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ORENCIA improved ACR response rates in anti-TNF inadequate responders and sustained them 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)
- ORENCIA demonstrated a mean improvement
of approximately 67% from baseline in both tender and swollen joint counts in anti-TNF inadequate responders at 2 years
Learn more about ATTAIN
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, doubleblind, 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 218 (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
ORENCIA produced clinically meaningful ACR response rates regardless of previous anti-TNF therapy at 6 months
‡Etanercept or infliximab were received independently. Patients could have previously had an inadequate response to etanercept and subsequently to infliximab or vice versa.
- Patients with either loss of response to previous anti-TNF therapy or no response to previous anti-TNF therapy were included in this analysis
Less than 1% of patients treated with ORENCIA experienced hypersensitivity reactions, including two cases of anaphylaxis or anaphylactoid reactions. Other events potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea, each occurred in less than 0.9% of patients treated with ORENCIA and generally occurred within 24 hours of an infusion with ORENCIA. Appropriate medical support measures for the treatment of hypersensitivity reactions should be available for immediate use in the event of a reaction.
During the double-blind period, an intent-to-treat analysis was used which included all patients randomized. Those who were lost to follow-up were considered as nonresponders to treatment.
NEXT: HAQ-DI scores in Anti-TNF Inadequate Responders
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