Dr Stephan Targan and colleagues undertook a randomized placebo-controlled trial to assess the efficacy of natalizumab induction therapy in patients with Crohn's disease.
The team identified 509 patients with moderately to severely active Crohn's disease.
The patients had active inflammation characterized by elevated C-reactive protein concentrations.
The research team randomized the patients to to receive natalizumab 300 mg or placebo intravenously at Weeks 0, 4, and 8.
|26% with natalizumab had sustained remission|
The team's primary end point was induction of response.
The researchers' additional efficacy end points included the proportion of patients with sustained remission, and response or remission over time.
The researchers found that a response at Week 8 sustained through Week 12 occurred in 48% of natalizumab-treated patients.
The team noted that 32% of patients receiving placebo had a response during the same time period.
The team found that sustained remission occurred in 26% of natalizumab-treated patients vs 16% of patients receiving placebo.
Week 4 response rates were 51% for natalizumab- and 37% for placebo-treated patients.
The team observed that responses remained significantly higher at subsequent assessments in natalizumab-treated patients.
Natalizumab-treated patients also had significantly higher remission rates at Weeks 4, 8, and 12.
The researchers noted that the frequency and types of adverse events were similar between treatment groups.
Dr Targan's team concluded, "Natalizumab induced response and remission at Week 8 that was sustained through Week 12."
"Response and remission rates for natalizumab were superior to those for placebo at Weeks 4, 8, and 12."
"This demonstrates the early and sustained efficacy of natalizumab as induction therapy in patients with elevated C-reactive protein and active Crohn's disease."
"Natalizumab was well tolerated in this study."