Artikel
Association of radiographic outcomes with low disease activity and remission, and sustainability of response with subcutaneous abatacept or adalimumab: 2-year results from the AMPLE trial
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Veröffentlicht: | 12. September 2014 |
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Gliederung
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Background: Remission and low disease activity (LDA) are now more achievable goals in RA. Data from the AMPLE trial showed comparable rates of remission and LDA for patients treated with subcutaneous (SC) abatacept or adalimumab [1], [2]. We evaluated the relationship of radiographic outcomes with LDA and remission and assessed the sustainability of LDA/remission using 2-year AMPLE data.
Methods: AMPLE is a 2-year, Phase IIIb, randomized, investigator-blinded study. Biologic-naïve RA patients with an inadequate response to MTX were randomized to 125 mg SC abatacept weekly or 40 mg SC adalimumab bi-weekly, with background MTX.1 Proportions of patients achieving remission (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), LDA (CDAI ≤10, SDAI ≤11, RAPID3 ≤6), or with DAS28 (CRP) <2.6 or ≤3.2 were analysed. Radiographic non-progression (change in modified total Sharp score [mTSS] ≤2.2 [smallest detectable change]) was analysed in patients achieving remission at 2 years.
Results: 646 patients were randomized and treated with SC abatacept (n=318) or adalimumab (n=328) on background MTX. Across all criteria, most patients who achieved remission or LDA 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 criteria used. Overall, >85% of patients had radiographic non-progression at Year 2 (Table 1 [Tab. 1]). Patients who achieved remission according to more stringent criteria (SDAI, CDAI, 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.
Conclusion: These data demonstrate that achieving LDA or remission is highly correlated with prevention of radiographic progression (mTSS ≤2.2). Irrespective of criteria used to assess disease activity, ≥65% of patients in both the abatacept and the adalimumab treatment arms achieved a sustained clinical response. Patients who achieved remission according to more stringent criteria were more likely to be radiographic non-progressors than those who achieved LDA.
References
- 1.
- Schiff M, Weinblatt ME, Valente R, van der Heijde D, Citera G, Elegbe A, Maldonado M, Fleischmann R. Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: two-year efficacy and safety findings from AMPLE trial. Ann Rheum Dis. 2014 Jan;73(1):86-94. DOI: 10.1136/annrheumdis-2013-203843
- 2.
- Fleischmann R, et al. Arthritis Rheum. 2013;65(Suppl 10):S209.