Not all patients with Crohn's disease respond or maintain response to anti-tumor necrosis factor (TNF) agents and alternative treatment is necessary.
Natalizumab, a monoclonal antibody to alpha-4 integrin approved for Crohn's disease, has demonstrated efficacy in randomized clinical trials.
Dr Kane and colleagues from Illinois, USA described their experience with natalizumab in clinical practice at Mayo Clinic Rochester.
Consecutive patients prescribed natalizumab for active Crohn's disease were invited to participate and were followed prospectively.
The team recorded the incidence of infection, hospitalization, neoplasm, or other adverse events.
Clinical activity was assessed using the Harvey–Bradshaw Index at each 30-day infusion visit.
|46% had clinical response|
|Inflammatory Bowel Diseases|
Between 2008 and 2010, 36 patients were prescribed natalizumab, and 30 agreed to participate.
The research team found that the median disease duration was 9 years.
The team noted that 23 patients had prior exposure to 2 anti-TNF agents, and 7 to 1 agent.
The team observed that all patients experienced at least one adverse event.
The researchers found that none of the 13 patients in whom natalizumab was stopped discontinued due to adverse events.
The team noted that 5 patients had infusions held for infection.
No patient developed progressive multifocal leukoencephalopathy.
The research team found that 46% had clinical response.
The cumulative probability of achieving complete response within 1 year was 56%.
The researchers noted that 4 of 7 patients were weaned off corticosteroids.
Dr Kane's team concludes, "In our experience with natalizumab in clinical practice, adverse events were manageable and did not result in treatment cessation."
"No progressive multifocal leukoencephalopathy cases were seen, and clinical response was similar to that in clinical trials."
"Natalizumab results in clinical benefit in patients who have active disease and have failed anti-TNF therapy."