Centocor, Inc (HORSHAM, Pennsylvania), a wholly owned subsidiary of Johnson & Johnson, announced that 1-year data, presented at the 70th Annual Meeting of the American College of Rheumatology in Washington, DC, showed that nearly 75% of patients with moderately-to-severely active rheumatoid arthritis (RA) receiving golimumab (CNTO 148) and methotrexate experienced at least 20% improvement in arthritis symptoms (ACR 20) at week 52. Investigators also reported that more than one-third of patients treated with golimumab and methotrexate achieved remission at 1 year, as evaluated by Disease Activity Score 28 (DAS28) (DAS < 2.6). The findings are from a randomized, double-blind, placebo-controlled, dose-ranging phase II study. This trial involved 172 patients with active RA for at least 3 months' duration despite methotrexate therapy. Patients were randomized to one of five treatment groups and beginning at week 20, those who were randomized to the placebo group received infliximab (3 mg/kg) at weeks 20, 22, 28, 36, and 44. Patients receiving golimumab continued at their assigned dose (50 or 100 mg) every 4 weeks from week 20 to week 48.

Data from the study showed that significantly more patients in all groups receiving subcutaneous (SC) injections of golimumab plus methotrexate achieved ACR 20, ACR 50, and ACR 70 responses (ie, marked improvement in arthritis symptoms according to the American College of Rheumatology [ACR] scoring criteria) versus patients receiving placebo plus methotrexate through 16 weeks (the primary endpoint of the study). Adults with active RA for at least 3 months' duration despite methotrexate therapy were randomized to one of five treatment groups: placebo every 2 weeks or golimumab 50 or 100 mg every 2 weeks or every 4 weeks. All patients received stable doses of methotrexate of at least 10 mg/week. At week 16, 62%, 31%, and 12% of all patients receiving golimumab (combined golimumab treatment groups) plus methotrexate experienced ACR 20, ACR 50, and ACR 70 improvements, respectively, compared with 37%, 6%, and 0% of patients receiving placebo plus methotrexate, respectively (all P <.05). At week 52 of the study, ACR 20, ACR 50, and ACR 70 scores improved to 74%, 45%, and 22%, respectively, among patients receiving golimumab plus methotrexate (combined golimumab treatment groups). Moreover, patients receiving 50 mg every 2 weeks and 100 mg every 2 weeks maintained efficacy through week 52, even after converting to administration every 4 weeks at week 20.

Patients receiving golimumab plus methotrexate also achieved remission, as assessed by DAS 28, which measures tender and swollen joints, inflammation, and overall disease activity including measurement of serum C-reactive protein (CRP) levels. After 16 weeks of treatment, 27% of patients in the golimumab (combined golimumab treatment groups) plus methotrexate group achieved remission as assessed by DAS28 (DAS <2.6) compared with 6% of patients receiving placebo plus methotrexate (P <.05). Similar remission rates were reported at week 52, with 34% of patients receiving golimumab plus methotrexate achieving remission at that time point.

Golimumab, under development by Centocor and Schering-Plough, is a fully human, anti-TNF-α IgG1 monoclonal antibody that targets and neutralizes both the soluble and the membrane-bound form of TNF-α. Golimumab is being investigated for administration by SC injection and intravenous infusion.

—A. Techman

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