The biologic agent abatacept (Orencia) can now be prescribed, together with methotrexate, for the treatment of highly active and progressive rheumatoid arthritis (RA) in patients who have not received prior treatment with methotrexate.
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Summary of Product Characteristics
Manufacturer: BMSOrencia is also licensed for use with methotrexate for the treatment of moderate to severe active RA in adults who are unresponsive to other DMARDs, including methotrexate or a TNF inhibitor. The recommended dose is the same for both indications.
Rates of remission
The efficacy of abatacept in terms of induction of remission after 12 months of treatment and maintenance of drug-free remission after complete drug withdrawal was compared with that of abatacept plus methotrexate and methotrexate alone in a study involving 351 methotrexate-naive adults with highly active early RA and poor prognostic factors for rapidly progressive disease.
After 12 months of treatment, a significantly greater proportion of patients in the combination group achieved Disease Activity Score 28 remission (DAS28-CRP <2.6) than in the methotrexate monotherapy group (60.9% vs 45.2%, p=0.010). The rate of DAS28-CRP remission after 12 months of abatacept monotherapy was similar to that of methotrexate monotherapy, at 42.5%.
In addition, a greater proportion of patients achieved Simplified Disease Activity Index clinical remission (SDAI ≤3.3) and Boolean clinical remission in the combination group than in the methotrexate monotherapy group.
Among the patients who achieved a DAS28-CRP score less than 3.2 at 12 months and underwent complete drug withdrawal, the proportion who were in DAS-defined remission at both 12 and 18 months was significantly higher for those who had been treated with abatacept plus methotrexate than for those who had received methotrexate alone (14.8% vs 7.8%; OR 2.51, 95% CI 1.02-6.18; p=0.045).
Patients receiving abatacept plus methotrexate were also found to have less progression in structural joint damage as assessed by MRI (erosion, osteitis and synovitis scores) than those receiving methotrexate monotherapy. Similarly, the proportion of patients in the combination group with a clinically meaningful improvement in physical function (assessed using the Health Assessment Questionnaire Disability Index [HAQ-DI]) was greater than in the methotrexate group.
The three treatment groups were similar in terms of safety profile.