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AMG 827 treatment led to worsening symptoms among patients with Crohn’s disease

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SAN DIEGO — Researchers stopped a study on the safety and efficacy of AMG 827 in patients with Crohn’s disease because of worsening symptoms, according to data presented at the 2012 Digestive Disease Week Annual Meeting.

In the randomized, double blind, placebo-controlled phase 2 study, patients with moderate-to-severe Crohn’s disease received either placebo or 210 mg, 350 mg or 700 mg AMG 827, an anti-IL-17 receptor monoclonal antibody, with a primary endpoint of remission after 6 weeks.

The study was terminated after a review of safety data from 117 of 216 planned patients indicated a worsening of Crohn’s disease symptoms. At termination, data had been collected from 130 randomly assigned patients, with remission rates at 3% for the 210 mg group, 15% (350 mg), 9% (700 mg) and 3% (placebo). Partial response at 6 weeks was achieved by 16% of the 210 mg group, 27% (350 mg), 15% (700 mg) and 13% (placebo).

Exacerbated symptoms, including adverse events and study withdrawal because of illness progression, occurred in 31% of the 210 mg group, 24% (350 mg), 36% (700 mg) and 9% (placebo). The mean changes at week 6 in Crohn’s Disease Activity Index were 56.7 (96.2) in the 210 mg group, 17.5 (95.1) in the 350 mg group and 74.8 (75.1) in the 700 mg group.

“Overall, the drug didn’t work, [and] a subpopulation actually got worse,” researcher Stephan R. Targan, MD, director of the Inflammatory Bowel Disease Center and the Division of Gastroenterology at Cedars-Sinai Medical Center in Los Angeles, told Healio.com. “There is a population that acts differently for the target vs. the other population, and this speaks to the heterogeneity of what causes inflammation in patients with Crohn’s disease.”

For more information:

Targan SR. #Mo2083: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Moderate to Severe Crohn’s Disease. Presented at: the 2012 Digestive Disease Week Annual Meeting; May 19-22, San Diego.

Disclosures: Researchers reported numerous financial disclosures.