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AVERT-2 fails to meet primary endpoint, but data advances the field for RA
CHICAGO — Although the AVERT-2 study failed to meet the primary endpoint of a statistically significant difference in SDAI ≤3.3 at 24 weeks, Sheila Kelly, MD, the medical team lead for immunoscience at Bristol-Myers Squibb, sat down with Healio Rheumatology to discuss how the results have nevertheless provided new insight into treatment with abatacept in patients with newly diagnosed ACPA-positive rheumatoid arthritis.
“Some of the key things that we are excited to share here at ACR are the 1-year results of the AVERT-2 study, which is looking at the combination of abatacept plus methotrexate in abatacept- and methotrexate-naïve patients vs. methotrexate alone in a seropositive, high-disease activity patient population,” Kelly told Healio Rheumatology. “In that study in which the primary endpoint was the SDAI remission at 24 weeks, we did not meet the primary endpoint. [However,] we did look at nominal significance of DAS28 (CRP), ACR scores, SDAI remission and radiographic analysis at 52 weeks where there was a nominally significant difference for the abatacept-methotrexate combination vs. methotrexate alone.”
She noted, “This is an area that we have been exploring —the seropositive patient population — and trying to inform clinicians on how they make those decisions for these very active patients that have poor prognostic factors and how should they make those choices when they are faced with very early disease. We think this study is informing the science and how to make those decisions.”