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document
CDP571 , a humanized monoclonal antibody to tumour necrosis factor-alpha , for steroid-dependent Crohn 's disease : a randomized , double-blind , placebo-controlled trial . BACKGROUND More than 50 % of patients with Crohn 's disease become either steroid resistant or dependent . Accordingly , development of new treatments for steroid-dependent Crohn 's disease is a research priority . AIM To evaluate CDP571 , a humanized antibody to tumour necrosis factor-alpha , for the treatment of steroid-dependent Crohn 's disease . METHODS Patients with steroid-dependent Crohn 's disease ( n = 271 ) were enrolled in a 36-week , double-blind , placebo-controlled trial . Steroid dependence was defined as use of prednisolone or prednisone ( 15-40 mg/day ) or budesonide ( 9 mg/day ) for > or =8 weeks , a previous failed attempt to decrease or discontinue steroids within 8 weeks of screening , and a Crohn 's Disease Activity Index score of < or =150 points . Patients were randomized to receive intravenous CDP571 10 mg/kg or placebo 8-weekly through to week 32 . Steroids were then tapered using a defined schedule . The primary efficacy endpoint was the percentage of patients with steroid sparing , defined as discontinuation of steroid therapy without a disease flare ( Crohn 's Disease Activity Index score > or =220 points ) at week 36 . RESULTS Steroid sparing occurred in 53 of 181 ( 29.3 % ) CDP571 patients and 33 of 90 ( 36.7 % ) placebo patients ( P = 0.24 ) . Adverse events occurred at similar frequencies in both treatment groups . CONCLUSIONS CDP571 was ineffective for sparing steroids in patients with steroid-dependent Crohn 's disease . CDP571 was well tolerated .
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Intervention_Pharmacological
CDP571
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
CDP571
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
prednisone
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Intervention_Control
intravenous CDP571 10 mg/kg or placebo
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Intervention_Pharmacological
therapy
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Intervention_Pharmacological
CDP571
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Intervention_Control
placebo
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Intervention_Pharmacological
CDP571
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Intervention_Pharmacological
CDP571
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Outcome_Physical
percentage of patients with steroid sparing
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Outcome_Physical
Steroid sparing
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Outcome_Adverse-effects
Adverse events
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Outcome_Adverse-effects
sparing steroids
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Participant_Condition
More than 50 % of patients with Crohn 's disease
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Participant_Condition
Steroid dependence was defined as use of prednisolone or prednisone ( 15-40 mg/day ) or budesonide ( 9 mg/day ) for > or =8 weeks , a previous failed attempt to decrease or discontinue steroids within 8 weeks of screening , and a Crohn 's Disease Activity Index score of < or =150 points .
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Participant_Condition
patients with steroid-dependent Crohn 's disease .