Psoriasis drug shows potential for crohn’s disease

Taken from the New England Journal of Medicine (NEJM) – by Bruce Sylvester – Ustekinumab, a drug used to treat psoriasis, appears to decrease the debilitating effects of Crohn’s disease, researchers reported in the October 18, 2012 issue of the NEJM/New England Journal of Medicine.

“Our biggest challenge in treating patients with Crohn’s Disease is managing patients whose bodies are resistant to tumor necrosis factor (TNF) inhibitors such as Remicade, Humira and Cimzia,” said William Sanborn, MD, principal investigator and chief of the Division of Gastroenterology at the UC San Diego School of Medicine, San Diego, California. “Ustekinumab blocks two proteins that cause inflammation, interleukin 12 and 23. This finding is a significant first step towards a new treatment option for these patients.”

As background, the authors noted that one-third of patients with moderate-to-severe Crohn’s Disease do not respond to current standard treatment with TNF inhibitors, and another one-third of patients only achieve a temporary response.

The investigators enrolled 526 subjects from 12 countries. Subjects were at least 18 years-old and had a confirmed diagnosis of Crohn’s Disease for at least three months.

The subjects were treated for 36 weeks in the placebo-controlled study. They were given an intravenous dose of ustekinumab or placebo at the beginning of the study, and subcutaneous dosing every eight weeks.

The researchers reported significant and sustained benefits for actively treated subjects beginning as early as six weeks into therapy.

Among patients treated, serious infection was reported in five patients and a basal-cell carcinoma, a form of skin cancer, was reported in one patient.

“These promising initial results are now being followed up and confirmed with additional Phase 3 induction trials,” said Dr. Sandborn, director of the Inflammatory Bowel Disease Center at UC San Diego Health System. “Our goal is to increase clinical response and put the disease in remission to improve the patient’s quality of life.”

The study was funded by Janssen Research & Development.