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Abstract Number: 2326

Head-To-Head Comparison Of Subcutaneous Abatacept Versus Adalimumab On Background Methotrexate In RA: Blinded Two Year Results From The Ample (Abatacept Versus Adalimumab Comparison in Biologic-Naive RA Subjectswith Background Methotrexate) study

Michael E. Weinblatt1, Michael H Schiff2, Robert Valente3, Désirée M. van der Heijde4, Gustavo Citera5, Ayanbola Elegbe6, Michael A Maldonado6 and Roy Fleischmann7, 1Division of Rheumatology & Immunology, Brigham and Women's Hospital, Boston, MA, 2University of Colorado, Denver, CO, 3Arthritis Center of Nebraska, Lincoln, NE, 4Dept of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, 5Rheumatology, Instituto de Rehabilitación Psicofísica, Buenos Aires, Argentina, 6Bristol-Myers Squibb, Princeton, NJ, 7University of Texas Southwestern Medical Center, Dallas, TX

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: Abatacept, adalimumab and rheumatoid arthritis (RA), Biologic agents

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Session Information

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

Session Type: Abstract Submissions (ACR)

Background/Purpose: AMPLE (Abatacept Versus Adalimumab Comparison in Biologic-Naive RA Subjects with Background Methotrexate) is the first 2 year, active comparator study in RA patients utilizing biologic agents on a background of MTX. At Year 1, SC abatacept (ABA) and adalimumab (ADA) demonstrated comparable efficacy, including radiographic outcomes, with similar safety.[1] Here we report 2 year study results including radiographic outcomes.

Methods: AMPLE is a phase IIIb randomized, investigator-blinded study of 2 years duration with a primary efficacy endpoint at Day 365. Biologic-naïve patients with active RA and an inadequate response to MTX were randomized 1:1 to receive 125 mg ABA weekly (without an IV load) or 40 mg ADA bi-weekly, with a stable dose of MTX.1 Study conduct continued unchanged from Year 1, including investigator blinding; all clinical efficacy endpoints were captured through Day 729 including radiographs assessed using the van der Heijde modified Total Sharp score (mTSS). All efficacy analyses were done using the intent-to-treat population with non-responder imputation where appropriate. All radiographs were read through Day 729, including re-reading Year 1 images, by readers blinded to treatment allocation and sequence.

Results: Baseline characteristics of the 646 patients, equally randomized to each group, were similar as previously reported.1 79.2% (252 of 318) ABA patients and 74.7% (245 of 328) ADA patients completed Day 729. At Year 1, 64.8% ABA and 63.4% ADA patients were ACR20 responders. Consistent with Year 1, clinical efficacy measures and inhibition of radiographic progression were comparable between groups at Year 2 (Table). There were similar rates of AEs, SAEs (13.8% vs. 16.5%), and malignancies (2.2% vs. 2.1%). More autoimmune AEs occurred in the ABA arm (3.8% vs. 1.8%); none were SAEs. Fewer infections (3.8% vs 5.8%) and opportunistic infections (in 3 vs. 5 patients) occurred with ABA including 2 cases of tuberculosis in the ADA arm that led to discontinuation (DC). There were fewer DC due to AEs (3.8% vs. 9.5%), SAEs (1.6% vs. 4.9%), and serious infections (in 0/12 vs. 9/19 patients) in the ABA arm.  Injection site reactions (ISR) occurred less frequently in the ABA arm (4.1% vs. 10.4%).

Conclusion: Through 2 years of treatment, in this first active comparator study between biologic agents in RA patients with an inadequate response to MTX, this robust data set demonstrates that SC abatacept and adalimumab were equally efficacious in clinical, functional and radiographic outcomes. Overall, the frequency of AEs was similar in both groups but there were less discontinuations due to AEs, SAEs, serious infections, and fewer local ISR in patients treated with SC abatacept.

 

ACR Responses

ABA = 318

ADA = 328

DAS Responses

HAQ

(≥0.3 U)

ABA = 318

ADA = 328

X ray non progression

(SDC≤2.2; %)

ABA = 257

ADA = 260

Radiographic score, mean

ABA=257

ADA=260

ACR

20

ACR

50

ACR

70

ACR

90

Mean Change*

ABA = 318

ADA = 327

<2.6 (%)**

ABA =251

ADA =244

mTSS

Erosion

JSN

ABA

59.7

44.7

31.1

14.5

-2.35

50.6

54.1

84.8

0.89

0.41

0.48

ADA

60.1

46.6

29.3

8.2

-2.33

53.3

48.8

83.8

1.13

0.41

0.72

*LOCF **As-observed



[1] Weinblatt et al. Arthritis Rheum. January, 2013; 65(1): 28-38


Disclosure:

M. E. Weinblatt,

Bristol-Myers , AbbVie,

2,

Bristol-Myers Squibb, AbbVie,

5,

AbbVie,

9;

M. H. Schiff,

Bristol-Myers Squibb, AbbVie Inc.,

5,

Bristol-Myers Squibb, AbbVie Inc.,

8;

R. Valente,

UCB, Pfizer, Novartis, Eli Lilly, Takeda, Bristol-Myers Squibb, and Centocor,

5;

D. M. van der Heijde,

Abbott, Bristol-Myers Squibb, Amgen, AstraZeneca, Centocor, Chugai, Eli-Lilly, GSK, Merck, Novartis, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB, and Wyeth, ,

5;

G. Citera,

Bristol-Myers Squibb, Pfizer, Abbott,

5,

Pfizer Inc,

2;

A. Elegbe,

Bristol-Myers Squibb,

1,

Bristol-Myers Squibb,

3;

M. A. Maldonado,

Bristol-Myers Squibb,

1,

Bristol-Myers Squibb,

1;

R. Fleischmann,

Bristol-Myers Squibb, AbbVie Inc., Amgen, Pfizer, UCB, Jansen, Roche, Eli-Lilly, Sanofi-Aventis, Novartis, Lexicon, Vertex, and GSK,

5,

Bristol-Myers Squibb and AbbVie Inc.,

2.

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