Evaluation of the efficacy and safety of levilimab in the treatment of patients with rheumatoid arthritis in real practice

Aim. To evaluate the efficacy and safety of levilimab (LVL) in patients with rheumatoid arthritis (RA) in real clinical practice.

Materials and methods. A retrospective observational study of 144 patients with RA and the need to adjust previously prescribed therapy against the background of an exacerbation of the disease, which took place at the Republican Clinical Hospital in Kazan. All patients included in the study were prescribed LVL (Ilsira). The activity of RA was assessed using Disease Activity Score 28 – DAS28-ESR/CRP indices. The assessment was performed before initiation of LVL therapy and at the end of follow-up.

Results. The analysis included 144 patients with RA (112 – women, 32 – men, average age – 55.1±12.3 years). The patients were divided into 3 groups, depending on the duration of follow-up. The first group (up to 4 weeks) – 33 (22.9%) patients, the second group (4–8 weeks) – 75 (52.1%), the third group (more than 8 weeks) – 36 (25%). The duration of follow-up described in the study did not exceed 12 weeks. The assessment was performed before initiation of LVL therapy and at the end of follow-up. In each of the groups, at the time of completion of the observation, there was a decrease in RA activity according to the DAS28-ESR/CRP indices by 6.1% (p=0.000162), 11.1% (p=0.00001) and 27% (p=0.0001) respectively, according to acute phase indicators – ESR by 39.6% (p=0.0001), 55.4% (p=0.0001) and 44.6% (p=0.000028) respectively, CRP decreased by 65.2% (p=0.000196), 71.5% (p=0.0001) and 58.6% (p=0.000707) respectively. At the end of the follow-up, the number of patients with high RA activity decreased by 65.8% (p=0.000022). Against the background of LVL therapy, the proportion of patients taking CS≥7.5 mg/day decreased by 31.4% (p=0.006). LVL's safety profile was assessed as favorable. The registered AE related to deviations in the reference values of laboratory parameters and corresponded to 1 or 2 degrees of severity according to CTCAE version 5.0. No serious AE were reported.

Conclusion. Levilimab has demonstrated high efficacy and a favorable safety profile for RA therapy.