A new article was published J. Clin. Med.:  Population PK/PD Modeling and Simulation to Predict the Comparative Long-Term Efficacy of Olokizumab in Rheumatoid Arthritis Patients

Yuri Kosinsky, Ivan Azarov, Kirill Zhudenkov, Kirill Peskov, Sergey Grishin, Alina Egorova, Yuliya Berezovskaya, Maria Lemak, Mikhail Samsonov and Eugen Feist

This analysis aimed to predict 1-year efficacy of Olokizumab (OKZ) 64 mg administered every two weeks (q2w) and every four weeks (q4w) compared with adalimumab (ADLM) and placebo through virtual clinical trial simulations based on population pharmacokinetic/pharmacodynamic (PK/PD) models. Methods: Nonlinear mixed-effects models were developed using pooled data from phase III studies. Turnover models with a maximum inhibition Imax-type relationship between OKZ concentrations and clinical scores were applied.

The reliability of the simulated extrapolations was validated against published data.

Model predictions showed strong agreement with published long-term data for ADLM and placebo and closely reproduced the actual 1-year response profiles from the OKZ open-label single-arm extension study (OLE).