Golimumab (Simponi) increases the chance of remission

This study investigated how safe and successful golimumab is as an add-on therapy to a range of existing rheumatoid arthritis drugs.

Rheumatoid arthritis treatments aim to achieve and maintain remission (a decrease in or disappearance of signs and symptoms of disease). This in turn helps prevent joint damage and disability. The main drugs used for treatment are disease-modifying antirheumatic drugs (DMARDs). The most common DMARD is methotrexate (Rheumatrex, Trexall). However, a range of other DMARDs are also used. These treatments have been successful, but do not work for some patients.

Golimumab, a new drug which is given subcutaneously (an injection into the skin) has been shown to help patients who have not responded to methotrexate. It has not yet been shown if golimumab is also helpful for patients who have not responded to other DMARDs and it is not known if intravenous injection (injection into the veins) of golimumab would improve the chance of remission. 

This was a two part study. Part one included 3,366 patients with active disease despite current DMARD treatment. Patients received monthly injections of golimumab (50 mg into the skin) as well as their current DMARD for 6 months. After 6 months of treatment 82.1% of patients achieved good to moderate response, and 24% had achieved remission. Response rates were not linked to the type of DMARD patients were already receiving.

In the second part of the study 490 patients were included for an additional 6 months of treatment. Of these, 50% continued on monthly injections of golimumab into the skin and 50% were injected directly into the veins. Both strategies were equally as effective; 25% of patients achieved remission in both groups.

In general golimumab was well tolerated. Serious adverse events (any unfavorable and unintended sign, symptom, or disease potentially associated with the use of a medical treatment or procedure) only occurred in 5.7% of patients. Infections occurred in 1.7% of patients and were the most common serious adverse event. 

Add-on golimumab treatment resulted in good/moderate response in most patients. Intravenous injection did not improve the chance of patients responding to treatment.

This study was supported by a grant from Schering-Plough (presently Merck & Co, Whitehouse Station, New Jersey, USA). Merck are also responsible for marketing golimumab.