Steroid-sparing effect of levilimab in rheumatoid arthritis in real practice

Aim. Evaluation in real clinical practice steroid-sparing effect of levilimab therapy in patients with highly and moderately active rheumatoid arthritis (RA).

Materials and methods. Retrospective observational study (1 year) held at the Republican Clinical Diagnostic Center for the period from November 2022 to July 2023. All patients received corticosteroids (CS) at the time of levilimab (LVL) administration. The assessment of the decrease in the dosage of CS was carried out at 12, 24 and 52 weeks from the start of LVL-therapy.

Results. The analysis included 73 patients with RA (60 women and 13 men, average age – 56.3±10.5 years), the average dose of CS at the time of LVL initiation was 5.7±2 mg/day with an average duration of CS intake of 87.5 months [7; 137]. Twenty patients included in the follow-up received CS at a dosage of ≥5 mg. Of the 73 patients, by the end of the study, it was possible to achieve a reduction in the dosage of CS in 22 (30.1%) patients, and complete elimination of CS in 36 patients (49.3%). Only 3 patients received CS at a dosage of ≥5 mg after 52 weeks. Against the background of taking LVL, patients showed a decrease in clinical and laboratory activity of RA according to the Disease Activity Score in 28 joints with C-reactive protein indices by 47.1% and Disease Activity Score in 28 joints with Erythrocyte Sedimentation Rate by 48.2%. The positive dynamics of laboratory parameters was noted – a decrease in the level of C-reactive protein by 90.5% and ESR by 72%. During the observation a favorable safety profile of LVL was noted. The most frequently reported adverse event was an increase in alanine aminotransferase and aspartate aminotransferase, recorded in 41 patients (56.1%). One adverse event met the criteria of severity 3 according to Common Terminology Criteria for Adverse Events version 5.0 – lung carcinoma with unspecified cell type, stage 1.

Conclusion. Levilimab is a highly effective therapy option for patients with RA with a favorable tolerability and safety profile, against which an effective dose reduction and complete elimination of steroids is possible.