Session Title: Plenary Session III: Discovery 2012
Session Type: Plenary Sessions
Background/Purpose : The availability of multiple biologic agents to treat rheumatoid arthritis (RA) has created a need for comparative assessment. AMPLE (Abatacept Versus Adalimumab Comparison in Biologic-Naive RA Subjects with Background Methotrexate) is the first head-to-head study powered to compare SC abatacept (ABA) and adalimumab (ADA) on a background of methotrexate (MTX). Here, we report key 1 year data from AMPLE including ACR core component data.
Methods: AMPLE is an ongoing, phase IIIb, randomized, investigator-blinded study of 24 months duration with a 12 month primary efficacy endpoint. Biologic-naïve RA patients with an inadequate response to MTX were randomized to 125 mg ABA weekly or 40 mg ADA bi-weekly, in combination with MTX. The primary end point was non-inferiority (NI) of ABA to ADA based on ACR 20 at 12 months; key secondary endpoints were rates of radiographic non-progression, safety, injection site reactions and retention. ACR core component data were also analyzed.
Results: A total of 646 patients were randomized and treated; 86.2% of ABA patients and 82.0% of ADA patients completed 12 months. Baseline characteristics were balanced across both arms (mean DAS28-CRP of 5.5 and disease duration ~1.8 yrs). At 1 year, 64.8% of ABA patients and 63.4% of ADA patients achieved an ACR 20 response, with an estimated difference between the two arms (95% CI) of 1.8 (-5.6, 9.2) supporting NI of ABA to ADA. The kinetics of response across ACR scores were comparable overall, with an ACR50 of 46.2% and 46% and ACR70 of 29.2% and 26.2% for ABA and ADA, respectively, at 1 year. Similar responses over time were seen in some ACR core components (Figure). At 1 year, the rates of radiographic non-progression were comparable, as were mean changes in van der Heijde-modified total Sharp scores (0.58 vs. 0.38, for ABA vs. ADA respectively). The rates of AEs, SAEs, serious infections and malignancies were comparable. There were more patients with autoimmune AEs (3.1% vs. 0.9%) in the ABA arm; however, none were serious. One patient discontinued in each arm due to an autoimmune event. There were fewer discontinuations with ABA due to AEs (3.5% vs. 6.1%) and due to serious infections (0% vs. 1.5%). Injection site reactions occurred in significantly fewer ABA-treated patients (3.8% vs. 9.1% [p=0.006]).
Conclusion: This first head-to-head study in RA patients comparing biologic agents on background MTX demonstrated that subcutaneous abatacept is comparable to adalimumab by most efficacy measures, including radiographic progression. Safety was generally similar with fewer discontinuations and injection site reactions observed with abatacept.
M. E. Weinblatt,
Bristol-Myers Squibb, Abbott,
Bristol-Myers Squibb, Abbott,
M. H. Schiff,
Genentech Inc,, Roche, Abbott, Amgen, UCB, Pfizer, BMS, Lilly, Sanofi Aventis, Lexicon, MSD, Novartis, BiogenIdec, Astellas, Astra-Zeneca, Jansen,
Roche, Abbott, Amgen, UCB, Pfizer, BMS, Lilly, Sanofi Aventis, Lexicon, Novartis, Astellas, Astra-Zeneca, Jansen, HGS,
UCB,Pfizer,Novartis,Eli Lilly,Takeda, Centocor,
D. van der Heijde,
Abbott, Amgen, AstraZeneca, BMS, Centocor, Chugai, Eli-Lilly, GSK, Merck, Novartis, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB, Wyeth,
Owner of Imaging Rheumatology bv,
Pfizer, Bristol-Myers Squib, Astra Zeneca,
M. A. Maldonado,
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/head-to-head-comparison-of-subcutaneous-abatacept-versus-adalimumab-in-the-treatment-of-rheumatoid-arthritis-key-efficacy-and-safety-results-from-the-ample-abatacept-versus-adalimumab-comparison-in/