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ORENCIA delivered increased ACR
responses
in MTX inadequate responders and maintained them through 2 years
- Primary endpoints were ACR 20 at 6 months ORENCIA vs placebo
(67.9% vs 39.7%, respectively; P<0.001), clinically significant improvement in HAQ-DI
at 1 year (63.7% vs 39.3%, respectively; P<0.001) and erosion score at 1 year
– ORENCIA delivered a mean improvement from baseline of approximately 80% in both tender and swollen joint counts in MTX inadequate responders at 2 years
- 56.1% (185/330) of patients treated with ORENCIA also achieved a DAS ≤3.2 and 30.9% (102/330) achieved a DAS >2.6 at 2 years (view this data)
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Learn more about AIM.
Data are based on an as-observed analysis performed on data available at the visit of interest without imputation, ie, observed cases. At 2 years, only patients originally randomized to ORENCIA are represented.
Phase III, multicenter, randomized, double-blind, placebo-controlled trial with 652 patients treated at baseline who had active RA despite MTX therapy (638 included in efficacy analyses). Double-blind through 1 year, followed by an ongoing, open label, long-term extension study. A total of 376 (from the original 424) patients in the group treated with ORENCIA entered the long-term extension study. Additional DMARDs were added and/or adjusted at the discretion of the investigator in the long-term extension study. Primary reasons for discontinuation in the long-term extension study were adverse events, withdrawal of consent, and lack of efficacy.
In 5 clinical trials, the most serious adverse reactions were serious infections (3% ORENCIA vs 1.9% placebo) and malignancies
(1.3% ORENCIA vs 1.1% placebo). The most commonly reported acute infusion-related AEs (1%-2%) were dizziness, headache, and hypertension with fewer than 1% of patients discontinuing ORENCIA due to infusion-related events. For additional information see Safety
ORENCIA provided durable ACR 70 response rates through 4 years in MTX inadequate responders
- Primary endpoint was ACR 20 at 6 months ORENCIA vs placebo (60.0% vs 35.3%, respectively; P<0.001)
- ORENCIA also provided an ACR 20 in 71.2% (42/59) of patients and an ACR 50 in 40.7% (24/59) of patients at Year 4
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Learn more about Phase IIb (Study 101-100)
Data are based on an as-observed analysis performed on data available on the visit of interest without imputation, i.e. observed cases, including the patients randomized to the ORENCIA group only.
Phase IIb, multicenter, randomized, double-blind, placebo-controlled trial with 339 randomized patients with active RA despite MTX therapy (115 patients received ORENCIA [abatacept] at a fixed dose approximating 10 mg/kg). Double-blind through 1 year, followed by an open-label, long-term extension study. A total of 84 (from the original 115) patients in the group treated with ORENCIA entered the long-term extension study. Additional DMARDs, NSAIDs, and aspirin were added and/or adjusted at the discretion of the investigator in the long-term extension study. Primary reasons for discontinuation in the long-term extension study were adverse events and lack of efficacy.
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