Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: Advancements in the understanding of Rheumatoid Arthritis (RA) have led to the development of novel therapeutics and treatment guidelines that target remission as an achievable goal in RA. Further, this has created a debate on the definition and dimensions of remission in RA. We report here, the impact of treatment with subcutaneous abatacept (ABA) or adalimumab (ADA) on remission in the AMPLE (Abatacept Versus Adalimumab Comparison in Biologic Naive RA Subjects with Background Methotrexate) study, the first head-to-head trial in RA patients with inadequate response to methotrexate (MTX). AMPLE provides a novel opportunity to compare biologic agents with different mechanisms of action and their ability to achieve remission defined by multiple criteria.
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 a stable dose of MTX. The proportions of patients achieving remission defined as DAS28-CRP <2.6, SDAI ≤3.3, CDAI ≤2.8, RAPID3 <1, and Boolean score ≤1 were assessed. Patient function (assessed with the health assessment questionnaire disability index [HAQ-DI - responders defined as reduction ≥ 0.3]) and radiographic non-progression (defined as change in modified total Sharp score of ≤ 0.5 or ≤ 2.8, change in erosion or joint space narrowing score of ≤ 0.5) were then analyzed in patients achieving remission at 1 year.
Results: The baseline clinical characteristics of ABA (n = 318) and ADA (n = 328) treatment groups were balanced, as was clinical, functional and radiographic efficacy and safety at 1 year with minor differences. The proportions of patients meeting each of the remission criteria at 1 year were generally equal for both groups, but significantly more patients achieved DAS28-CRP remission compared to CDAI, SDAI or RAPID3 remission, and the smallest proportion achieved Boolean remission (Table). Across all assessed remission criteria, 76-85% of patients in both treatment arms were HAQ responders at year 1. Furthermore, 63-100% of patients were radiographic non-progressors depending on the remission criteria employed; however, similar radiographic outcomes were seen in both treatment arms.
Conclusion: Patients treated with SC abatacept or adalimumab in the AMPLE trial achieved comparable rates of remission as assessed across multiple criteria. Similar improvements in physical function and radiographic outcomes were observed in patients that achieved remission. Data reported here further highlight the difference in remission rates depending on the measure used and help illustrate the relationship between remission and functional and radiographic outcomes independent of choice of effective treatment in RA.
|
Remission Criteria |
SC Abatacept |
Adalimumab |
|
DAS28-CRP ≤ 2.6, n/m (%) |
119/275 (43.3%) |
112/267 (41.9%) |
|
RAPID3 = 0-1.0 |
74/272 (27.2%) |
66/263 (25.1%) |
|
CDAI ≤ 2.8 |
65/277 (23.5%) |
64/267 (24.0%) |
|
SDAI ≤ 3.3 |
64/275 (23.3%) |
66/266 (24.8%) |
|
Boolean |
6/275 (2.2%) |
15/267 (5.6%) |
Disclosure:
R. Fleischmann,
Genentech Inc,, Roche, Abbott, Amgen, UCB, Pfizer, BMS, Lilly, Sanofi Aventis, Lexicon, MSD, Novartis, BiogenIdec, Astellas, Astra-Zeneca, Jansen,
2,
Roche, Abbott, Amgen, UCB, Pfizer, BMS, Lilly, Sanofi Aventis, Lexicon, Novartis, Astellas, Astra-Zeneca, Jansen, HGS,
5;
M. H. Schiff,
Bristol-Myers Squibb,
5,
Abbott Laboratories,
8;
M. E. Weinblatt,
Bristol-Myers Squibb, Abbott,
2,
Bristol-Myers Squibb, Abbott,
5;
M. A. Maldonado,
Bristol-Myers Squibb,
3,
Bristol-Myers Squibb,
1;
E. M. Massarotti,
Bristol-Myers Squibb,
2,
UCB,
5;
Y. Yazici,
Bristol-Myers Squibb, Genentech, Celgene, Jannsen,
2,
Bristol-Myers Squibb, Abbott, Genentech, UCB, Pfizer, Merck,
5,
Bristol-Myers Squibb, Abbott,
8.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/effects-of-subcutaneous-abatacept-or-adalimumab-on-remission-and-associated-changes-in-physical-function-and-radiographic-outcomes-one-year-results-from-the-ample-abatacept-versus-adalimumab-compari/