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New Head-to-Head Outcomes Data for Orencia SC (Abatacept) vs. Humira (Adalimumab) in Rheumatoid Arthritis
New clinical trial results have shown that the subcutaneous (SC) formulation of Orencia (abatacept, Bristol-Myers Squibb) on a background of methotrexate (MTX) was similar to Humira (adalimumab, Abbott) plus MTX in demonstrating clinical improvements in patient-reported outcomes (PROs) in adults with moderate to severe rheumatoid arthritis (RA), including patient pain, patient global assessment, fatigue, physical function, and health-related quality of life (HRQoL).
At 1 year, Orencia SC plus MTX was similar to Humira plus MTX in improving patient pain (53.0% vs. 39.2%, respectively), in improving patient global assessment (46.1% vs. 41.2%), and in reducing fatigue (–23.2% and –21.4%). Normal physical function, as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI), was achieved by 60.4% of the Orencia SC group and by 57.0% of the Humira group. HRQoL, assessed using the SF-36, was also similar between the two groups.
The new data come from an analysis of 1-year results in the phase IIIb AMPLE (Abatacept Versus AdaliMumab ComParison in BioLogic-NaivE RA Subjects With Background Methotrexate) trial — an ongoing investigator-blinded, randomized, controlled study. A total of 646 adult, biologic-naïve patients with moderate to severe RA were randomly assigned to receive either Orencia SC 125 mg weekly without an intravenous (IV) load (n = 318) or Humira 40 mg every other week (n = 328), both on background MTX. The primary efficacy goal was to determine the noninferiority of Orencia SC plus MTX to Humira plus MTX by a difference in the ACR20 response at 12 months. Secondary endpoints included injection-site reactions, radiographic nonprogression, safety, and retention.
Improvements in all PROs measured in the study were seen at 6 months and were sustained at 1 year. Improvements in patient pain (mean percent) at 1 year were 53.0% in the Orencia SC treatment group and 39.2% in the Humira group (estimate of difference: 13.8%). Improvements were also demonstrated in the patient global assessment at 1 year (46.1% with Orencia SC plus MTX and 41.2% with Humira plus MTX; estimate of difference: 4.89%).
In addition, at 1 year the proportion of patients achieving an HAQ-DI response indicating normal physical function was similar between the two treatment groups. The mean HAQ-DI scores at baseline were 1.49 in the Orencia SC group and 1.45 in the Humira group. The mean changes from baseline to year 1 in HAQ-DI were –0.60 and –0.59 for Orencia SC and Humira, respectively. Similar reductions in fatigue observed at 6 months were maintained through year 1 in both the Orencia SC and Humira groups. These reductions exceeded the minimal clinically important difference (MCID) (i.e., a change of –10 mm), with an estimated mean difference of –2.42.
Orencia (SC and IV) is indicated for reducing signs and symptoms, inducing a major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. Orencia SC may be used as monotherapy or concomitantly with disease-modifying antirheumatic drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists.
Orencia IV is indicated for reducing signs and symptoms in pediatric patients 6 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis. Orencia IV may be used as monotherapy or concomitantly with methotrexate (MTX). Orencia SC has not been studied in pediatric patients. Orencia should not be administered concomitantly with TNF antagonists, and it is not recommended for use concomitantly with other biologic RA drugs, such as anakinra (Kineret, Amgen).
Source: Bristol-Myers Squibb; November 12, 2012.