antibody to TNF-alpha (trial of use in Crohn's disease)

Last reviewed 01/2018

A chimeric antibody to tumour necrosis factor alpha was compared to placebo in 108 patients with moderate to severe Crohn's disease which was resistant to standard therapy.

The trial was randomised, double-blind and placebo-controlled.

All patients had scores on the Crohn's disease activity index of between 220 and 400.

Patients were randomised to a single infusion of:

  • placebo
  • cA2 antibody - 5 mg/kg
  • cA2 antibody - 10 mg/kg
  • cA2 antibody - 20 mg/kg

The results were:

  • the proportion of patients with a clinical response at 12 weeks was:
    • 17% of placebo group
    • 81% of 5 mg/kg group
    • 50% of 10 mg/kg group
    • 64% of 20 mg/kg group
    • p<0.001 for cA2 group as a whole vs. placebo

  • the proporton of patients entering remission during the 12 week study:
    • 33% of the groups receiving cA2
    • 4% of the placebo group
    • p=0.005

  • the rates of adverse effects were similar

The conclusion is that the anti-TNF-alpha monoclonal antibody is an effective short-term treatment for moderate to severe treatment-resistant Crohn's disease.