Bristol-Myers Squibb Company announced results of several new sub-analyses of the Phase 3b AVERT (Assessing Very Early Rheumatoid arthritis Treatment) trial investigating the use of Orencia (abatacept) plus methotrexate (MTX) in biologic and MTX-naïve citrullinated protein (CCP)-positive early moderate to severe rheumatoid arthritis (RA) patients.
The AVERT trial included 351 adult patients with symptoms of moderate to severe RA for less than two years, positive for anti-CCP antibodies, DAS28 CRP >3.2 and naïve to treatment with methotrexate and biologic therapies for RA. Patients were randomized to 12 months of weekly treatment with Orencia plus MTX, Orencia alone, or MTX alone.
The analysis assessing the development of anti-CCP antibodies in patients with early rapidly progressing RA demonstrated that Orencia plus MTX numerically reduced the concentrations of all CCP isotypes and the average number of epitopes recognized over one year of treatment more than Orencia alone or MTX alone. Significantly more patients on Orencia plus MTX achieved the clinical endpoint of Boolean-defined remission at 12 months (37% Orencia plus MTX; 26.7% Orencia alone; 22.4% MTX alone; P<0.05). Higher remission rates as compared to MTX or Orencia alone were consistent across other clinical measures, including CDAI remission (42% Orencia plus MTX; 31% Orencia alone; 27.6% MTX alone; P<0.05) and SDAI remission (42% Orencia plus MTX; 29.3% Orencia alone; 25% MTX alone; P<0.05). A significantly higher number of patients treated with Orencia plus MTX were able to maintain drug-free remission up to month 18 and six months after drug withdrawal, according to the remission threshold of DAS28-CRP <2.4 (13% Orencia plus MTX; vs. 3.5% MTX alone; P=0.002).
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Sustained improvements on MRI endpoints were also observed at six months after stopping combination therapy with Orencia plus MTX vs. MTX alone, including improved measurements of both joint inflammation and joint erosion. At 18 months of this post-hoc analysis, the adjusted mean change from baseline in total synovitis score was -1.34 for Orencia plus MTX vs. -0.49 for MTX alone; -2.03 for Orencia plus MTX vs. 0.34 for MTX alone in total osteitis score; and 0.13 for Orencia plus MTX vs. 2.00 for MTX alone in total erosion score (P<0.05 for all three measures).
Orencia is already indicated to reduce signs/symptoms, induce major clinical response, inhibit progression of structural damage, and improve physical function in patients with moderately-to-severely active rheumatoid arthritis; may be used alone or with DMARDS other than TNF antagonists. It is also approved to reduce signs/symptoms of moderately-to-severely active polyarticular juvenile idiopathic arthritis in patients ≥6 years of age; may be used alone or with methotrexate.
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