Abatacept for Crohn's disease and ulcerative colitis
William J Sandborn1, Jean-Frederic Colombel, Bruce E Sands
1Division of Gastroenterology, University of California San Diego, La Jolla, California, 92093-0956,USA. wsandborn@ucsd.edu
Gastroenterology
|April 17, 2012
Summary
Abatacept (a selective costimulation modulator) did not prove effective in treating moderate-to-severe Crohn
Area of Science:
- Immunology
- Gastroenterology
- Clinical Trials
Background:
- The efficacy of abatacept, a selective costimulation modulator, for treating Crohn's disease (CD) and ulcerative colitis (UC) was previously unknown.
- Inflammatory bowel diseases like CD and UC involve complex immune dysregulation.
Purpose of the Study:
- To evaluate the efficacy and safety of abatacept as induction and maintenance therapy in adults with active, moderate-to-severe CD and UC.
- To determine if abatacept offers a viable treatment option for these chronic inflammatory conditions.
Main Methods:
- Four placebo-controlled trials were conducted, involving 451 CD patients and 490 UC patients for induction therapy.
- Patients received varying doses of abatacept or placebo, with subsequent maintenance therapy for responders.
- Safety and efficacy were assessed over a 52-week period.
Main Results:
- Abatacept did not demonstrate statistically significant clinical response rates compared to placebo in induction therapy for either CD or UC.
- Maintenance therapy also showed no significant difference in remission rates between abatacept and placebo groups for CD and UC.
- The safety profile of abatacept was comparable to placebo across the studied populations.
Conclusions:
- Abatacept was found to be not efficacious for the treatment of moderate-to-severe Crohn's disease.
- Abatacept also demonstrated a lack of efficacy in the treatment of moderate-to-severe ulcerative colitis.
- These findings suggest abatacept is not a suitable therapeutic option for these indications.
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