Dynamics of inflammatory markers and interleukin 6 levels during olokizumab therapy: Results of a single-center randomized controlled trial

The aim – to evaluate the effect of olokizumab (OKZ) on acute-phase reactants, interleukin (IL) 6, and its soluble receptor (sIL-6R) levels in patients with rheumatoid arthritis (RA) and comorbid depression. Material and methods . A total of 125 patients with RA and comorbid depression were included, including 102 (81.6%) women, with a mean age of 48.5±12.6 years. The majority (86.4%) had high RA activity and had failed stable 12-week therapy with synthetic disease-modifying antirheumatic drugs (DMARDs). Thirty-four (27.2%) patients had failed one or more biological agents. At week 0, all patients were randomized using the sequential numbers method in a 2:2:1 ratio to one of three groups: Group 1 received treatment with sDMARDs + OKZ 64 mg subcutaneously once every 4 weeks (n=49); group 2 – sDMARDs + OKZ 64 mg subcutaneously + psychopharmacotherapy (PPT) (n=51); group 3 – sDMARDs + PFT (n=25). The study duration was 24 weeks. Serum IL-6 concentrations were determined using xMAP multiplex technology on a Bio-Plex Array System analyzer (Bio-Rad, USA) and immunochemiluminescence assay (ICL) on a Cobas e411 analyzer (Roche, Switzerland). Results. The use of OKZ was accompanied by a significant decrease in the level of C-reactive protein (CRP) and calprotectin (CP) in the group as a whole; normalization of the CRP level was noted 4 weeks after the start of therapy (p