Tumor necrosis factor blockade has been shown to be an effective treatment strategy in Crohn's disease.
Adalimumab is a human immunoglobulin G1 monoclonal antibody targeting tumor necrosis factor.
Dr Stephen Hanauer and colleagues evaluated the efficacy of adalimumab induction therapy in patients with Crohn's disease.
The researchers performed a randomized, double-blind, placebo-controlled, dose-ranging trial.
The researchers randomized a total of 299 patients with moderate to severe Crohn's disease naive to anti-tumor necrosis factor therapy.
The patients received subcutaneous injections at weeks 0 and 2 with adalimumab 40 mg/20 mg, 80 mg/40 mg, or 160 mg/80 mg or placebo.
The primary endpoint was demonstration of a significant difference in the rates of remission at week 4 among the 2 higher dose, and placebo groups.
| Remission at week 4 in the highest dose treatment group was 36%|
Remission was defined as a Crohn's Disease Activity Index score of less than 150 points.
The team discovered the rates of remission at week 4 in the lowest, mid and highest dose treatment groups was 18%, 24%, and 36%, respectively.
The rate of remission was 12% in the placebo group.
Adverse events occurred at similar frequencies in all 4 groups except injection site reactions, which were more common in adalimumab-treated patients.
Dr Hanauer's team concluded, “Adalimumab was superior to placebo for induction of remission in patients with moderate to severe Crohn's disease naive to anti-tumor necrosis factor therapy.
The optimal induction dosing regimen for adalimumab in this study was 160 mg at week 0 followed by 80 mg at week 2.”
“Adalimumab was well tolerated.”