Results of a 24-week open-label, non-interventional study on the efficacy and safety of olokizumab therapy in patients with rheumatoid arthritis after switching from anti-B-cell therapy during the SARS-CoV-2 pandemic

Abstract

In the context of the new coronavirus infection (NCI) COVID-19 pandemic, the rheumatological community is facing new challenges in the treatment of immune-inflammatory rheumatic diseases (IIRDs). It has been shown that rheumatological patients have an increased risk of infections and a severe course of NCI and that IIRD therapy also influences the disease outcomes. In particular, the use of the anti-B-cell medication rituximab (RTM) is associated with a higher risk of severe NCI and increased mortality. The COVID-19 pandemic has highlighted the need to find alternative and safe treatment options for these patients. This work is the continuation of a 12-week study on the efficacy and safety of olok-izumab (OKZ) therapy in patients with rheumatoid arthritis (RA) after switching from anti-B-cell therapy during the SARS-CoV-2 pandemic. Objective: to evaluate the efficacy and safety of OKZ (Artlegia®; solution for subcutaneous administration, 160 mg/ml – 0.4 ml) for the treatment of patients with RA in real-life clinical practice after switching from RTM during the COVID-19 pandemic. Material and methods. The study included 19 patients with a confirmed diagnosis of RA who had received RTM at a dose of 500–1000 mg twice every 14 days at least 6 months ago. As disease activity increased, RTM was replaced with OKZ while therapy with synthetic disease-modifying anti-rheumatic drugs (DMARDs) was continued. At weeks 0, 4, 8, 12 and 24 after switching the biologic DMARD, the number of tender (TJN) and swollen (SJN) joints out of 28, pain intensity on a visual analogue scale, ESR, CRP level, disease activity indices CDAI, DAS28-ESR, DAS28-CRP, HAQ index and the safety profile of the therapy were assessed at each visit. Results and discussion. After 4, 8, 12 and 24 weeks of OKZ administration, there was a statistically significant decrease in mean TJN (from 10 to 6.0, 3.0, 5.0 and 4.0, respectively; p < 0.05) and SJN (from 7.0 to 3.0 by week 4 and to 2.0 by weeks 8, 12 and 24; p < 0.05). At the same time, a decrease in CRP and ESR values was also observed: median CRP decreased from 18 to 0.6 mg/l by week 4 and to 0.5 mg/l by weeks 8, 12 and 24 (p < 0.05), ESR from 30 to 5 mm/h in each study period (p < 0.05). CRP levels normalized by week 4, regardless of baseline values. All RA activity indices showed a positive dynamic compared to baseline values from week 4 onwards in each assessment period. After weeks 4, 8, 12 and 24, the median DAS28-ESR decreased from 5.50 to 3.57; 3.30; 3.08 and 3.01 (p < 0.05); DAS28-CRP – from 5.30 to 3.46; 3.23; 3.26 and 3.12 (p < 0.05); CDAI – from 27.0 to 17.0; 12.0; 15.0 and 12.0 (p < 0.05), respectively. All patients showed a decrease in pain by the 4th week of observation. A statistically significant improvement in functional status was observed after the 4th week of therapy and was maintained until week 24. The median HAQ index decreased from 1.62 to 1.50 at weeks 4, 8 and 12 and to 1.12 at week 24 (p < 0.05). Conclusion. The study showed that the non-medical switch from RTM to OKZ during the COVID-19 pandemic was effective and safe.