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FDA approves Stelara for ulcerative colitis
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The FDA on Monday approved Stelara for the treatment of adults with moderately to severely active ulcerative colitis, according to a press release from the manufacturer.
“Ulcerative colitis is a chronic and progressive disease that can have a significant impact on patients, often disrupting their day-to-day lives with frequent and urgent needs for bowel movements that can be accompanied by pain and cramping,” William J. Sandborn, MD, chief of the division of gastroenterology and professor of medicine at UC San Diego School of Medicine, said in the release. “The FDA approval of Stelara for UC represents an exciting milestone, offering patients a new option that has demonstrated improvement of the histology and endoscopic appearance of the intestinal lining, while also offering patients the potential for response and remission without the need for steroids.”
The approval of ustekinumab (Stelara, Janssen) – a human IL-12 and IL-23 antagonist – is based on data from the phase 3 UNIFI trial, which demonstrated that ustekinumab induced and maintained clinical remission in a significantly greater proportion of adults with moderately to severely active UC compared with placebo.
“Many of us are already familiar with the efficacy and safety of ustekinumab in Crohn’s disease given that it has been commercially available for more than 3 years now,” Edward V. Loftus Jr., MD, Chief Medical Editor of Healio Gastroenterology and Liver Disease, said in an interview. The approval was based on the UNIFI induction and maintenance trials, which was published late last month in The New England Journal of Medicine. Along with the usual endpoints, ustekinumab was found to be significantly more effective than placebo at inducing and maintaining a combination endpoint of both endoscopic and histologic improvement.”
Loftus continued to say how ustekinumab is a welcome addition to the armamentarium.
“Time will tell us how and where to position this in the treatment algorithm,” he said.
The first dose of ustekinumab will be administered intravenously in a health care facility. After that, the remaining doses will be given subcutaneously 8 weeks after the first dose and then every 8 weeks thereafter.
“Because of the individual nature of ulcerative colitis, what works for one patient may not work for another,” Caren Heller, MD, MBA, chief scientific officer at the Crohn’s & Colitis Foundation, said in the release. “That is why it is so critical that our ulcerative colitis patients have many different treatment options available to them. The approval of Stelara is extremely important for patients living with moderate to severe ulcerative colitis. Stelara gives patients another option to, hopefully, induce remission and help manage their disease.”