Direct interleukin-6 blockade in real-world clinical practice – a path to rationalization of pharmacotherapy and control of rheumatoid arthritis

Interleukin (IL)-6 is a key mediator in the pathogenesis of rheumatoid arthritis (RA). Olokizumab (OKZ, Artlegia®, R-Pharm) is a direct IL-6 inhibitor whose efficacy has been demonstrated in randomized controlled trials, post-marketing studies, and real-world practice. However, different dosing regimens of OKZ and their impact on its usage frequency, as well as on doses of glucocorticoids (GCs) and nonsteroidal anti-inflammatory drugs (NSAIDs), have been insufficiently studied. Objective: to evaluate the efficacy and safety of OKZ in routine clinical practice, with emphasis on the use of different dosing regimens and concomitant use of GCs and NSAIDs in patients with RA. Material and methods. In a multicenter retrospective observational program included patients in whom OKZ therapy was initiated in real-world clinical practice from 01.12.2023 to 30.11.2024 with subsequent 12-month follow-up. A total of 1240 adult patients with active RA meeting the 2010 ACR/EULAR criteria were enrolled. Of these, 80.5% were women; median age was 55 years; median RA duration was 87 months; 86.5% of patients were rheumatoid factor positive, 82.7% were positive for anti-cyclic citrullinated peptide antibodies; a high comorbidity burden was noted. Patients with incomplete DAS28-CRP/CDAI data or follow-up <3 months were excluded from the efficacy analysis. Assessments were performed at baseline and at 3, 6, and 12 months. Results and discussion. At baseline, 89.4% of patients had high/moderate RA activity according to DAS28-CRP. OKZ was prescribed once every 4 weeks in 89.8% of cases; in patients with higher laboratory activity, once every 2 weeks in 10.2% (p<0.01). A marked positive response with achievement of remission/low disease activity according to DAS28-CRP by month 12 was observed in 78.4% of cases. The proportion of patients receiving GCs decreased from 51.3% to 15.7%; median daily GCs dose decreased from 7.5 to 5.0 mg (p<0.05); the proportion of patients continuously using NSAIDs decreased from 32.8% to 1.9%. Adverse events (AEs) were reported in 9.0% of patients (OKZ was discontinued in 4.5%); no new AEs were identified. Conclusion. In the vast majority of cases, OKZ is used at a dose of 64 mg once every 4 weeks, providing achievement of therapeutic targets in real-world clinical practice in most patients (by month 12 – in 78.4%). In our observation trial the proportion of patients who require every 2 week administration was insignificant and included no more than 3% over 12 months of therapy. Therapy is accompanied by a significant reduction in the need for GCs and NSAIDs.