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01.12.2015 | Research article | Ausgabe 1/2015 Open Access

BMC Musculoskeletal Disorders 1/2015

Prognostic factors for abatacept retention in patients who received at least one prior biologic agent: an interim analysis from the observational, prospective ACTION study

Zeitschrift:
BMC Musculoskeletal Disorders > Ausgabe 1/2015
Autoren:
Hubert G. Nüßlein, Rieke Alten, , Mauro Galeazzi, Hanns-Martin Lorenz, Michael T. Nurmohamed, William G. Bensen, Gerd R. Burmester, Hans-Hartmut Peter, Karel Pavelka, Melanie Chartier, Coralie Poncet, Christiane Rauch, Manuela Le Bars
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s12891-015-0636-9) contains supplementary material, which is available to authorized users.

Competing interests

H.G. Nüßlein has received consulting fees and speaker honoraria from Bristol-Myers Squibb, Abbott, Chugai, UCB, Essex, Wyeth, Pfizer, MSD, Novartis, and Roche. R. Alten has received research grants and speaker honoraria from Bristol-Myers Squibb. M. Galeazzi has nothing to disclose. H.-M. Lorenz has received honoraria from Bristol-Myers Squibb, Abbott/Abbvie, Chugai, UCB, Pfizer, MSD, Novartis, sanofi-aventis, SOBI, Janssen-Cilag, and Roche for presentations and participation in advisory boards, and provided advice on planning of the ACTION study. M.T. Nurmohamed has received consultancy fees from Abbott, Roche, Pfizer, MSD, UCB, SOBI, and Bristol-Myers Squibb, and has received payment for lectures from Abbott, Roche, Bristol-Myers Squibb, and Pfizer. W.G. Bensen has attended advisory boards, presented data, and performed research for Bristol-Myers Squibb, Amgen, Abbott, UCB, Merck, Pfizer, Novartis, AstraZeneca, Roche, Janssen, Warner Chilcott, and sanofi-aventis. G.R. Burmester has received consulting fees from Abbott Immunology Pharmaceuticals, Bristol-Myers Squibb, Roche, Merck, and Pfizer; research grants from Abbott Laboratories, Abbott Immunology Pharmaceuticals, Bristol-Myers Squibb, and Roche; and speaker honoraria from Abbott Immunology Pharmaceuticals, Bristol-Myers Squibb, and Roche. H.-H. Peter has nothing to disclose. K. Pavelka has been a speaker for Pfizer, Amgen, MSD, Bristol-Myers Squibb, and Abbott. M. Chartier is a consultant for Bristol-Myers Squibb. C. Poncet is a consultant for Bristol-Myers Squibb. C. Rauch is an employee of Bristol-Myers Squibb. M. Le Bars is an employee of Bristol-Myers Squibb and holds stock options in the company.

Authors’ contributions

HGN made a substantial contribution to the conception and design of the study, to the acquisition of data, and to the analysis and interpretation of data. RA made a substantial contribution to the conception and design of the study, and to the analysis and interpretation of data. MG made a substantial contribution to the acquisition of data, and to the analysis and interpretation of data. H-ML made a substantial contribution to the conception and design of the study, to the acquisition of data, and to the analysis and interpretation of data. MTN made a substantial contribution to the acquisition of data. WGB made a substantial contribution to the acquisition of data. GRB made a substantial contribution to the acquisition of data, and to the analysis and interpretation of data. H-HP made a substantial contribution to the acquisition of data, and to the analysis and interpretation of data. KP made a substantial contribution to the acquisition of data. MC made a substantial contribution to the conception and design of the study, to the acquisition of data, and to the analysis and interpretation of data. CP made a substantial contribution to the conception and design of the study, and to the analysis and interpretation of data. CR made a substantial contribution to the conception and design of the study, and to the analysis and interpretation of data. MLB made a substantial contribution to the conception and design of the study, and to the analysis and interpretation of data. All authors have read and approved the final manuscript.

Abstract

Background

The emergence of new therapies for the treatment of rheumatoid arthritis (RA), the paucity of head-to-head studies, and the heterogeneous nature of responses to current biologics highlight the need for the identification of prognostic factors for treatment response and retention in clinical practice. Prognostic factors for patient retention have not been explored thoroughly despite data for abatacept and other biologics being available from national registries. Real-world data from the ACTION study may supplement the findings of randomized controlled trials and show how abatacept is used in clinical practice. The aim of this interim analysis was to identify prognostic factors for abatacept retention in patients with RA who received at least one prior biologic agent.

Methods

A large, international, non-interventional cohort of patients with moderate-to-severe RA who initiated intravenous abatacept in Canada and Europe (May 2008–January 2011) enrolled in the ACTION study. Potential prognostic factors for retention in this interim analysis (data cut-off February 2012; including patients from Canada, Germany, Greece, and Italy) were baseline demographics and disease characteristics, medical history, and previous and concomitant medication. Clinically relevant variables with p ≤ 0.20 in univariate analysis and no collinearity were entered into a Cox proportional hazards regression model, adjusted for clustered data. Variables with p ≤ 0.10 were retained in the final model (backward selection).

Results

The multivariate model included 834 patients. Anti-cyclic citrullinated peptide (CCP) antibody positivity (hazard ratio [95 % confidence interval]: 0.55 [0.40, 0.75], p < 0.001), failure of <2 prior anti-tumor necrosis factors (TNFs) (0.71 [0.56, 0.90], p = 0.005 versus ≥2 prior anti-TNFs), and cardiovascular comorbidity at abatacept initiation (0.48 [0.28, 0.83], p = 0.009) were associated with lower risk of abatacept discontinuation. Patients in Greece and Italy were less likely to discontinue abatacept than patients in Germany and Canada (Greece: 0.30 [0.16, 0.58]; Italy: 0.50 [0.33, 0.76]; Canada: 1.04 [0.78, 1.40], p < 0.001 versus Germany).

Conclusions

Real-world prognostic factors for abatacept retention include anti-CCP positivity and fewer prior anti-TNF failures. Differences in retention rates between countries may reflect differences in healthcare systems. The finding that abatacept has potential advantages in patients with cardiovascular comorbidities needs to be confirmed in further research.
Zusatzmaterial
Additional file 1: Table S1. List of ethics committee approvals for the ACTION study in countries that enrolled patients between May 2008 and January 2011. (DOCX 28 kb)
12891_2015_636_MOESM1_ESM.docx
Additional file 2: Table S2. Baseline demographics, disease characteristics, comorbidities, and previous and concomitant medications by country (analysis population). Baseline demographics, disease characteristics, comorbidities, and previous and concomitant medications by country in the analysis population. (DOCX 39 kb)
12891_2015_636_MOESM2_ESM.docx
Literatur
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