Treatment with ustekinumab resulted in high rates of remission among patients with Crohn’s disease.
Findings from a new study suggest that a biologic drug used to treat arthritis may also be effective in patients with Crohn’s disease.
In a study published by the New England Journal of Medicine, investigators found that ustekinumab was able to induce response and remission in patients with moderate-to-severe Crohn’s disease.
Ustekinumab is a human interleukin-12 and interleukin-23 antagonist, which are proteins that regulate the immune system, and are involved with inflammatory diseases. The drug was first approved (under the brand name Stelara) by the FDA in 2009 for psoriasis, and has since received approvals for the treatment of psoriatic arthritis, and patients with Crohn’s disease who did not respond to standard treatments.
“A high percentage of the patients in the study who had not responded to conventional therapies were in clinical remission after only a single dose of intravenous ustekinumab,” said William J. Sandborn, MD, professor of medicine at UC San Diego School of Medicine and director of the Inflammatory Bowel Disease Center at UC San Diego Health. “Finding effective new treatment options for this patient population is critical because Crohn’s disease can dramatically impact a person’s quality of life. Patients suffering from this disease may go to the bathroom up to 20 times a day and experience abdominal pain, ulcers and a reduced appetite.”
Crohn’s disease is a chronic condition that affects approximately 700,000 people in the United States, and commonly affects the small intestine where it joins the large intestine, although it can affect any part of the gastrointestinal tract.
The disease is typically treated with glucorticoids, immunosuppressants, TNF inhibitors, or integrin inhibitors, which may lead to an uptick in infections among these patients.
“The drawbacks of these therapies include an increased risk of infection and cancer, and limited efficacy,” Dr Sandborn said. “Ustekinumab has not been associated with an increased risk of serious adverse events.”
At 6 weeks of treatment with intravenous ustekinumab in either 130 mg or 6 mg per kilogram, patients had a higher remission response compared with patients receiving the placebo.
Subcutaneous injections of ustekinumab administered every 8 to 12 weeks was seen to maintain remission in these patients.
These findings suggest that this biologic drug could potentially be used to treat Crohn’s disease without negative side effects, such as an increase in the risk of infection, according to the study.
“This study indicates that ustekinumab may have a long duration of action, a likelihood that may become better understood in future trials,” Dr Sandborn concluded. “Our current findings offer hope for those suffering from this debilitating gastrointestinal tract disease.”