Up to 5-year retention of abatacept in Belgian patients with moderate-to-severe rheumatoid arthritis: a sub-analysis of the international, observational ACTION study

Abstract

Favorable efficacy and safety profiles have been demonstrated for abatacept in patients with rheumatoid arthritis (RA) in randomized controlled trials, but these data require validation during long-term follow-ups in routine clinical practice. This study explored long-term safety and retention rates in RA patients treated with intravenous abatacept in the Belgian cohort of the international AbataCepT In rOutiNe clinical practice (ACTION) study (NCT02109666). This non-interventional, observational, longitudinal study included Belgian patients aged ≥ 18 years with moderate-to-severe RA who started intravenous abatacept treatment as first- or second/further-line biologic therapy in routine clinical practice. Between October 2010 and December 2012, 141 patients were enrolled in this cohort, of whom 135 evaluable patients (6 biologic-naïve; 129 previously exposed to ≥ 1 prior biologic disease modifying anti-rheumatic drugs) were eligible for the descriptive analysis; 131/135 were included in the effectiveness analysis. Mean disease duration was 10.5 years (standard deviation 9.7) before abatacept initiation. RA patients presented with high disease activity and comorbidity rate, having failed multiple previous treatment options. In this cohort, the 5-year abatacept retention rate was 34% (95% confidence interval, 23−45%) per protocol, and 51% (95% confidence interval, 40−61%) when temporary discontinuations of abatacept > 84 days ( n = 24) were not considered as treatment discontinuations. After 5 years of abatacept treatment, clinical outcomes were favorable [good/moderate European League Against Rheumatism (EULAR) responses in 91.7% patients]. No new safety signals were detected for abatacept in routine clinical practice. In this difficult-to-treat Belgian RA population, high retention rates, good clinical outcomes and favorable safety profile were observed with abatacept. Electronic supplementary material The online version of this article (10.1007/s00296-020-04619-z) contains supplementary material, which is available to authorized users.

Retention rate of abatacept in rheumatoid arthritis patients in a real-life setting: results from a monocentric cohort

“…On the other hand, in our study, ACPA positivity and the concomitant assumption of MTX were associated with a slightly higher RR at 60 months, even if not statistically signifi- ORIGINAL PAPER cant (Figure 1D, E), likely due to the limited sample size. This data is in accordance with the results of other studies (12)(13)(14)(15).…”

“…In this study, we evaluated the response to ABA in patients with RA through RR, which is considered a good predictor of effectiveness and safety in real-life scenarios. This issue has been evaluated in other studies, which are summarized in Table II (12)(13)(14)(15)(16)(17).…”

“…The majority of studies focusing on ABA survival provide data on 12-month endpoints, including the ACTION study and the French-Ric Network study (13,14). The 12-month RR derived from the studies published so far ranges from 55% to 77% (12)(13)(14)(15)(16).…”

Sustained Long-Term Retention Rates of Abatacept in Combination with Conventional Synthetic Disease-Modifying Antirheumatic Drugs in Elderly Patients with Rheumatoid Arthritis

“…Previously, Lahaye et al have reported that ABT was effective even in RA patients with >75 years in the French cohort (ORA registry), and the risk of severe infection should be considered in such patients [ 3 ]. A Belgian cohort study (sub-analysis of the ACTION study) also showed sustained long-term retention rates (up to 5-year retention) in RA patients treated with ABT [ 9 ]. ABT treatment has been reported to have relatively higher retention rates than other biologics [ 6 , 7 , 8 ].…”

A lesion-selective albumin-CTLA4Ig as a safe and effective treatment for collagen-induced arthritis

“…The use of belatacept, a second-generation CTLA4Ig that differs from the original form by two amino acids, is associated with a high incidence of post-transplant lymphoproliferative disorder in the subsets of kidney transplantation patients [ 8 ]. As a result, patients may discontinue CTLA4Ig therapy due to severe adverse effects [ 9 , 10 ]. Furthermore, CTLA4Ig is associated with an increased incidence of skin cancers [ 11 , 12 ], raising the concern that long-term systemic suppression of T cells by this agent may compromise cancer immunosurveillance.…”