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Sustained disease remission and inhibition of radiographic progression in methotrexate-naive patients with rheumatoid arthritis and poor prognostic factors treated with abatacept: 2-year outcomes
Annals of Rheumatic Diseases, 08/23/2011
Clinical Article
Bathon J et al. – The AGREE trial was the first to examine the impact of T-cell co-stimulation modulation with abatacept in patients with early erosive RA. Early treatment with abatacept+methotrexate resulted in greater sustainable clinical, functional and radiographic benefits than methotrexate alone, with acceptable safety and tolerability.
Methods- AGREE was 2-year phase IIIb multinational study in early (≤2 years) RA
- During double-blind period (year 1), patients were randomly assigned 1:1 to receive abatacept+methotrexate or methotrexate alone; all patients received open-label abatacept+methotrexate during year 2
- Clinical outcomes assessed included 28-joint disease activity score (DAS28) defined remission, low disease activity score (LDAS), American College of Rheumatology (ACR) responses and physical function
- Radiographic outcomes assessed using Genant-modified Sharp total score (TS)
- Safety was monitored throughout
- Of the 459 patients completing year 1, 433 patients (94.3%) completed year 2
- DAS28-defined remission, LDAS, ACR and physical function were sustained through year 2 in the original abatacept+methotrexate group, with 55.2% in remission at 2 years
- Upon introduction of abatacept in methotrexate-alone group, additional patients achieved DAS28-defined remission (44.5% vs 26.9%), LDAS (60.4% vs 43.2%) and improved ACR 70 (49.8% vs 31.7%) for year 2 versus year 1
- Less radiographic progression was observed at 2 years in original abatacept+methotrexate group than methotrexate-alone group (change in TS 0.84 vs 1.75, p<0.001)
- No new safety issues were seen
- Similar rates of serious adverse events, serious infections and autoimmune events observed in years 1 and 2