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Abstract Number: 551

Baseline Autoantibodies Preferentially Impact Abatacept Efficacy in Patients with RA Who Are Biologic Naïve: 6-Month Results from a Real-World, International, Prospective Study

R Alten1, HG Nüßlein2, M Galeazzi3, H-M Lorenz4, X Mariette5, A Cantagrel6, M Chartier7, G Desachy8, C Poncet9, C Rauch10 and M Le Bars11, 1Schlosspark-Klinik University Medicine, Berlin, Germany, 2University Erlangen, Nürnberg, Germany, 3University of Siena, Siena, Italy, 4University Hospital, Heidelberg, Germany, 5Université Paris-Sud, Paris, France, 6Purpan Hospital, Toulouse, France, 7Chiltern International, Neuilly, France, 8Excelya, Boulogne-Billancourt, France, 9Docs International, Nanterre, France, 10Bristol-Myers Squibb, Munich, Germany, 11Bristol-Myers Squibb, Rueil-Malmaison, France

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: abatacept and anti-citrullinated protein/peptide antibodies (ACPA), Rheumatoid Factor

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Session Information

Date: Sunday, November 8, 2015

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

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose:
In a recent meta-analysis, neither rheumatoid
factor (RF) nor anti-cyclic citrullinated peptide (anti-CCP) antibody status
were associated with clinical response to treatment with anti-TNF agents.1
In contrast, anti-CCP positivity may be associated with increased abatacept
efficacy in patients (pts) with prior biologic failure2,3 and in
biologic-naïve pts.4 In this analysis, the efficacy of abatacept
after 6 months’ follow-up in biologic-naïve pts enrolled in the ACTION study was
compared in RF/anti-CCP-positive versus -negative pts. Methods: ACTION is a 2-year, international, multicenter,
prospective, observational study evaluating retention and effectiveness of IV abatacept
in pts with RA. Baseline characteristics and clinical outcomes were evaluated
at 6 months and compared for anti-CCP/RF-positive and -negative pts who were
biologic naïve using analysis of variance on ranks for quantitative variables
and Fisher exact tests for qualitative variables. EULAR response was based on
DAS28 (ESR or CRP) and derived from individual core components, as were mean CDAI
and Boolean remission. Results: In 672 biologic-naïve pts, RF
status was reported in 577 (86%) pts (412 [71%] positive) and anti-CCP antibody
status in 552 (82%) pts (364 [66%] positive); 308/511 (60%) pts were double
positive and 127/511 (25%) pts were double negative. Clinical outcomes at 6
months were more beneficial for pts who were RF or anti-CCP positive versus
negative, including EULAR good or moderate response versus no response (Figure);
mean (95% CI) CDAI (calculated) (RF: 10.8 [9.8, 11.8] vs 15.3 [13.4, 17.2]; p<0.001;
anti-CCP: 10.9 [9.8, 12.0] vs 14.3 [12.4, 16.2]; p=0.002) and Boolean remission
(RF: 13.3% vs 4.0%; p=0.008; anti-CCP: 12.5% vs 6.3%; p=0.096). Similarly, significant
differences in clinical outcomes were observed for pts who were RF/anti-CCP single
positive or double positive versus double negative, respectively, including
EULAR good or moderate response versus no response (Figure); mean (95% CI) CDAI
(calculated) (11.1 [10.2, 12.1] and 10.5 [9.3, 11.6] vs 14.5 [12.3, 16.7];
p=0.003 and p=0.001, respectively) and Boolean remission (12.3% and 13.8% vs
3.8%; p=0.025 and p=0.013, respectively).    74011C_Figure01 Conclusion: These are the first prospective real-world data showing
superior efficacy of abatacept in biologic-naïve pts who are RF and/or anti-CCP
positive versus negative, even when using stringent remission criteria. The
association between autoantibody status and clinical outcomes with abatacept
may be linked to the mechanism of action.   1. Lv Q,
et al. PLoS One 2014;9:e89442. 2.
Gottenberg JE, et al. Ann Rheum Dis 2012;71:1815–9. 3. Fujii
T, et al. Arthritis Rheum 2013;65(Suppl.10):465.  

Disclosure: R. Alten, Bristol-Myers Squibb, 2,Bristol-Myers Squibb, 5,Bristol-Myers Squibb, 8; H. Nüßlein, Bristol-Myers Squibb, Abbvie, Chugai, UCB, Wyeth, Pfizer, MSD, Novartis and Roche, 5,Bristol-Myers Squibb, Abbvie, Chugai, UCB, Wyeth, Pfizer, MSD, Novartis and Roche, 8; M. Galeazzi, None; H. M. Lorenz, Abbvie, BMS, Roche-Chugai, UCB, MSD, GSK, SOBI, Medac, Novartis, Janssen-Cilag, Astra-Zeneca, Pfizer, Actelion, 5,Abbvie, BMS, Roche-Chugai, UCB, MSD, GSK, SOBI, Medac, Novartis, Janssen-Cilag, Astra-Zeneca, Pfizer, Actelion, 8; X. Mariette, BMS, GSK, Pfizer, UCB, 8; A. Cantagrel, UCB, Pfizer, 2,Abbvie, BMS, Lilly, MSD, Novartis, Pfizer, Roche, 5; M. Chartier, None; G. Desachy, Bristol-Myers Squibb, 1,Bristol-Myers Squibb, 3; C. Poncet, Bristol-Myers Squibb, 9; C. Rauch, Bristol-Myers Squibb, 1,Bristol-Myers Squibb, 3; M. Le Bars, Bristol-Myers Squibb, 1,Bristol-Myers Squibb, 3.

To cite this abstract in AMA style:

Alten R, Nüßlein H, Galeazzi M, Lorenz HM, Mariette X, Cantagrel A, Chartier M, Desachy G, Poncet C, Rauch C, Le Bars M. Baseline Autoantibodies Preferentially Impact Abatacept Efficacy in Patients with RA Who Are Biologic Naïve: 6-Month Results from a Real-World, International, Prospective Study [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/baseline-autoantibodies-preferentially-impact-abatacept-efficacy-in-patients-with-ra-who-are-biologic-naive-6-month-results-from-a-real-world-international-prospective-study/. Accessed .
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