ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2491

Prognostic Factors for IV Abatacept Retention in Patients Who Have Received at Least One Prior Biologic Agent: 2-Year Results from a Prospective, International, Real-World Study

H Nüßlein1, R Alten2, M Galeazzi3, HM Lorenz4, MT Nurmohamed5, WG Bensen6, Gerd Burmester7, H-H Peter8, P Peichl9, K Pavelka10, M Chartier11, C Poncet12, C Rauch13 and M Le Bars14, 1Internistische Schwerpunktpraxis, Nürnberg, Germany, 2Schlosspark-Klinik University Medicine, Berlin, Germany, 3University of Siena, Siena, Italy, 4University Hospital, Heidelberg, Germany, 5VU Univ Medical Center/Jan van Breeman Research Institute, Amsterdam, Netherlands, 6St Josephs Hospital and McMaster University, Hamilton, ON, Canada, 7Charité-Universitätsmedizin, Berlin, Germany, 8University of Freiburg, Freiburg, Germany, 9Evangelisches Krankenhaus, Vienna, Austria, 10Institute of Rheumatology, Prague, Czech Republic, 11Chiltern International, Neuilly, France, 12Docs International, Nanterre, France, 13Bristol-Myers Squibb, Munich, Germany, 14Bristol-Myers Squibb, Rueil-Malmaison, France

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: ,

Session Information

Session Title: Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy: Therapeutic Strategies, Biomarkers and Predictors of Outcomes in Rheumatoid Arthritis

Session Type: Abstract Submissions (ACR)

Background/Purpose: To identify prognostic factors of retention for abatacept (ABA) treatment in patients (pts) with moderate-to-severe RA, using final results from the real-world ACTION study. Methods: ACTION was a 2-year follow-up, non-interventional, international, multicenter, cohort study that evaluated retention and effectiveness of IV ABA in adults with moderate-to-severe RA in Europe and Canada (May 2008–Jan 2011). Socio-demographics, disease characteristics, previous/concomitant therapies, and comorbidities at ABA initiation were considered potential prognostic variables of retention. Pts who had received ≥1 prior biologic agent in countries with sufficient pt numbers to explore between-country effects were included. Clinically relevant variables, known risk factors and prognostic factors with a p≤0.10 (univariate analysis) were entered into a multivariate Cox proportional hazards regression model, with clustered data adjusted for one investigator. Factors with p≤0.10 after backward selection were retained in the final model. Co-linearity and interactions were assessed. Additional analysis to account for missing data in covariates was performed using multiple imputation by chained equations.

Results: 1009/1131 (89.2%) evaluable pts had failed ≥1 prior biologic agent. The crude retention rate (95% CI) at 24 months (Kaplan–Meier method) for pts exposed to ≥1 prior biologic agent was 53.4% (50.1, 56.6%).1 995 of 1009 pts were included in the analysis of prognostic factors. Final multivariate model results (n=916) are shown in the Figure. Pts had significantly higher likelihood of ABA retention if they were both RF and ACPA positive or had cardiovascular comorbidity at initiation. Prior anti-TNF agents, high baseline ESR and corticosteroid (CS) use were also prognostic factors for discontinuation. Despite showing borderline significance in the first model (Figure), use of a non-anti-TNF biologic agent before ABA (n=143, 15.6%) was an additional prognostic factor of lower retention (1.29 [1.00, 1.66]; p=0.049) in the model with imputation of missing data (not shown). Disease duration, ABA monotherapy and BMI were not identified as prognostic factors.

PoncetC_All Author Approval_ForestPlot_RiskRel.gif

Conclusion: ACTION is one of the first studies to identify and report prognostic factors of long-term abatacept retention in a real-world setting. Double ACPA and RF positivity and cardiovascular comorbidity at initiation were prognostic of higher retention. Consistent with other reports,2,3 higher number of prior anti-TNFs, country and more severe disease (suggested by higher baseline ESR and introduction of CS) were identified as prognostic factors of lower retention. These results will support individualized biologic treatment strategies in pts with moderate-to-severe RA.

1. Nüßlein H, et al. Ann Rheum Dis 2014;73:(S2):FRI0318.

2. Finckh A, et al. Arthritis Rheum 2013;65(S10):S217.

3. Neto D, et al. Arthritis Rheum 2013;65(S10):S1248.  

Disclosure:

H. Nüßlein,

Bristol-Myers Squibb, Abbott, Chugai, UCB, Essex, Wyeth, Pfizer, MSD, Novartis and Roche,

5;

R. Alten,

Bristol-Myers Squibb,

2,

Bristol-Myers Squibb,

5;

M. Galeazzi,
None;

H. Lorenz,

Bristol-Myers Squibb,

5;

M. Nurmohamed,

BMS, Janssen,

5,

Roche, Abbvie, Pfizer, UCB,

8,

Roche, Abbvie, Pfizer, MSD, UCB, BMS,

2;

W. Bensen,

Abbott, Amgen, BMS, Janssen, Merck, Lilly, Novartis, Pfizer, Proctor and Gamble, Roche, Sanofi -Aventis, Schering, Takeda, UCB, Warner Chilcott, Wyeth,

2,

Abbott, Amgen, BMS, Janssen, Merck, Lilly, Novartis, Pfizer, Proctor and Gamble, Roche, Sanofi -Aventis, Schering, Takeda, UCB, Warner Chilcott, Wyeth,

5,

Abbott, Amgen, BMS, Janssen, Merck, Lilly, Novartis, Pfizer, Proctor and Gamble, Roche, Sanofi -Aventis, Schering, Takeda, UCB, Warner Chilcott, Wyeth,

8;

G. Burmester,

AbbVie, Pfizer, Roche, UCB,

2,

AbbVie, BMS, MSD, Medimmune, Novartis, Pfizer, Roche, Sandoz, UCB,

5,

AbbVie, BMS, MSD, Pfizer, Roche, Sandoz, UCB,

8;

H. H. Peter,
None;

P. Peichl,
None;

K. Pavelka,

MSD, AbbVie, Pfizer, UCB, Roche, Amgen, Menarini, BMS,

5;

M. Chartier,
None;

C. Poncet,

Bristol-Myers Squibb,

9;

C. Rauch,

Bristol-Myers Squibb,

3;

M. Le Bars,

Bristol-Myers Squibb,

3,

Bristol-Myers Squibb,

1.

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