FDA OKs Ustekinumab (Stelara) for Moderate to Severe UC

Megan Brooks

October 21, 2019

The US Food and Drug Administration (FDA) has approved ustekinumab (Stelara, Janssen) for the treatment of adults with moderately to severely active ulcerative colitis (UC), according to a company news release.

Since first approved in 2009 for adults with moderate to severe plaque psoriasis, the interleukin-12/23 inhibitor has received four additional indications in the US: adolescents with moderate to severe plaque psoriasis; adults with active psoriatic arthritis; adults with moderately to severely active Crohn's disease (CD); and now adults with moderately to severely active UC.

The approval of ustekinumab for moderately to severely active UC is based on data from the phase 3 UNIFI clinical trial involving 961 adults. Patients received a single intravenous (IV) infusion of ustekinumab (6 mg/kg) followed 8 weeks later by 90 mg subcutaneous (SC) injections every 8 weeks for 44 weeks.

The trial showed that ustekinumab was more effective than placebo for inducing and maintaining remission. In addition, significantly more patients treated with ustekinumab achieved endoscopic improvement and mucosal healing.

The overall safety profile of ustekinumab in UC was consistent with what has been observed across all approved indications of the drug.

The UNIFI study results were published September 26 in the New England Journal of Medicine, and reported by Medscape Medical News at that time. 

UC affects about 910,000 people in the US, according to Janssen.

The disease 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," UNIFI study investigator William Sandborn, MD, chief of the Division of Gastroenterology at UC San Diego School of Medicine in California, said in the Janssen news 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," said Sandborn.

"Because of the individual nature of ulcerative colitis, what works for one patient may not work for another. That is why it is so critical that our ulcerative colitis patients have many different treatment options available to them," Caren Heller, MD, MBA, chief scientific officer at the Crohn's & Colitis Foundation, said in the release.

"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," said Heller.

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