U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years...( In Period B of the study patients who...),Health
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In Period B of the study, patients who completed Period A and achieved an ACR Pedi 30 response were eligible to enter this six-month, double-blind phase. Patients entering Period B (n=122) were randomized to remain on ORENCIA (n=60) or receive placebo (n=62) for six months.
The primary endpoint of the study was time to occurrence of disease
flare. Disease flare was defined as a greater than or equal to 30 percent
worsening in at least three of the six JIA core set variables with greater
than or equal to 30 percent improvement in not more than one of the six JIA
core set variables; greater than or equal to two centimeters of worsening
of the Physician or Parent Global Assessment was necessary if used as one
of the three JIA core set variables used to define flare, and worsening in
greater than or equal to two joints was necessary if the number of active
joints or joints with limitation of motion was used as one of the three JIA
core set variables used to define flare.
Efficacy results included:
-- Time difference to occurrence of disease flare was statistically
significant based on the log-rank test in patients treated with
placebo compared with ORENCIA(R) (abatacept)
(p-value equals 0.0002).
-- Patients treated with ORENCIA experienced significantly fewer disease
flares compared to placebo-treated patients (20 percent vs. 53
percent, respectively, p-value less than 0.001).
-- The risk of disease flare among patients continuing on ORENCIA was
less than one-third than that for patients who withdrew from ORENCIA
treatment [Hazard Ratio: 0.31, 95 percent CI (0.16, 0.59)].
In patients receiving ORENCIA treatment throughout the study (Period A, Period B and the open-label extension Period C), the proportion of ACR Pedi 30, 50 and 70 responders remained consistent through one year.
In both the open-label, lead-in (Period A) and double-blind (Pe
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| SOURCE Bristol-Myers Squibb Company Copyright©2008 PR Newswire. All rights reserved |
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