Two-Year Results From The Ample Trial: Low Disease Activity and Association Between Remission and Changes In Physical Function and Radiographic Outcomes With Subcutaneous Abatacept Or Adalimumab

Roy Fleischmann¹, M Schiff², M E Weinblatt³, M Maldonado⁴, E Massarotti⁵ and Y Yazici⁶, ¹University of Texas Southwestern Medical Center, Dallas, TX, ²University of Colorado, Denver, CO, ³Brigham & Women's Hospital, Boston, MA, ⁴Bristol-Myers Squibb, Princeton, NJ, ⁵Brigham and Women's Hospital, Boston, MA, ⁶New York University Hospital for Joint Diseases, New York, NY

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: Abatacept, adalimumab and rheumatoid arthritis (RA)

Session Information

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

Session Type: Abstract Submissions (ACR)

Background/Purpose: Remission and low disease activity (LDA) are now more achievable goals in RA. Year 1 data from the head-to-head AMPLE (Abatacept vs Adalimumab Comparison in Biologic-Naive RA Patients with Background MTX) study showed comparable rates of remission and LDA for patients treated with subcutaneous (SC) abatacept or adalimumab.¹ To assess whether these responses are maintained over time and to evaluate the relationship with functional and radiographic outcomes, we report Year 2 data from AMPLE. Methods: AMPLE is a 2-year, Phase IIIb, randomized, investigator-blinded study. Biologic-naïve patients with RA and an inadequate response to MTX were randomized to 125 mg SC abatacept weekly or 40 mg SC adalimumab bi-weekly, with background MTX.¹ The proportions of patients achieving remission (defined as Disease Activity Score [DAS]28 [C-reactive protein; CRP] <2.6, Clinical Disease Activity Index [CDAI] ≤2.8, Simplified Disease Activity Index [SDAI] ≤3.3, Routine Assessment of Patient Index Data [RAPID]3 <3, Boolean score ≤1) or LDA (defined as DAS28 [CRP] ≤3.2, CDAI ≤10, SDAI ≤11, RAPID3 ≤6) are presented. Physical function (assessed with the Health Assessment Questionnaire-Disability Index [HAQ-D]I; responders defined as an improvement of ≥0.3) and radiographic non-progression (defined as change in modified total Sharp score of ≤ smallest detectable change) were analyzed in patients achieving remission at 2 years. Results: A total of 646 patients were randomized and treated with abatacept (n=318) or adalimumab (n=328) on background MTX. Baseline clinical characteristics were balanced between treatments. The proportions of patients in remission or LDA at Year 2 were comparable for both treatments (Table), and were higher than those reported at Year 1.^1,2 More patients achieved DAS28 (CRP) remission compared with CDAI, SDAI, and RAPID3 remission, with the smallest proportion achieving Boolean remission. Depending on the criteria used to assess remission, 65.9–80.2% of adalimumab-treated patients and 72.7–81.2% of abatacept-treated patients who were in remission at Year 1 were maintained in a state of remission at Year 2. Across all criteria, >70% of patients in remission at Year 2 were also HAQ-DI responders, and >85% were radiographic non-progressors at Year 2. Improvement in physical function and radiographic outcomes at Year 2 were consistent between the two treatments.

	SC abatacept + MTX n/N (%)	SC adalimumab + MTX n/N (%)
Remission criteria
DAS28 (CRP) <2.6	127/251 (50.6)	130/244 (53.3)
CDAI ≤2.8	80/250 (32.0)	74/244 (30.3)
SDAI ≤3.3	78/250 (31.2)	79/243 (32.5)
RAPID3 (0–30) ≤3	77/248 (31.0)	61/233 (26.2)
Boolean	52/251 (20.7)	50/244 (20.5)
Low disease activity criteria
DAS28 (CRP) ≤3.2	164/251 (65.3)	166/244 (68.0)
CDAI ≤10	164/250 (65.6)	165/244 (67.6)
SDAI ≤11	163/250 (65.2)	168/243 (69.1)
RAPID3 (0–30) ≤6	123/248 (49.6)	116/233 (49.8)

Conclusion: Over 2 years of the AMPLE study, rates of remission and LDA increased over time across all criteria and remained comparable for SC abatacept and adalimumab. All remission criteria demonstrated high correlation with physical function and radiographic outcomes, with similar improvements in each treatment group at Year 2. References: 1. Weinblatt M, et al. Arthritis Rheum 2013;65:28–38. 2. Fleischmann R, et al. Ann Rheum Dis 2013;72(Suppl. 3):626.

Disclosure:

R. Fleischmann,

Bristol-Myers Squibb, Abbvie,

M. Schiff,

Bristol-Myers Squibb, Abbvie,

M. E. Weinblatt,

Bristol-Myers Squibb,

Bristol-Myers Squibb, Roche/Genentech, UCB, Janseen,

M. Maldonado,

Bristol-Myers Squibb,

E. Massarotti,

Bristol-Myers Squibb,

UCB,

Y. Yazici,

Abbvie, Bristol-Myers Squibb, Celgene, Genentech, UCB ,

Bristol-Myers Squibb, Genentech ,

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