Olokizumab, a monoclonal antibody against interleukin 6, in combination with methotrexate in patients with rheumatoid arthritis inadequately controlled by methotrexate: Efficacy and safety results of a randomised controlled phase III study
Annals of Rheumatic Diseases Aug 06, 2021
Nasonov E, Fatenejad S, Feist E, et al. - The findings revealed that without discernible differences between the two regimens, treatment with olokizumab (OKZ) was correlated with significant improvement in signs, symptoms, and physical function of rheumatoid arthritis. As per the findings, safety was as expected for this class of agents.
The study found low immunogenicity.
Researchers recruited a total of 428 patients.
Compared with placebo (25.9%), ACR20 responses were more frequent with OKZ every 2 weeks (63.6%) and OKZ every 4 weeks (70.4%).
Significant differences were observed in all secondary efficacy endpoints between OKZ-treated arms and placebo.
Treatment-emergent serious adverse events (TESAEs) were reported by more patients in the OKZ groups compared with placebo.
Infections were the most common TESAEs. No subjects developed neutralizing anti-drug antibodies.
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