July 27, 2016
Data from the recent AMPLE (Abatacept versus Adalimumab Comparison in Biologic-Naïve RA Subjects with Background Methotrexate (MTX)) trial showed improvements in patient-reported outcomes (PROs) when treated with abatacept or adalimumab.
Researchers reported their findings of the phase IIIb, randomized, investigator-blinded trial reporting 2-year PROs, in Arthritis Care & Research.
Biologic-naïve patients with rheumatoid arthritis (RA) and an inadequate response to MTX, but with a background MTX, were randomized to subcutaneous (SC) abatacept or adalimumab (125 mg/week or 40 mg every 2 weeks). Researchers focused on four PROs in patients including, pain, fatigue, ability to work, and ability to perform daily activities. The PROs were compared up to year 2 for patients in each treatment group along with those who achieved low disease activity in years 1 and 2 (responders), and those who did not (nonresponders).
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Of the 646 patients who were randomized and treated with SC abatacept (n = 318) or adalimumab (n = 328), baseline characteristics were balanced between the two treatments. Both groups experienced improvements in PROs from baseline over 2 years. Specifically, pain improved in the abatacept group by 53.7% ± 6.2% compared with an improvement of 38.5% ± 6.1% in the adalimumab group (mean treatment difference = 15.2%). Furthermore, at year two, fatigue improved on a 100-mm visual analog scale by 23.4 mm and 21.5 mm with abatacept and adalimumab, respectively.
Patients in both groups showed a minimal clinically important difference (MCID) of 7% for 6-months, 1-year, and 2-years follow-up in both groups. Improvements of up to four additional days of daily living were also seen at all follow-up visits.
The clinical nonresponders did not achieve as great of an improvement in PROs when compared to the responders.
The AMPLE trial was supported by Bristol-Myers Squibb. -Julie Gould
Fleischmann R, Weinblatt ME, Schiff M, et al. Patient-Reported Outcomes From a Two-Year Head-to-Head Comparison of Subcutaneous Abatacept and Adalimumab for Rheumatoid Arthritis [published online ahead of print June 23, 2016]. Arthritis Care Res. 2016;68(7):907-913. doi: 10.1002/acr.22763.