ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 460

Real-World Efficacy and Safety of Abatacept Treatment for Rheumatoid Arthritis: 12-Month Interim Analysis of the Action Study

H. Nüßlein1, R. Alten2, M. Galeazzi3, H. M. Lorenz4, Dimitrios Boumpas5, M. T. Nurmohamed6, W. Bensen7, Gerd Burmester8, H.-H. Peter9, F. Rainer10, Karel Pavelka11, M. Chartier12, C. Poncet13, C. Rauch14 and M. Le Bars15, 1University Erlangen, Nürnberg, Germany, 2Schlosspark-Klinik, University Medicine, Berlin, Germany, 3University of Siena, Siena, Italy, 4University Hospital Heidelberg, Heidelberg, Germany, 5Panepistimio Kritis, Rethymnon, Greece, 6VU University Medical Center/Jan van Bremen Research Institute, Amsterdam, Netherlands, 7St. Joseph's Hospital and McMaster University, Hamilton, ON, Canada, 8Charité-Universitätsmedizin, Berlin, Germany, 9University Medical Center Freiburg, Freiburg, Germany, 10Hospital Barmherzige Brueder, Graz, Austria, 11Institute of Rheumatology, Prague, Czech Republic, 12Chiltern International, Neuilly, France, 13Docs International, Sévres, France, 14Bristol-Myers Squibb, Munich, Germany, 15Bristol-Myers Squibb, Rueil Malmaison, France

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: ,

Session Information

Title: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy

Session Type: Abstract Submissions (ACR)

Background/Purpose: Randomized controlled trials (RCTs) of abatacept (ABA) in patients (pts) with RA have demonstrated sustained, long-term efficacy, high pt retention, and consistent safety.1 Data from the clinical setting can determine if benefits translate into the real world. We evaluate 1-yr retention, efficacy and safety of ABA in RA pts treated in routine clinical practice (according to label at time of enrollment) in Europe and Canada. Methods: AbataCepT In rOutiNe clinical practice (ACTION) is an ongoing, non-interventional, prospective cohort of ABA-treated RA pts with inadequate response to MTX or anti-TNF therapy in Europe and Canada, initiated Mar 2008.2 At data cut-off in Feb 2012, all pts had reached 1-yr follow-up. Retention rate (Kaplan–Meier estimate) and disease activity (EULAR response) are reported over 12 mths for pts on treatment and with available data, according to whether pts received ABA as a first biologic, or after failure of 1 or ≥2 anti-TNFs. Safety is reported for all enrolled pts, up to data cut-off.

Results: 1138 pts were enrolled and 1120 were evaluable. 1000 (89.3%) had previously failed on biologic treatment, 982/1000 (98.2%) of whom failed ≥1 anti-TNF agent. 120 (10.7%) had not received biologic treatment prior to ABA initiation. Baseline characteristics for the three groups are shown in the Table. Retention rates, reasons for discontinuation and % moderate and good EULAR responders at Mth 12 are presented for ABA when used as the first biologic, first switch agent, and after ≥2 anti-TNFs, and suggest that earlier usage results in higher pt retention (Table). 106 serious adverse events were reported in 60/1138 (5.3%) pts (21 discontinuations). 11 deaths were reported, including 3 due to serious infections (sepsis [4 mths after last ABA infusion; pt was receiving tocilizumab]; Pneumocystis jiroveci [4 mths after last ABA infusion, pt had deep vein thrombosis]; and urosepsis) unrelated to ABA. 23 pts experienced serious infections; 9 malignancies; 5 serious cardiac disorders; and 3 serious vascular disorders. No TB occurred, two opportunistic infections were reported (cytomegalovirus and P. jiroveci).

Conclusion: This large-scale, international, observational real-life study showed that the use of ABA as the first biologic in MTX-inadequate responders, or after first or later switching from anti-TNFs, was associated with good pt retention over 12 mths, particularly when used earlier in the course of treatment. ABA was clinically effective and well tolerated. These data are consistent with previous RCT findings,1,3 and national registry data for biologics.4-6   1. Genovese M, et al. N Engl J Med 2005;353:1114–23 2. Nüßlein H, et al. Ann Rheum Dis 2011;70(Suppl 3):464 3. Kremer JM, et al. Ann Intern Med 2006;144:865–76 4. Leffers HC, et al. Ann Rheum Dis 2011;70:1216–22 5. Gomez-Reino J, et al. Arthritis Res Ther 2006;8:R29 6. Lindblad S, et al. Ann Rheum Dis 2012;71(Suppl 3):383  

Baseline characteristics

ABA first biologic

n=120

ABA first switch (1 previous anti-TNF)

n=481

ABA after ≥2 previous anti-TNFs

n=501

Mean age (SD), years

59.0 (13.8), n=120

56.2 (12.4), n=481

56.0 (12.4), n=501

Mean RA duration (SD), years

7.0 (7.8), n=118

9.8 (8.0), n=465

13.1 (9.4), n=484

≥1 CV risk or comorbidity, n (%)

86 (71.7%), n=120

336 (69.9%), n=481

365 (72.9%), n=501

Mth 12 outcomes

 

 

 

Retention, Kaplan–Meier estimate (95% CI)

83.6% (74.9, 89.5)

73.2% (68.8, 77.2)

64.1% (59.5, 68.4)

Discontinuation for lack of efficacy, n (%)

11 (9.2%), n=120

75 (15.6%), n=481

101 (20.2%), n=501

Discontinuation for intolerance, n (%)

3 (2.5%), n=120

11 (2.3%), n=481

15 (3.0%), n=501

Good EULAR response

34.5%, n=29

34.5%, n=194

27.3%, n=165

Moderate EULAR response

37.9%, n=29

41.8%, n=194

45.5%, n=165

EULAR response criteria: Moderate/good=DAS28 improvement of ≥0.6 and a DAS28 of ≤5.1; Good=DAS28 improvement of >1.2 and a DAS28 of <3.2; Moderate=DAS28 improvement of >1.2 and a DAS28 of ≥3.2, or DAS28 improvement of 0.6–1.2 and a DAS28 of ≤5.1

 

Disclosure:

H. Nüßlein,

Bristol-Myers Squibb,

5,

Bristol-Myers Squibb,

8;

R. Alten,

Abbott, Bristol Myers-Squibb, Novartis, Pfizer, UCB,

2,

Abbott, Bristol Myers-Squibb, Novartis, Pfizer, UCB,

5,

Abbott, Bristol Myers-Squibb, Novartis, Pfizer, UCB,

8;

M. Galeazzi,
None;

H. M. Lorenz,

BMS, Abbott, MSD, Pfizer, UCB, Roche, GSK, Medac, Chugai, Novartis, Sanofi Aventis,

5,

BMS, Abbott, MSD, Pfizer, UCB, Roche, GSK, Medac, Chugai, Novartis, Sanofi Aventis,

8;

D. Boumpas,
None;

M. T. Nurmohamed,

MBS, MSD, Roche, Abbott, Pfizer and UCB,

5,

MBS, MSD, Roche, Abbott, Pfizer and UCB,

8;

W. Bensen,

Abbott, Amgen, Bristol Myers Squibb, Janssen, Merck-Schering, Lilly, Novartis, Pfizer, Wyeth, Proctor and Gamble, Roche, Sanofi, Servier, Aventis, UCB, Warner Chilcott,

5;

G. Burmester,

Abbott, BMS, MSD, Pfizer, Roche, MSD,

2,

Abbott, BMS, MSD, Pfizer, Roche, MSD,

5,

Abbott, BMS, MSD, Pfizer, Roche, MSD,

8;

H. H. Peter,
None;

F. Rainer,
None;

K. Pavelka,

Abbott, Roche, Pfizer, UCB, BMS, Sanofi Aventis,

5,

Abbott, Roche, Pfizer, UCB,

8;

M. Chartier,
None;

C. Poncet,
None;

C. Rauch,

BMS,

3;

M. Le Bars,

Bristol-Myers Squibb,

1,

Bristol-Myers Squibb,

3.

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