Golimumab in rheumatoid arthritis – investigating the safety and efficacy of intravenous administration

This study investigated golimumab (Simponi; GLM) in patients with rheumatoid arthritis (RA) in patients over 65 compared to those under 65. 

They found that intravenous (IV) GLM was effective and well tolerated in these patients.

Rheumatoid arthritis (RA) is caused by chronic inflammation in the joints. RA is treated with disease-modifying anti-rheumatic drugs (DMARDs). Biological DMARDs (bDMARDs) are one type. bDMARDs that block tumor necrosis factor (TNF) are commonly used in RA. TNF is a protein that stimulates immune cells and other inflammatory chemicals. 

Golimumab (GLM) is a TNF blocker. It can be administered subcutaneously (SC, under the skin) or intravenously (IV, into the vein). Studies have shown that SC and IV are similarly effective. The side effect profile is also similar. Most of these studies did not compare results In patients under and over 65. Older patients are at a higher risk of serious infections. It is unclear if IV GLM is safe and effective in patients over 65. 

This study included 592 patients with RA. Patients were randomly assigned to IV GLM or IV placebo. All patients also took 15-25 mg methotrexate (MTX) per week. Treatment lasted up to 112 weeks. Patients in the placebo group were allowed to switch to IV GLM at 24 or 28 weeks. The American College of Rheumatology (ACR) score was used to measure improvement in RA symptoms. ACR20 means a 20% improvement. Side effects were also analyzed. 

At week 24, more patients treated with IV GLM achieved an ACR20 or ACR50. At week 100, the ACR rates were similar in GLM-treated patients under and over 65. The rates of patients stopping IV GLM were higher in patients over 65.

Infections were the most common side effect. There was a higher number of infections in patients over 65 (55.3%) compared to those under 65 (51.6%). Upper respiratory infections were the most common infection. Serious side effects were also more common in the over 65 group (25%) compared to patients under 65 (17.7%).

The authors concluded that IV GLM was similarly effective and well tolerated in patients over 65 and those under 65.

The number of patients over 65 was significantly lower compared to those under 65 (77 out of 592). This may have influenced the results. More studies are needed. This study was funded by Janssen Research & Development, LLC, the manufacturer of golimumab.

If you have any concerns regarding RA management please consult with your physician.