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


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Abstract

Objectives: This article reports 1-year clinical outcomes of patients with rheumatoid arthritis (RA) receiving abatacept (ABA) therapy. Materials and methods: 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. Results: 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. Conclusion: 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.

About the authors

M A Borisova

V.A. Nasonova Research Institute of Rheumatology, laboratory of monitoring safety of antirheumatic treatment

Email: mrs.mbrs@yandex.ru
м.н.с., лаб. мониторинга безопасности антиревматических препаратов; https://orcid.org/0000-0002-3674-8518 Moscow, Russia

G V Lukina

V.A. Nasonova Research Institute of Rheumatology, laboratory of monitoring safety of antirheumatic treatment; Moscow Clinical Scientific Center named after Loginov A.S

в.н.с., лаб. мониторинга безопасности антиревматических препаратов; руководитель московского городского ревматологического центра Moscow, Russia

Y A Sigidin

V.A. Nasonova Research Institute of Rheumatology, laboratory of monitoring safety of antirheumatic treatment

в.н.с., лаб. мониторинга безопасности антиревматических препаратов Moscow, Russia

E S Aronova

V.A. Nasonova Research Institute of Rheumatology, laboratory of monitoring safety of antirheumatic treatment

м.н.с., лаб. мониторинга безопасности антиревматических препаратов Moscow, Russia

E L Luchihina

Moscow Regional Research and Clinical Institute (MONIKI)

в.н.с. отд-ния кардиопульмонологии Moscow, Russia

D E Karateev

Moscow Regional Research and Clinical Institute (MONIKI)

главный внештатный специалист-ревматолог, главный н.с. кардиопульмонологического отд-ния Moscow, Russia

S V Glukhova

V.A. Nasonova Research Institute of Rheumatology, laboratory of monitoring safety of antirheumatic treatment

н.с. учебно-методического отдела Moscow, Russia

E L Nasonov

V.A. Nasonova Research Institute of Rheumatology, laboratory of monitoring safety of antirheumatic treatment; I.M. Sechenov First Moscow State Medical University

научный руководитель, акад. РАН, главный внештатный ревматолог, зав. каф. ревматологии ФГБНУ «Научно-исследовательский институт ревматологии им. В.А. Насоновой»; каф. ревматологии института профессионального образования Moscow, Russia

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