MBDA (multi-biomarker disease activity) scores to evaluate disease activity in rheumatoid arthritis patients with abatacept or adalimumab treatment
Rheumatoid arthritis is one of the most prevalent autoimmune arthritis causing pain and inflammation in many joints like in the hands and feet. In this study, the AMPLE (Abatacept versus adaliMumab comParison in bioLogic-naïvE RA subjects with background methotrexate) trial is highlighted to depict the clinical measures of disease activity in patients via the multi-biomarker disease activity score.
In the AMPLE (NCT00929864) trial, the rheumatoid arthritis patients who were not previously exposed to biological agents and had inadequate response to methotrexate were randomized (1:1) to subcutaneous (SC) abatacept (125 mg weekly) or SC adalimumab (40 mg every 2 weeks), with background methotrexate, for 2 years. The serum samples were collected at baseline, 3 months and 1 and 2 years to examine the MBDA score. For abatacept and adalimumab treatment groups, the comparison was made with adjusted mean change from baseline in MBDA score. To distinguish the MBDA score and clinical measures of disease activity, cross-tabulation was used which comprised: Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), 28-joint Disease Activity Score (DAS28 C-reactive protein [CRP]) and Routine Assessment of Patient Index Data (RAPID)-3.
A total of 318 and 328 patients were randomized to abatacept and adalimumab for which the MBDA data was accessible for 259 and 265 patients. No alliance was found between MBDA score and disease activity described by SDAI, CDAI, DAS28 (CRP), or RAPID-3 in the abatacept and adalimumab treatment groups.
In RA patients who receive abatacept or adalimimab as a cardinal biologic therapy, the MBDA score did not reflect clinical disease activity in patients enrolled in AMPLE and should not be used to escort decision-making in its management.