ORENCIA improved Disease Activity Scores (DAS28 <3.2
and DAS28 <2.6) in TNF inadequate responders through 2 years

• Primary endpoints were ACR 20 at 6 months ORENCIA vs placebo
  (50.4% vs 19.5%, respectively; P<0.001) and improvement in HAQ-DI at 6 months (47.3% vs 23.3%, respectively; P<0.001)

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Data are based on an as-observed analysis performed on data available at the visit of interest without imputation, ie, observed cases, including patients randomized to the ORENCIA group only.

Phase III, multicenter, randomized, double-blind, placebo-controlled trial with 391 patients treated at baseline who had active RA despite anti-TNF therapy (389 included in efficacy analyses). Double-blind through 6 months, followed by an ongoing, open-label, long-term extension study. A total of 217 (from the original 256) 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.

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 link below.

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