Abatacept inhibits progression of structural damage in rheumatoid arthritis: results from the long-term extension of the AIM trial

Abstract

Objective:Assess the effect of abatacept on progression of structural damage over 2 years in patients with rheumatoid arthritis who had an inadequate response to methotrexate.Methods:539 patients entered an open-label extension of the AIM (Abatacept in Inadequate responders to Methotrexate) trial and received abatacept. Radiographic assessment of the hands and feet was performed at baseline, year 1 and year 2. At year 2, each patient’s radiographs were scored for progression blinded to sequence and treatment allocation.Results:In patients treated with abatacept for 2 years, greater reduction in progression of structural damage was observed in year 2 than in year 1. The mean change in total Genant-modified Sharp scores was reduced from 1.07 units in year 1 to 0.46 units in year 2. Similar reductions were observed in erosion and joint space narrowing scores. Following 2 years of treatment with abatacept, 50% of patients had no progression of structural damage as defined by a change in the total score of ⩽0 compared with baseline. 56% of patients treated with abatacept had no progression during the first year compared with 45% of patients treated with placebo. In their second year of treatment with abatacept, more patients had no progression than in the first year (66% vs 56%).Conclusions:Abatacept has a sustained effect that inhibits progression of structural damage. Furthermore, the mean change in radiographic progression in patients treated with abatacept for 2 years was significantly lower in year 2 versus year 1, suggesting that abatacept may have an increasing disease-modifying effect on structural damage over time.

Abatacept in the treatment of patients with psoriatic arthritis: Results of a six‐month, multicenter, randomized, double‐blind, placebo‐controlled, phase II trial

“…Although the MRI methodology has not been validated as an outcome measure for PsA, these results are consistent with the results of radiographic measurements of joint damage previously reported in RA patients treated with abatacept (26). Suppression of joint damage, as assessed by various imaging modalities, has also been reported in PsA patients treated with anti-TNF agents (43)(44)(45).…”

“…No safety events were unique to this patient population. Overall, the safety profile of abatacept in this study was generally similar to that reported in studies of abatacept in RA (25)(26)(27)(28)(29).…”

“…Abatacept selectively inhibits T cell activation via competitive binding to CD80 or CD86 and decreases serum levels of cytokines and inflammatory proteins implicated in the pathogenesis of PsA (24). Abatacept is an approved treatment for chronic inflammatory conditions such as rheumatoid arthritis (RA) and juvenile idiopathic arthritis (JIA), in which T cells are involved in the pathophysiology of the disease (25)(26)(27)(28)(29)(30). In a phase I study of abatacept in patients with psoriasis vulgaris, clinical improvement was associated with a reduction of the intralesional T cell population (31,32).…”

Abatacept: a T-cell co-stimulation modulator for the treatment of rheumatoid arthritis

“…Abatacept demonstrated favorable efficacy in this trial, including inhibition of radiographic progression through 2 years [39], which was not measured in the ATTAIN trial, with an acceptable safety profile. Abatacept is not indicated for use in this patient population in the EU, but it has been approved in other countries, including the USA, for the treatment of patients with moderate to severe RA who have shown an inadequate response to non-biologic DMARDs.…”

Results of the Iv Phase of the Open Clinical Trial on Efficacy and Safety of Abatacept Usage in Children and Adolescents With Polyarticular Juvenile Idiopathic Arthritis Without Systemic Manifestations in Russia

“…Эффективность и безопасность абатацепта исследо-вали в рандомизированных двойных слепых плацебо-контролируемых исследованиях у пациентов в возрасте старше 18 лет с активным ревматоидным артритом, рефрактерных к одному из иммунодепрессантов и/или ингибитору фактора некроза опухоли (ФНО) ␣ [15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33]. Особый интерес представляет рандомизированное двойное слепое плацебоконтролируемое исследование эффективности и безопасности абатацепта, в которое были включены 190 детей в возрасте от 6 до 17 лет с различными вариантами ЮИА (олиго-, полиартрит РФ-и РФ+, системный вариант без системных проявлений) [34].…”