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document
Etanercept plus standard therapy for Wegener 's granulomatosis . BACKGROUND The majority of patients with Wegener 's granulomatosis have disease flares after conventional medications are tapered . There is no consistently safe , effective treatment for the maintenance of remission . METHODS We conducted a randomized , placebo-controlled trial at eight centers to evaluate etanercept for the maintenance of remission in 180 patients with Wegener 's granulomatosis . The primary outcome was sustained remission , defined as a Birmingham Vasculitis Activity Score for Wegener 's Granulomatosis of 0 for at least six months ( scores can range from 0 to 67 , with higher scores indicating more active disease ) . In addition to etanercept or placebo , patients received standard therapy ( glucocorticoids plus cyclophosphamide or methotrexate ) . After remission , standard medications were tapered according to the protocol . RESULTS The mean follow-up for the overall cohort was 27 months . Of the 174 patients who could be evaluated , 126 ( 72.4 percent ) had a sustained remission , but only 86 ( 49.4 percent ) remained in remission for the remainder of the trial . There were no significant differences between the etanercept and control groups in the rates of sustained remission ( 69.7 percent vs. 75.3 percent , P=0.39 ) , sustained periods of low-level disease activity ( 86.5 percent vs. 90.6 percent , P=0.32 ) , or the time required to achieve those measures . Disease flares were common in both groups , with 118 flares in the etanercept group ( 23 severe and 95 limited ) and 134 in the control group ( 25 severe and 109 limited ) . There was no significant difference between the etanercept and control groups in the relative risk of disease flares per 100 person-years of follow-up ( 0.89 , P=0.54 ) . During the study , 56.2 percent of patients in the etanercept group and 57.1 percent of those in the control group had at least one severe or life-threatening adverse event or died ( P=0.90 ) . Solid cancers developed in six patients in the etanercept group , as compared with none in the control group ( P=0.01 ) . CONCLUSIONS Etanercept is not effective for the maintenance of remission in patients with Wegener 's granulomatosis . Durable remissions were achieved in only a minority of the patients , and there was a high rate of treatment-related complications .
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Intervention_Pharmacological
Etanercept plus standard therapy
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
etanercept
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Intervention_Pharmacological
etanercept
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Intervention_Control
placebo
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Intervention_Pharmacological
standard therapy ( glucocorticoids plus cyclophosphamide or methotrexate ) .
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Intervention_Pharmacological
standard medications
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Intervention_Pharmacological
etanercept
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Intervention_Pharmacological
etanercept
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Intervention_Control
control group
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Intervention_Pharmacological
etanercept
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Intervention_Pharmacological
etanercept
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Intervention_Pharmacological
etanercept
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Intervention_Pharmacological
Etanercept
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Outcome_Other
sustained remission
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Outcome_Other
sustained remission
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Outcome_Physical
remission
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Outcome_Physical
rates of sustained remission
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Outcome_Physical
low-level disease activity
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Outcome_Physical
Disease flares
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Outcome_Physical
relative risk of disease flares
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Outcome_Adverse-effects
severe or life-threatening adverse event
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Outcome_Mortality
died
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Outcome_Physical
Solid cancers
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Outcome_Physical
maintenance of remission
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Outcome_Physical
Durable remissions