Abstract
BackgroundDiscontinuation of rheumatoid arthritis (RA) treatment for lack or loss of initial response, tolerability issues, or development of antibodies against the therapeutic agent remains a challenge in clinical practice. Here we present a 6-month interim analysis of a 2-year prospective observational trial in Europe and Canada aiming to assess the real-world effectiveness, safety, and tolerability of intravenous abatacept for the treatment of moderate-to-severe RA.MethodsACTION (AbataCepT In rOutiNe clinical practice) is a prospective, observational study assessing effectiveness, safety, and tolerability of abatacept in patients with RA enrolled in Europe and Canada between May 2008 and January 2011. The patient population was divided into two groups: biologic naïve (‘first-line’) patients and patients who had previously failed treatment with at least one biologic agent (‘second-line’). Retention rates were calculated using Kaplan–Meier curve estimates. Effectiveness was measured using European League Against Rheumatism (EULAR) response criteria, the 28-item Disease Activity Score, the Clinical Disease Activity Index (CDAI), and physical function, as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI). Serious adverse events (SAEs) were reported for all enrolled patients.ResultsOf 1138 consecutively enrolled patients, 1114 and 1079 patients were evaluable for retention and effectiveness, respectively. Overall, retention rates were 88.6% (95% confidence interval [CI]: 86.4, 90.4); 67.4% of patients achieved good/moderate EULAR response; 32.8% had a CDAI Low Disease Activity State (LDAS); and 44.7% a HAQ-DI response. Retention rates among first- and second-line patients were 93.0% (95% CI: 85.9, 96.6) and 88.1% (95% CI: 85.7, 90.0), respectively. The percentage of patients achieving CDAI LDAS was 40.0% (95% CI: 26.4, 53.6) for first- and 32.2% (95% CI: 28.4, 36.0) for second-line patients and the proportion achieving a HAQ-DI response was 60.3% (95% CI: 47.8, 72.9) versus 43.1% (95% CI: 39.0, 47.2), respectively. The incidence of SAEs was 4.7%.ConclusionsEvidence from this 6-month interim analysis suggests that abatacept offers an effective and well-tolerated treatment option for patients with RA, including those who have previously failed anti-tumor necrosis factor treatment. In addition, higher retention rates and effectiveness outcomes were observed when abatacept treatment was initiated earlier in the course of the disease.
Highlights
Discontinuation of rheumatoid arthritis (RA) treatment for lack or loss of initial response, tolerability issues, or development of antibodies against the therapeutic agent remains a challenge in clinical practice
A total of 96.9% (n = 1079/1114) of patients were evaluable for the effectiveness analysis; comprising patients who had a baseline clinical assessment on the same day/day before their first abatacept infusion (68.9% [n = 767]), ≥2 days before their first abatacept infusion (26.2% [n = 292]), ≤ 8 days after their first abatacept infusion (1.4% [n = 16]), and patients with the date of baseline clinical assessment missing (0.4% [n = 4])
The data suggest that patients treated earlier in their disease course with abatacept have better outcomes than patients treated after failure of one or more anti-tumor necrosis factor (TNF) agents
Summary
Discontinuation of rheumatoid arthritis (RA) treatment for lack or loss of initial response, tolerability issues, or development of antibodies against the therapeutic agent remains a challenge in clinical practice. Patients who experience lack of efficacy with one antiTNF agent often have a poorer response to a second or third anti-TNF agent, reflecting loss of efficacy and increased resistance towards TNF-α blockade, which, in some cases is due to the development of anti-therapeutic antibodies [2,3,4,5] This is demonstrated in several large cohort and retrospective studies by longer retention rates for first treatment courses versus subsequent courses (hazard ratio: 2.17; 95% confidence interval [CI]: 1.72, 2.58) and decreased median drug survival times for subsequent antiTNF agents (37 months for first-line agent to 13 months for third-line agent) [3,5]. Recent data suggest that when treatment with an anti-TNF agent shows lack of efficacy, switching to a biologic agent with a different mechanism of action may be of benefit [6]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
