Efficacy and tolerability of abatacept treatment: results of 12 months observation

• Published in: Terapevtic̆eskii arhiv Vol. 90; no. 5; pp. 44 - 49
• Main Authors: Borisova, M A, Lukina, G V, Sigidin, Y A, Aronova, E S, Luchihina, E L, Karateev, D E, Glukhova, S V, Nasonov, E L
• Format: Journal Article
• Language: English; Russian
• Published: Russia (Federation) "Consilium Medicum" Publishing house 11.05.2018
• Subjects: abatacept; biologics; retention rate; rheumatoid arthritis; “biologic-naive” pts; biologics; rheumatoid arthritis; abatacept; retention rate; “biologic-naive” pts
• ISSN: 0040-3660; 2309-5342
• DOI: 10.26442/terarkh201890544-49

This article reports 1-year clinical outcomes of patients with rheumatoid arthritis (RA) receiving abatacept (ABA) therapy. Patients (n=91) with high RA activity (DAS28 = 5.1 ± 1.0) and an inadequate response on synthetic DMARDs (mainly methotrexate, 70.3%) and biologics (mainly TNF-α inhibitors, 93%) were included in the study. The majority of patients were middle-aged (49 ± 13.5) womens, RF (72.5%) and ACPA (77%) positive, with moderate functional impairment - HAQ = 1.4 (0.9-2). ABA were administered IV, 10 mg/kg according to the standard scheme. The evaluation of the effectiveness of the therapy was carried out according to the EULAR / ACR 2011 criteria using SDAI, CDAI, HAQ and the intention to treat approach. ABA led to a significant (p <0.05) decrease activity of RA. Clinical improvement according to EULAR criteria after 6 months of treatment was registered in 70.9%, after 12 months 63%. Almost a third of patients (28.7%) achieved a good response after 3 months of therapy, 39,2% - after 6 months and 39% - after 12 months. The retention rate of ABA therapy after 6 months was 77%, after 12 months - 60%. There were no significant differences between "bio-naive", 1 Bio and ≥2 Bio groups in achieving EULAR response. A good response was achieved in 38%, 38% and 43%, respectively, but the lowest number of non-responders was registered in ≥2 Bio - 38%, 36% and 43%. ABA significantly improved functional status of patients, after 12 months a marked and moderate improvement in the HAQ was achieved in 39% and 21% of patients, respectively. Adverse events (AE) were registered in 22 patients. The most frequent AE were upper respiratory tract infections - 11 (12%) patients. Abatacept was effective in the overall population, and in all subgroups of patients. It has shown significant improvement of clinical and functional status in patients who had an inadequate response to previous therapy. ABA has a good safety profile. AE were registered only in a small number of patients.