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The results of the randomised controlled trial of adalimumab (ADA) for inducing remission in outpatients with moderate to severely active ulcerative colitis (UC) are published in this issue of Gut (see page 780).1 On the face of it, the response appears modest: at week 8, 18.5% of those induced with ADA160/80, then 40 mg every other week entered remission, compared with 9.2% (p=0.031) in the placebo group and just 10.0% in the ADA80/40 group (p=0.833 vs placebo). The results will inevitably be compared with those of infliximab (IFX),2 for which the pooled 8 week remission rates were 38.8% of those randomised to 5 mg/kg in ACT 1 and 14.9% on placebo (p<0.001), but caveats are necessary.
As with any clinical trial in UC, the first thing is to check the activity index, inclusion criteria, definitions of response, remission and statistical approach. The ADA study can only reasonably be compared with the induction phase of ACT 1, because it recruited patients with active disease refractory to (or intolerant of) steroids and immunomodulators. However, the two trials turn out to be more comparable than most. Both used the Mayo Clinic activity index,3 the same definition of remission (Mayo Clinic score ≤2, with no subscore >1) and response (decrease in Mayo score and 30% of starting value, with a 1 point decrease or rectal bleeding subscore ≤1). Both had similar patient numbers (130/group in ADA, 121 in ACT 1), mean Mayo score on trial entry (8.8±1.61 for ADA vs 8.7±1.56 placebo and 8.5±1.7 vs 8.4±1.8 in ACT 1), age (median 36.5 years (range 18–75) for ADA, mean 42.4±14.3 years for ACT 1), disease duration (6.1 years ADA, 5.9 years ACT 1) …
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