Golimumab is a human anti-
tumor necrosis factor (TNF)
monoclonal antibody that acts principally by targeting and neutralizing TNF to prevent
inflammation and destruction of cartilage and bone. Large, randomized, double-blind trials in patients with
rheumatoid arthritis who were
methotrexate-naïve (GO-BEFORE) or -experienced (GO-FORWARD) have shown that
golimumab 50 or 100 mg every 4 weeks, in combination with
methotrexate, was more effective than
methotrexate alone for improving signs and symptoms of
arthritis at weeks 14 and/or 24, according to American College of Rheumatology (ACR) criteria. In patients with active
rheumatoid arthritis despite previous treatment with anti-TNF agents (GO-AFTER),
golimumab 50 or 100 mg every 4 weeks was more effective than placebo for improving ACR responses at weeks 14 and 24; most patients in the study received concomitant
methotrexate. In patients with
psoriatic arthritis in the GO-REVEAL study, significantly more
golimumab than placebo recipients achieved a >or=20% improvement in ACR criteria at week 14.
Golimumab was also superior to placebo for improving the signs and symptoms of
ankylosing spondylitis in the GO-RAISE study; significantly more
golimumab than placebo recipients achieved a >or=20% improvement in the Assessment in
Ankylosing Spondylitis (ASAS) criteria at week 14. In the five phase III trials in patients with
rheumatoid arthritis,
psoriatic arthritis, or
ankylosing spondylitis, there was no clear evidence of improved ACR or ASAS responses with the 100 mg dosage compared with the 50 mg dosage of
golimumab. The tolerability profile of
golimumab was generally consistent with that of other anti-TNF agents.