Adalimumab, a fully human tumor necrosis factor antagonist, is an effective treatment Crohn's disease.
It is effective in patients who are naive to the chimeric tumor necrosis factor antagonist, infliximab.
No anti-tumor necrosis factor agent has been evaluated prospectively in patients with Crohn's disease who had responded to another anti-tumor necrosis factor agent and then lost that response or were intolerant of the agent.
Dr William Sandborn and colleagues from Rochester, USA determined whether adalimumab induces remissions more frequently than placebo in Crohn's disease.
The patients had symptoms despite infliximab therapy or who cannot take infliximab because of adverse events.
The team conducted a 4-week, randomized, double-blind, placebo-controlled trial between 2004 and 2005.
|21% in the adalimumab group achieved remission at week 4|
|Annals of Internal Medicine|
The team assessed 325 adults 18 to 75 years of age who had a history of Crohn's disease for 4 months or more that was moderate to severe at baseline.
Patients were randomly assigned to receive induction doses of adalimumab, 160 mg and 80 mg, at weeks 0 and 2, respectively, or placebo at the same time points.
The primary end point was induction of remission at week 4.
Decreases in Crohn's Disease Activity Index score by 70 or more and 100 or more points were also measured.
The researchers found a total of 301 patients completed the trial.
The team noted that 21% of patients in the adalimumab group versus 7% of those in the placebo group achieved remission at week 4.
The absolute difference in clinical remission rates was 14% points.
The team found a 70-point response occurred at week 4 in 52% of patients in the adalimumab group versus 34% of patients in the placebo group.
The research team observed that absolute difference in 70-point response rates was 18% points.
The team noted that 2 of 159 patients in the adalimumab group, and 4 of 166 patients in the placebo group discontinued treatment because of adverse events.
The team found that no patients in the adalimumab group, and 4 of 166 patients in the placebo group had a serious infection.
Dr Sandborn's team concluded, "Adalimumab induces remissions more frequently than placebo in adult patients with Crohn's disease who cannot tolerate infliximab or have symptoms despite receiving infliximab therapy."