Article
Clinical responses by baseline RA disease duration in the AMPLE (abatacept versus adalimumab comparison in biologic-naïve RA patients with background methotrexate) trial: 2-year results
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Published: | September 12, 2014 |
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Background: Disease duration has a considerable impact on treatment response with DMARDs in RA patients [1]. Those with longer disease duration respond less well to MTX compared with early RA patients. Data that informs decision making, especially early in the disease course, is of significant clinical utility when treating patients with biologic DMARDs. We assessed clinical outcomes in early RA patients (≤6 months’ disease duration) treated with subcutaneous (SC) abatacept or adalimumab compared with patients with >6 months’ disease duration, using 2-year AMPLE data.
Methods: AMPLE is a 2-year, Phase IIIb, randomized, investigator-blinded study. Biologic-naïve patients with RA and inadequate response to MTX were randomized to 125 mg SC abatacept weekly or 40 mg SC adalimumab bi-weekly, with background MTX.[REF1] Baseline disease duration (≤6 and >6 months for each treatment) was analysed in the intention-to-treat population, and the proportions of patients achieving ACR20/50/70 response, remission (defined as Clinical Disease Activity Index [CDAI] ≤2.8, Simplified Disease Activity Index [SDAI] ≤3.3, Boolean score ≤1), low disease activity (LDA; CDAI ≤10, SDAI ≤11) or improvement in physical function (Health Assessment Questionnaire-Disability Index [HAQ-DI] >0.3) were assessed by disease duration and treatment subgroups.
Results: 646 patients were randomized and treated with SC abatacept (n=318) or adalimumab (n=328) on background MTX (71 and 70 patients with ≤6 months’ disease duration; 247 and 258 patients with >6 months’ disease duration). Baseline characteristics were balanced between the disease duration subgroups, with the exception of a higher percentage of males among patients with ≤6 months’ disease duration treated with adalimumab compared with other subgroups. Among patients with ≤6 months’ disease duration, 23.9% (SC abatacept) and 30.0% (adalimumab) of patients discontinued study treatment; 19.8% (SC abatacept) and 24.0% (adalimumab) of patients with >6 months’ disease duration discontinued. Clinical responses by disease duration at Years 1 (AMPLE primary endpoint) and 2 are summarized (Table 1 [Tab. 1]).
Conclusion: Data from this post hoc analysis of the AMPLE trial show that patients treated with effective biologic DMARDs (SC abatacept or adalimumab), whether treated early in the disease course (≤6 months) or later, achieved comparable responses across a range of clinical measures.
References
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- Anderson JJ, Wells G, Verhoeven AC, Felson DT. Factors predicting response to treatment in rheumatoid arthritis: the importance of disease duration. Arthritis Rheum. 2000 Jan;43(1):22-9.