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.