Tumor necrosis factor (TNF)-alpha is a mediator of articular inflammation in chronic inflammatory diseases. Golimumab is a human monoclonal antibody (mAb) that binds to human TNF-alpha, thus inhibiting its activity. Golimumab was approved on April 24, 2009, for use alone or in combination with methotrexate for the treatment of adult patients with active psoriatic arthritis (PA), for use in combination with methotrexate for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA), and for the treatment of adult patients with active ankylosing spondylitis (AS).

Efficacy. The efficacy of golimumab for the treatment of RA was assessed in 3 multicenter, randomized, double-blind, controlled trials. In Study RA-1, patients who had previously been treated with ≥1 dose of a biologic TNF-blocker without experiencing a serious adverse reaction were randomized to treatment with subcutaneous (SC) golimumab 50 mg, golimumab 100 mg, or placebo; patients were allowed to continue stable doses of concomitant methotrexate, sulfasalazine, and/or hydroxychloroquine. In Study RA-2, patients not previously treated with a biologic TNF-blocker but receiving a stable dose of methotrexate ≥15 mg/wk were randomized to treatment with golimumab 50 mg plus methotrexate, golimumab 100 mg plus methotrexate, golimumab 100 mg alone, or methotrexate alone. The use of other disease-modifying antirheumatic drugs (DMARDs) was prohibited. In Study RA-3, patients who were methotrexate-naïve and had not previously been treated with a biologic TNF-blocker were randomized to golimumab 50 mg plus methotrexate, golimumab 100 mg plus methotrexate, golimumab alone, or methotrexate alone. The use of other DMARDs was prohibited. Across the trials, patients treated with golimumab 50 mg plus methotrexate were more likely to achieve American College of Rheumatology (ACR) 20 response at Week 14 (RA-1, 35%; RA-2, 55%) and Week 24 (RA-1, 34%; RA-2, 60%; RA-3, 62%) compared with patients in the control groups (range at 14 weeks, 18%–33%; range at 24 weeks, 17%–49%). The efficacy of this agent for the treatment of PA was assessed in a multicenter, randomized, double-blind, placebo-controlled trial that randomized patients not previously treated with a biologic TNF-blocker to treatment with golimumab 50 mg, golimumab 100 mg, or placebo. Stable doses of concomitant methotrexate ≤25 mg/wk, low-dose oral corticosteroids, and/or nonsteroidal anti-inflammatory drugs (NSAIDs) were permitted during the trial. Patients treated with golimumab 50 mg plus methotrexate were significantly more likely to achieve an ACR 20 response at Week 14 (51%) versus those treated with placebo (9%). The efficacy of this agent for the treatment of AS was assessed in a multicenter, randomized, double-blind, placebo-controlled trial that randomized patients not previously treated with a biologic TNF-blocker to treatment with golimumab 50 mg, golimumab 100 mg, or placebo. Patients were allowed to continue stable doses of concomitant methotrexate, sulfasalazine, hydroxychloroquine, low-dose corticosteroids, and/or NSAIDs during the trial. Patients treated with golimumab 50 mg were significantly more likely to achieve an Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 14 (59%) compared with patients treated with placebo (22%).

Safety. Patients treated with TNF-blockers have experienced serious and sometimes fatal infections caused by bacterial, mycobacterial, invasive fungal, viral, protozoal, or other opportunistic pathogens. Golimumab treatment should not be initiated in patients with an active infection. Patients should be monitored closely for signs of infection during and after golimumab treatment. Reactivation of tuberculosis and new tuberculosis infections have been reported in patients treated with TNF-blockers. TNF-blocker therapy has also been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic hepatitis B carriers. The risks and benefits of golimumab treatment should be weighed before initiating treatment in a patient with a known malignancy other than a successfully treated nonmelanoma skin cancer or when continuing golimumab treatment in a patient who develops a malignancy. Cases of worsening and new-onset congestive heart failure have been reported in patients treated with TNF-blockers. TNF-blockers have also been associated with exacerbation or new onset of central nervous system (CNS) demyelinating disorders, including multiple sclerosis (MS). The most common adverse events associated with golimumab treatment include upper respiratory tract infection, nasopharyngitis, increased alanine aminotransferase, injection-site erythema, hypertension, and increased aspartate aminotransferase.