1. Olokizumab was shown to be superior to placebo in improving symptoms of rheumatoid arthritis (RA).
2. Olokizumab was also non-inferior to adalimumab in improving rheumatoid arthritis symptoms.
Level of evidence assessment: 1 (Excellent)
Summary of the study: Rheumatoid arthritis is an inflammatory autoimmune disease characterized by persistent synovitis and destructive changes in the bones and cartilage of several joints, leading to joint damage and permanent disability. Previous studies have shown that the combination of adalimumab and methotrexate is superior to monotherapy in the treatment of rheumatoid arthritis in achieving remission or reducing disease activity. It has also been proposed that interleukin-6 receptor blockers, such as olokizumab, could potentially be used to treat RA. The cytokine IL-6 has multiple functions in cell growth, bone metabolism and inflammation. However, there is a lack of knowledge regarding the understanding of the efficacy and safety of subcutaneous olokizumab in the treatment of RA. Overall, this study found that treatment with olokizumab plus methotrexate resulted in a higher percentage of patients with a significant response to RA symptoms compared to placebo plus methotrexate. He also found that it was not inferior to treatment with adalimumab plus methotrexate. This study was limited by a relatively small number of patients over a short period, in particular for the evaluation of rare events such as cancers. Additionally, a lack of imaging assessment was performed on joint disease. Nevertheless, the results of this study are significant, as they demonstrate that treatment with olokizumab plus methotrexate provides clinical benefit for the management of RA symptoms compared to placebo and treatment with adalimumab.
Click to read the study in the NEJM
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In depth [randomized control trial]: This phase three, multicenter, double-blind, randomized controlled trial was conducted at 209 sites in the United States, Europe, Asia and Latin America. Patients 18 years of age or older with active rheumatoid arthritis, who had an inadequate response to methotrexate for at least 12 weeks, who had at least six swollen joints, at least six painful joints and an elevated CRP level were eligible for the ‘study. Patients were randomized to receive either olokizumab, adalimumab, or placebo. All patients continued to receive methotrexate. The primary endpoint measured was an improvement of at least 20% in American College of Rheumatology (ACR) response criteria. An ACR20 response was defined as a decrease of 20% or more in the number of tender joints and the number of swollen joints, as well as an improvement of 20% or more in at least three of the five measures. The measures included factors such as the patient’s assessment of pain, the patient’s function, the physician’s assessment of disease activity, and the level of acute phase reactants. Based on the primary analysis, an ACR20 response at week 12 occurred in 44.4% of patients receiving placebo, in 70.3% of patients receiving olokizumab every other week (difference vs placebo, 25 .9%, 97.5% confidence interval [CI], 17.1 to 34.1), in 71.4% receiving olokizumab every four weeks (difference vs. placebo, 27.0%; 97.5% CI, 18.3 to 35.2) and in 66.9% receiving adalimumab (difference vs. placebo, 22.5%; 95% CI, 14.8 to 29.8) (p
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