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.
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Funding This study was funded by Centocor Research and Development, Inc, a wholly owned subsidiary of Johnson & Johnson, Inc and Schering Plough Research Institute, Inc.
Competing interests EK, MCG, LK, SH, PCM, JP, S-CB and WP (or their institutions) have received research grants from Centocor and/or Schering-Plough. LK and EK have received consulting fees from Centocor and/or Schering-Plough. ECH, MUR and SX are employees of Centocor Research and Development, Inc and own stock and/or stock options in Johnson & Johnson, Inc.
Ethics approval This study protocol was conducted with the approval of the ethics committee at each study site.
Patient consent Obtained.
Provenance and peer review Not commissioned; externally peer reviewed.