with active RA despite MTX: GO-FORWARD

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Ann Rheum Dis. 2010 May 5. [Epub ahead of print]

Golimumab in patients with active rheumatoid arthritis despite

methotrexate therapy: 52-week results of the GO-FORWARD study.

Keystone E, Genovese MC, Klareskog L, Hsia EC, Hall S, Miranda PC,

Pazdur J, Bae SC, Palmer W, Xu S, Rahman MU.

1University of Toronto and Mount Sinai Hospital, Toronto, Ontario, Canada.

Abstract

OBJECTIVE: To evaluate the efficacy and safety of golimumab to 52

weeks in patients with active rheumatoid arthritis despite

methotrexate.

METHODS: Patients were randomly assigned to receive placebo plus

methotrexate (group 1), golimumab 100 mg plus placebo (group 2),

golimumab 50 mg plus methotrexate (group 3) and golimumab 100 mg plus

methotrexate (group 4). At week 16, patients in groups 1, 2 and 3 who

had less than 20% improvement in tender and swollen joints entered

early escape. At week 24, patients in group 1 who had not entered

early escape crossed over to 50 mg golimumab plus methotrexate.

RESULTS: At week 16, 31%, 27% and 17% of patients in groups 1, 2 and

3, respectively, entered early escape. At week 52, 44%, 45%, 64% and

58% of patients in groups 1, 2, 3 and 4, respectively, achieved 20%

improvement in the American College of Rheumatology criteria; and 34%,

31%, 42% and 53%, respectively, achieved low disease activity (</=3.2)

according to the 28-joint disease activity score. Patients in group 4

appeared to have an increased risk of serious adverse events and

serious infections.

CONCLUSION: The results of various outcome measures showed that the

response rates achieved by patients receiving golimumab to 24 weeks

were sustained to 52 weeks. The safety profile appeared to be

consistent with the known safety profile of tumour necrosis factor

inhibitors.

PMID: 20444749

http://www.ncbi.nlm.nih.gov/pubmed/20444749

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