Real-world predictors of 12-month intravenous abatacept retention in patients with rheumatoid arthritis in the ACTION observational study

Rieke Alten, Xavier Mariette, Hanns-Martin Lorenz, Mauro Galeazzi, Alain Cantagrel, Hubert G Nüßlein, Melanie Chartier, Yedid Elbez, Christiane Rauch, Manuela Le Bars, Rieke Alten, Xavier Mariette, Hanns-Martin Lorenz, Mauro Galeazzi, Alain Cantagrel, Hubert G Nüßlein, Melanie Chartier, Yedid Elbez, Christiane Rauch, Manuela Le Bars

Abstract

Introduction: An understanding of real-world predictors of abatacept retention is limited. We analysed retention rates and predictors of abatacept retention in biologic-naïve and biologic-failure patients in a 12-month interim analysis of the 2-yearAbataCepTIn rOutiNe clinical practice (ACTION) study.

Methods: ACTION was an international, observational study of patients with moderate-to-severe rheumatoid arthritis (RA) who initiated intravenous abatacept. In this 12-month interim analysis, crude abatacept retention rates, predictors of retention and European League Against Rheumatism (EULAR) response were evaluated in both biologic-naïve and biologic-failure patients. Retention by rheumatoid factor (RF) and anti-cyclic citrullinated peptide (CCP) status was also assessed, in patients with or without baseline radiographic erosions, and by body mass index (BMI).

Results: Overall, 2350/2364 enrolled patients were evaluable (674 biologic naїve; 1676 biologic failure). Baseline characteristics were largely similar in biologic-naïve and biologic-failure groups. Crude retention rates (95% CI) at 12 months were significantly higher in biologic-naїve (78.1%(74.7% to 81.2%)) versus biologic-failure patients (69.9%(67.6% to 72.1%); P<0.001). RF/anti-CCP double positivity predicted higher retention in both patient groups, and remained associated with higher retention in patients with erosive disease. BMI did not impact abatacept retention in either patient group, irrespective of RF/anti-CCP serostatus. Good/moderate EULAR response rate at 12 months was numerically higher in biologic-naїve (83.8%) versus biologic-failure (73.3%) patients. There were no new safety signals.

Conclusion: High levels of intravenous abatacept retention in clinical practice were confirmed, particularly in biologic-naïve patients, including in those with poor RA prognostic factors. Retention was unaffected by BMI, regardless of RF/anti-CCP serostatus.

Trial registration number: NCT02109666; retrospectively registered 8 April 2014.

Keywords: ant-ccp; dmards (biologic); rheumatoid arthritis; rheumatoid factor.

Conflict of interest statement

Competing interests: RA: grant/research support: Bristol-Myers Squibb; consultant: Bristol-Myers Squibb; speakers bureau: Bristol-Myers Squibb. XM: grant/research support: Biogen, GSK, Pfizer; speakers bureau: Bristol-Myers Squibb, GSK, Pfizer, sanofi, UCB. HML: consultant: AbbVie, Bristol-Myers Squibb, Roche-Chugai, UCB, MSD, GSK, Sobi, Medac, Novartis, Janssen-Cilag, AstraZeneca, Pfizer, Actelion; speakers bureau: AbbVie, Bristol-Myers Squibb, Roche-Chugai, UCB, MSD, GSK, Sobi, Medac, Novartis, Janssen-Cilag, AstraZeneca, Pfizer, Actelion. MG: none declared. AC: grant/research support: UCB, Pfizer; consultant: AbbVie, Bristol-Myers Squibb, Chugai, Lilly, MSD, Novartis, Pfizer, Roche. HGN: consultant: Bristol-Myers Squibb, AbbVie, Celgene, Janssen, Eli Lilly, Pfizer, MSD, Novartis, Roche; speakers bureau: Bristol-Myers Squibb, AbbVie, Celgene, Janssen, Eli Lilly, Pfizer, MSD, Novartis, Roche. MC: employee: Bristol-Myers Squibb. YE: consultant: Bristol-Myers Squibb. CR: shareholder and employee: Bristol-Myers Squibb. MLB: shareholder and employee: Bristol-Myers Squibb at time of study.

Figures

Figure 1
Figure 1
(A) Crude retention rate over 12 months of abatacept treatment and (B) crude retention rate over 12 months of abatacept treatment by line of treatment. TNF, tumour necrosis factor.
Figure 2
Figure 2
Multivariable model of abatacept retention in biologic-naïve patients. P values are pooled across each category. HRs are significant when the 95% CIs do not overlap 1. *Neoplasms were mainly endocrine and breast cancer. †Psychiatric disorders were mainly depression. CCP, cyclic citrullinated peptide; RF, rheumatoid factor.
Figure 3
Figure 3
Multivariable model of abatacept retention by RF and anti-CCP status in biologic-naïve patients with or without radiographic erosion at baseline. P values are pooled across each category. HRs are significant when the 95% CIs do not overlap 1. CCP, cyclic citrullinated peptide; RF, rheumatoid factor.
Figure 4
Figure 4
Multivariable model of abatacept retention in biologic-failure patients. P values are pooled across each category. HRs are significant when the 95% CIs do not overlap 1. CCP, cyclic citrullinated peptide; DMARD, disease-modifying antirheumatic drug; MTX, methotrexate; RF, rheumatoid factor; VAS, Visual Analogue Scale.
Figure 5
Figure 5
Percentage of patients achieving EULAR response* at 12 months by treatment line. n represents the number of patients with available data. *EULAR response was based on 28-joint Disease Activity Score, erythrocyte sedimentation rate or C reactive protein (collected). †Biologic-naïve versus biologic-failure patients who achieved a good or moderate EULAR response (83.8% vs 73.3%, P<0.001). EULAR, European League Against Rheumatism.

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