Is olokizumab a useful add-on treatment for rheumatoid arthritis?

This study looked at the safety and effectiveness of olokizumab (Artlegia) as an add-on to methotrexate (Otrexup) treatment in rheumatoid arthritis. It found the olokizumab was associated with significant improvements in RA symptoms and physical function.

Rheumatoid arthritis (RA) is a condition affecting the joints, which can cause significant pain and loss of function. RA can be monitored using the American College of Rheumatology 20% response scale (ACR20). The ACR20 measures the symptoms of RA as well as how well the joints are functioning. When these measures improve by 20% or more, this is said to be a significant response to treatment.

One common treatment for RA is methotrexate (MTX). However, many patients still have important symptoms and loss of joint function on MTX treatment. New, targeted therapies such as olokizumab may be beneficial for these patients. Olokizumab is a medication that targets part of the immune system, an inflammatory protein, called IL-6. By blocking this protein, inflammation reduces. It is given by injection under the skin every 2 – 4 weeks. It is not clear if adding olokizumab to standard treatment with MTX improves the treatment response in patients with RA.

428 patients with RA participated in this study. Patients were divided into three groups. Group 1 received olokizumab 64 mg every 2 weeks. Group 2 received olokizumab 64 mg every 4 weeks. Group 3 received a placebo. All patients continued their usual treatment with MTX. Patients' response to treatment was measured using the ACR20 scale.

A significant response to treatment was achieved in 63.6% of group 1, 70.4% of group 2, and 25.9% of group 3. A significant reduction in disease activity after 12 weeks was seen in 33.6% of group 1, 38,7% of group 2 compared to 3.5% of group 3. Disease remission after 24 weeks was reported in 8.4% of group 1, 7.7% of group 2, compared to 0 patients in group 3. Significant improvements in physical function and quality of life were reported in groups 1 and 2 compared to placebo.

Serious complications from treatment were reported in 5.6% of patients on olokizumab and 2.8% of patients on placebo. The most common serious complication was severe infection.

This study showed that olokizumab is a safe and effective add-on treatment for rheumatoid arthritis.  

This study was funded by R-Pharm, the manufacturer of olokizumab. Olokizumab is currently only approved in Russia for the treatment of RA.