Efficacy and safety of the biosimilar etanercept in the treatment of patients with rheumatoid arthritis and spondyloarthritis

B. Issayeva, D. S. Dilmanova, A. Amanzholova, S. Issayeva, A. B. Kanapina, А.Е. Туртаева, Gulzhan Trimova

Modern Rheumatology Journal, 2024

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DOI 10.14412/1996-7012-2024-5-65-74
Data confidence 70 medium
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Abstract

Objective: to evaluate the efficacy and safety of the biosimilar etanercept (ETC, Altebrel) in patients with rheumatoid arthritis (RA) and spondyloarthritis (SpA) in clinical practice. Material and methods. The study included 20 patients with a confirmed diagnosis of RA and 8 with SpA: 5 with axial SpA with radiological signs of sacroiliitis (r-axSpA), 3 with peripheral psoriatic arthritis (PsA). The mean age of the patients with RA was 47.7±12.3 years, and the mean age of SpA patients was 40.4±15.9 years. Patients with RA had moderate or high disease activity: mean DAS28-ESR index 5.2±1.0, median CDAI – 22.5 [15.5; 35.0], SDAI – 31.9 [24.4; 38.6], CRP level – 11 [0.9; 32.5] mg/L. Patients with r-axSpA had high activity and functional impairment, the median BASDAI was 5.5 [3.5; 8.0], BASFI – 6 [4; 6], CRP level – 17.5 [12.5; 27] mg/L. In PsA, the average DAS28 was 6.25±0.71. All patients were prescribed Altebrel at a dose of 50 mg subcutaneously weekly against a background of disease-modifying antirheumatic drugs. Patients were examined at baseline and then after 3 and 6 months of treatment. Results and discussion. During treatment with the biosimilar ETC, all patients with RA showed a decrease in inflammatory activity markers: after 3 and 6 months of therapy, the mean DAS28-ESR value decreased to 3.5±1.2 and 2.3±0.7 (p <0.001) the median SDAI value to 19.6 [6.9; 32.5] and 8.4 [4.7; 15.6] (p<0.001), CDAI value to 9.5 [4; 13.0] and 4.5 [3.0; 7.5] (p <0.001), the CRP level – to 5.0 [0.7; 21.9] and 5.0 [2.0; 10.9] mg/L (p<0.001), respectively. Patients with SpA showed a decrease in disease activity and an improvement in functional status: the median BASDAI decreased to 1.0 [0; 2.5] and 0 [0; 1.5], BASFI to 0 [0; 1] and 0 [0; 0], CRP level to 4.5 [2.5; 6.5] and 2.0 [2.0; 2.5] mg/L, respectively. In patients with PsA, DAS28 decreased on average to 2.92±0.12 after 3 months, and after 6 months the values were 1.74 and 2.29 in 2 patients. All patients completed the study and no adverse events were observed during treatment. According to EULAR criteria, a good response was achieved in 40% of patients with RA after 3 months, and in 80% after 6 months, and a satisfactory response in 20%. Patients with r-axSpA showed statistically significant positive dynamics of BASDAI and BASFI indices as well as normalization of laboratory activity parameters. Conclusion. The results of the study demonstrate the high efficacy of Altebrel in rheumatic diseases, including RA and SpA.