Results of a two‐year followup study of patients with rheumatoid arthritis who received a combination of abatacept and methotrexate

Abstract

Objective. To evaluate the efficacy, radiographic changes, and safety of abatacept and methotrexate therapy through 2 years in a long-term extension of a previously published 1-year study.Methods. Patients who received placebo during year 1 were switched to abatacept. Patients taking abatacept continued to take it. Efficacy and safety were assessed through 2 years.Results. Of 539 patients enrolled in the initial 1-year study, 488 completed 1 year of the long-term extension (2% discontinued for lack of efficacy). .8% for the HAQ DI, and 9.7 versus 10.6 and 7.3 versus 7.2, respectively, for the mean change in the physical and mental components summary scores of the SF-36). In the abatacept group, post hoc analysis demonstrated further inhibition of radiographic progression during year 2 (57% reduction in mean change of total score in year 2 versus year 1; P < 0.0001), and minimal radiographic progression was observed (mean change in total score from baseline was 1.1 and 1.6 at year 1 and 2, respectively). Rates of adverse events (AEs) and severe AEs were consistent throughout the cumulative period.Conclusion. The improvements in signs and symptoms, physical function, and HRQOL observed after 1 year of abatacept treatment were maintained through 2 years of treatment. This durability was accompanied by a safety profile consistent with that in the double-blind portion of the study. Radiographic proClinicalTrials.gov identifier: NCT00048568.

Patient‐Reported Outcomes From a Two‐Year Head‐to‐Head Comparison of Subcutaneous Abatacept and Adalimumab for Rheumatoid Arthritis

“…As in AMPLE, these 3 abatacept studies included patients with an inadequate response to MTX who were biologics‐naive 5, 24, 25, 26.…”

Abatacept: a T-cell co-stimulation modulator for the treatment of rheumatoid arthritis

“…In other randomized clinical trials, including the AIM (Abatacept in Inadequate responders to Methotrexate) trial, the use of abatacept earlier in the treatment paradigm in patients with an inadequate response to MTX has been evaluated [37,38]. Abatacept demonstrated favorable efficacy in this trial, including inhibition of radiographic progression through 2 years [39], which was not measured in the ATTAIN trial, with an acceptable safety profile.…”

Genetic susceptibility to rheumatoid arthritis: An emerging picture

“…For example, the CTLA4 gene has now been convincingly associated with RA susceptibility, but the increased risk conferred by carrying the associated variant is modest (ϳ15%) (11). Nonetheless, abatacept, a CTLA-4 analog, has been shown to be effective in the treatment of RA patients who have failed to respond to anti-tumor necrosis factor therapy, highlighting the importance of the pathway (38).…”