ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2349

Abatacept and Anti-Tumor Necrosis Factor Monoclonal Antibodies: Efficacy and Safety Comparisons

M Schiff1, Maxime Dougados2, Roy Fleischmann3, J Fay4 and M Maldonado4, 1University of Colorado, Denver, CO, 2Rheumatology, Hopital Cochin, Descartes University, Paris, France, 3University of Texas Southwestern Medical Center, Dallas, TX, 4Bristol-Myers Squibb, Princeton, NJ

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: ,

Session Information

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

Session Type: Abstract Submissions (ACR)

Background/Purpose: A paucity of clinical trial data exists comparing the efficacy and safety of biologic therapies for RA. This study evaluated remission rates and safety for patients (pts) treated with SC or IV abatacept compared with the anti-TNF monoclonal antibodies, adalimumab and infliximab, in a post hoc, cross-trial comparison. Methods: In the head-to-head AMPLE study,1 pts were randomized to SC abatacept (125 mg weekly) or SC adalimumab (40 mg biweekly), plus background MTX. In the double-blind, double-dummy, placebo- and active-controlled ATTEST study,2 pts were randomized 3:3:2 to IV abatacept (~10 mg/kg every 4 weeks), infliximab (3 mg/kg every 8 weeks), or placebo, plus background MTX. Pts in both trials had active RA with inadequate response to MTX and were biologic naïve. Remission according to DAS28 (CRP) and SDAI was evaluated post hoc over 12 months of treatment for all randomized and treated pts with data available at the visit of interest. Safety was evaluated for all pts who received ≥1 dose of study drug. Results: In AMPLE, 318 and 328 pts received SC abatacept and adalimumab, respectively; in ATTEST, 156 pts received IV abatacept and 165 received infliximab. Baseline DAS28 (CRP) scores (mean±SD) were 5.5±1.1 in AMPLE and 6.4±0.9 in ATTEST. Duration of RA was 1.9±1.4 and 1.7±1.4 years for SC abatacept and adalimumab in AMPLE, and 7.9±8.5 and 7.3±6.2 years for IV abatacept and infliximab in ATTEST. Remission rates over 12 months were similar for treatment groups in each trial (Table). Over 12 months, 11 (3.5%) vs 20 (6.1%) SC abatacept- vs adalimumab-treated pts, and 4 (2.6%) vs 12 (7.3%) IV abatacept- vs infliximab-treated pts discontinued due to adverse events (AEs); 32 (10.1%) vs 30 (9.1%) and 15 (9.6%) vs 30 (18.2%) experienced SAEs; 5 (1.6%) vs 4 (1.2%) and 1 (0.6%) vs 2 (1.2%) had malignancy; 10 (3.1%) vs 4 (1.2%) and 2 (1.3%) vs 1 (0.6%) experienced autoimmune events. Serious infections were reported in 7 (2.2%) vs 9 (2.7%) and 3 (1.9%) vs 14 (8.5%) pts treated with SC abatacept vs adalimumab in AMPLE and IV abatacept vs infliximab in ATTEST, respectively, with 0/7 vs 5/9 and 0/3 vs 4/14 serious infections leading to discontinuation, and opportunistic infections for 1 (0.3%) vs 1 (0.3%) and 0 vs 5 (3.0%).

    AMPLE ATTEST
  Month SC abatacept Adalimumab IV abatacept Infliximab
DAS28 remission 3 26.8 26.0 11.8 19.0
6 30.6 38.1 20.0 25.2
9 39.6 43.1 30.8 23.0
12 43.3 41.9 29.9 21.4
SDAI remission 3 10.4 10.7 4.6 6.3
6 13.2 16.6 9.0 10.6
9 17.6 23.9 11.9 12.8
12 23.3 24.8 13.1 11.4

Conclusion: Greater proportions of pts in the AMPLE trial achieved remission outcomes vs ATTEST; however, pts in AMPLE had shorter disease duration and lower disease activity at baseline. Over time both routes of abatacept administration provided similar remission rates to the anti-TNF therapies, regardless of disease duration. Safety outcomes were mostly balanced, with increased SAEs and serious infections for infliximab vs abatacept, and increased discontinuations due to AEs and serious infections in both anti-TNF groups vs abatacept. This analysis provides comparative insight into the efficacy and safety of these biologic agents.

1. Weinblatt ME. Arthritis Rheum 2013;65:28–38; 2. Schiff M. Ann Rheum Dis 2008;67:1096–103.  

Disclosure:

M. Schiff,

Bristol-Myers Squibb,

5,

ABBVIE,

5;

M. Dougados,

Bristol-Myers Squibb,

2,

Bristol-Myers Squibb,

8;

R. Fleischmann,

Baistol-Myers Squibb, Abbvie,

5,

Bristol-Myers Squibb, Abbvie,

2;

J. Fay,

Bristol-Myers Squibb,

1,

Bristol-Myers Squibb,

3;

M. Maldonado,

Bristol-Myers Squibb,

1,

Bristol-Myers Squibb,

3.

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