[Efficacy and safety of levilimab in the treatment of patients with rheumatoid arthritis].

Aim: Evaluation in real clinical practice of the effectiveness and safety of levilimab therapy in patients with highly and moderately active rheumatoid arthritis (RA).

Materials and methods: A prospective observational study (6 months) involving 35 patients with RA (29 women and 6 men, mean age 53.17±13.2 years) who were treated at the Ochapovsky Regional Clinic Hospital of Krasnodar Region. All patients included in the study were prescribed the drug levilimab (Ilsira).

Results: After 1 month of observation, there was a decrease in the clinical and laboratory activity of the process in the form of a decrease in the number of painful joints - 17.0 (14.0; 20.0) vs 8.0 (6.0; 10.0); p=0.000001, number of swollen joints - 3.0 (2.0; 4.0) vs 0.0 (0.0; 0.0); p=0.000002, reduction in pain intensity according to visual analog scale - 60.0 (60.0; 70.0) mm vs 30.0 (20.0; 40.0) mm (p=0.000001). Also, by the end of the first month of therapy, there was a decrease in clinical activity indices DAS28-ESR by 43%, SDAI by 60%, CDAI by 55%. Positive dynamics of laboratory parameters were noted - a decrease in erythrocyte sedimentation rate by 76%, a decrease in C-reactive protein level by 98%. By the 6th month of therapy, a decrease in RF by 36% and ACCP by 11% was recorded, but the dynamics of these indicators did not reach statistical significance. By the end of 4 weeks of treatment, 24 (68.6%) patients showed an increase in the level of total blood cholesterol - 5.1 (3.91; 6.0) mmol/L vs 6.1 (4.99; 7.07) mmol/L (p=0.000006), while 11 (45.8%) patients from this group had initially elevated cholesterol levels (6.4±0.6 mmol/L). In 5 (14.3%) patients, an increase in alanine aminotransferase (ALT) was recorded in the 4th week - 17.0 (11.0; 25.0) U/L vs 32.0 (22.0; 43.0) U/L (p=0.000062) and aspartate aminotransferase (AST) - 19.0 (14.0; 24.0) U/L vs 25.0 (18.0; 36.0) U/L (p=0.000171), in 1 (2.85%) of the patient, an increase in ALT and AST above normal was noted (ALT 144 U/L, AST 52 U/L), which required discontinuation of levilimab. In 2 (5.7%) patients, by the end of the 4th week a decrease in the absolute number of neutrophils was registered - 3.2 (2.6; 4.0)×10E⁹/L vs 2.3 (2.0; 2.5)×10E⁹/L (p=0.002), which did not require discontinuation of treatment, since the number of cells remained more than 1×10E⁹/L. During treatment with levilimab 162 mg subcutaneously once a week, the proportion of patients taking prednisolone decreased from 46% at the start of therapy to 11% at the end of 6 months of therapy.

Conclusion: Levilimab is a highly effective drug for the treatment of patients with highly and moderately active RA and has a favorable tolerability and safety profile.