Background Remission and low disease activity (LDA) are now more achievable goals in RA. Year 1 and 2 data from the head-to-head AMPLE (Abatacept vs Adalimumab Comparison in Biologic-Naive RA Patients with Background MTX) trial showed comparable rates of remission and LDA for patients (pts) treated with subcutaneous (SC) abatacept (ABA) or adalimumab ADA).1,2
Objectives To evaluate the relationship of radiographic outcomes with achieving LDA and remission and assess the sustainability of LDA/remission using 2-year data from the AMPLE trial.
Methods AMPLE is a 2-year, Phase IIIb, randomized, investigator-blinded study. Biologic-naïve pts with RA and an inadequate response to MTX were randomized to 125 mg SC ABA weekly or 40 mg SC ADA bi-weekly, with background MTX.1 The proportions of pts achieving remission (defined as Clinical Disease Activity Index [CDAI] ≤2.8, Simplified Disease Activity Index [SDAI] ≤3.3, Routine Assessment of Pt Index Data [RAPID]3 <3, Boolean score ≤1), LDA (defined as CDAI ≤10, SDAI ≤11, RAPID3 ≤6), or with Disease Activity Scores [DAS]28 [C-reactive protein; CRP] of <2.6 or ≤3.2 were analysed. Radiographic non-progression (defined as change in modified total Sharp score [mTSS] of ≤2.2 [smallest detectable change]) was analysed in pts achieving remission at 2 years.
Results 646 pts were randomized and treated with SC ABA (n=318) or ADA (n=328) on background MTX. Across all criteria for remission and LDA, most pts who achieved remission, LDA or DAS28 (CRP) scores of <2.6 or ≤3.2 at Year 1 maintained these states through to Year 2 (≥65% and ≥79%, respectively). Similar rates of sustained disease activity were observed in both treatment groups, regardless of the criteria used. Overall, >85% of pts had radiographic non-progression at Year 2 (Table). Pts who achieved remission according to more stringent criteria (SDAI, CDAI, and Boolean) were more likely to be non-progressors than those who achieved LDA or DAS28 (CRP) ≤3.2. The correlation between clinical response and radiographic progression was less evident when non-progression was defined as mTSS ≤0.5 or 0.
Conclusions The data demonstrate that achieving remission, LDA or DAS28 (CRP) scores of <2.6 or ≤3.2 is highly correlated with prevention of radiographic progression (mTSS ≤2.2). Irrespective of the criteria used to assess disease activity, ≥65% of pts in both the SC abatacept and adalimumab treatment arms achieved a sustained clinical response. However, pts who achieved remission according to more stringent criteria were more likely to be radiographic non-progressors than those who achieved LDA or DAS28 (CRP) ≤3.2.
Schiff M, et al. Ann Rheum Dis 2013;73:86-94; 2. Fleischmann R, et al. Arthitis Rheum 2013;65(Suppl 10):S209.
Disclosure of Interest R. Fleischmann Grant/research support: Abbvie, Amgen, Astellas, AstraZeneca, BMS, Celgene, Dynavax, Genzyme, Janssen, Eli Lilly, Merck, Novartis, Pfizer, Roche, Sanofi-Aventis, UCB, Xoma, Consultant for: Abbvie, Amgen, AstraZeneca, BMS, Celgene, Janssen, Eli Lilly, Pfizer, Roche, Sanofi-Aventis, UCB, M. Schiff Consultant for: Bristol-Myers Squibb, Abbvie, Speakers bureau: Bristol-Myers Squibb, Abbvie, M. Weinblatt Grant/research support: BMS, Crescendo Bioscience, UCB, Consultant for: BMS, Crescendo Bioscience, UCB, Abbvie, Roche, Janssen, M. Maldonado Shareholder of: BMS, Employee of: BMS, E. Massarotti Shareholder of: Merck (Under 10,000 US dollars), Grant/research support: Investigator: BMS, Sanofi, Human Genome Sciences, J. Fay Shareholder of: BMS, Employee of: BMS, Y. Yazici Shareholder of: Samumed, Grant/research support: BMS, Genentech, Consultant for: Abbvie, BMS, Genentech, Pfizer, Samumed, UCB