Evaluating the safety and effect of golimumab (Simponi) injections

This study assessed whether golimumab was effective for treating active rheumatoid arthritis despite methotrexate therapy. The study concluded that 78% of patients achieve good response to long-term golimumab treatment.

Methotrexate is often the first drug used to treat rheumatoid arthritis. However, in many cases methotrexate alone is insufficient to maintain long-term remission of symptoms.

Golimumab is an immune-based treatment (affecting the way the immune system works and preventing immune-related destruction of healthy tissue) administered by subcutaneous injections (injection into the fatty layer under the skin). The long-term benefits and risks of combined golimumab and methotrexate treatment is currently under investigation.

444 patients with active rheumatoid arthritis despite methotrexate treatment participated in this study. Patients were randomized into four different treatment groups: methotrexate plus placebo (Group 1), golimumab 100 mg plus placebo (Group 2), golimumab 50 mg plus methotrexate (Group 3), or golimumab 100 mg plus methotrexate (Group 4). Patients were treated and evaluated for treatment response and safety concerns for over 5 years. Overall, 313 patients were receiving golimumab at week 252 of the study, and 301 patients receiving golimumab throughout the study completed the safety evaluation at week 268 of the study.

By week 24, patients treated with combined golimumab (50mg or 100mg) and methotrexate had greater improvements in rheumatic symptoms, compared to those receiving methotrexate and a placebo. Nearly 50% of patients receiving golimumab plus methotrexate were symptom free at week 104. By the end of the study, 78% of patients receiving combined golimumab plus methotrexate achieved a good or moderate response to treatment, with 36% of patients having no rheumatic symptoms.

Infections were the most common type of adverse-effect among patients receiving golimumab (noted among 172 patients, 39.6%). No increased risk of adverse effects was noted with long-term treatment.

The study concluded that golimumab is safe and effective at relieving rheumatic symptoms and achieving long-term remission.