ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2485

Predictors of Drug-Free Remission Following Treatment with Abatacept (in Combination with Methotrexate or as Monotherapy) in Early Rheumatoid Arthritis

P Emery1, Gerd Burmester2, Vivian P. Bykerk3, B Combe4, Daniel E. Furst5, E Barre6, C S Karyekar7, D Wong7 and T W J Huizinga8, 1University of Leeds, Leeds, United Kingdom, 2Charité – University Medicine Berlin, Berlin, Germany, 3Hospital for Special Surgery, Weill Cornell Medical College, New York, NY, 4Monpellier University Hospital, Montpellier, France, 5University of California at Los Angeles, Los Angeles, CA, 6Bristol-Myers Squibb, Braine-L’Alleud, Belgium, 7Bristol-Myers Squibb, Princeton, NJ, 8Leiden University Medical Center, Leiden, Netherlands

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: ,

Session Information

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: In the Phase IIIb, randomized, double-blind, active-controlled AVERT study, abatacept (ABA) + MTX and ABA monotherapy induced protocol-defined DAS remission (DAS28 [CRP] <2.6) in 60.9% and 42.5% of pts with early RA after 12 months (mths) on treatment (vs 45.2% with MTX alone); DAS-defined remission was also maintained in 14.8% and 12.4% of pts 6 mths after rapid withdrawal of all RA treatment (vs 7.8% with MTX alone).1 We further investigated predictors of drug-free DAS-defined remission at 6 mths after ABA withdrawal. Methods: Pts with early RA (active synovitis in ≥2 joints, onset of symptoms ≤2 years) and DAS28 (CRP) ≥3.2, who were anti-CCP2 positive and MTX-naïve, were randomized to weekly SC ABA 125 mg + MTX, ABA monotherapy or MTX alone for 12 mths. At 12 mths, pts with DAS28 (CRP) <3.2 stopped all RA treatment (ABA immediately and MTX and steroids tapered over 1 mth). Co-primary endpoints were the proportion of pts with DAS-defined remission at (i) Mth 12 and at (ii) both Mths 12 and 18, for ABA + MTX versus MTX alone. To assess predictive characteristics of drug-free DAS-defined remission, post hoc analyses were performed in all treatment groups: (i) descriptive analysis of the proportion of pts with DAS-defined remission at both Mths 12 and 18 by baseline characteristic subgroups and (ii) clinical variables were tested individually by logistic regression in a univariate analysis and variables with p<0.20 were entered into a multivariate model. Results: Descriptive analysis showed that in both ABA treatment arms, the proportion of pts with DAS28 (CRP) <2.6 at both Mths 12 and 18 was numerically higher in pts with lower baseline DAS28 (CRP), lower baseline HAQ-DI and shorter symptom duration; these factors were not associated with remission at Mths 12 and 18 in the MTX-alone group). Predictive factors for DAS28 (CRP) <2.6 at both Mths 12 and 18 identified in the univariate analysis are shown in the figure. In the multivariate model, adjusted for corticosteroid use and restricted to pts with DAS28 (CRP) <2.6 at Mth 12, baseline DAS28 (CRP) (OR [95% CI] = 1.676 [1.176, 2.387], p=0.0043) and duration of remission in the first 12 mths while on treatment (0.913 [0.807, 1.033], p=0.1484) were identified as predictors of DA28 (CRP) <2.6 at both Mths 12 and 18. Figure. Predictors of DAS28 (CRP) <2.6 at both Mths 12 and 18 identified by univariate analysis     AVERT remission in WP Forest plot.jpg  

Conclusion: A small but significant number of patients treated with abatacept plus MTX achieved drug-free remission 6 months after drug withdrawal. According to descriptive and multivariate analyses, less severe disease activity at baseline and longer duration in DAS-defined remission on treatment were predictors for drug-free remission following abatacept withdrawal.  

Disclosure:

P. Emery,

AbbVie, BMS, Merck, Pfizer, Roche, Takeda,

5,

AbbVie, BMS, Merck, Pfizer, Roche,

2;

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;

V. P. Bykerk,

Amgen, Pfizer, BMS, Janssen, UCB, Roche/Genentech,

2;

B. Combe,

Pfizer, Roche-Chugai,

2,

BMS, Merck, Pfizer, Roche-Chugai, UCB,

8;

D. E. Furst,

AbbVie, Actelion, Amgen, BMS, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB ,

2,

AbbVie, Actelion, Amgen, BMS, Cytori, Janssen, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB ,

5,

AbbVie, Actelion, UCB,

8;

E. Barre,

Bristol-Myers Squibb,

3;

C. S. Karyekar,

Bristol-Myers Squibb,

3;

D. Wong,

Bristol-Myers Squibb,

1,

Bristol-Myers Squibb,

3;

T. W. J. Huizinga,

Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Crescendo Bioscience, Inc, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough, UCB, Inc., Eli Lilly,

5,

Meteor Board,

6,

EU & Dutch Arthritis Foundation,

2,

Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough,

8,

Abbott Laboratories, Roche,

9.

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