Stelara Approved to Treat Moderate to Severe Ulcerative Colitis in Europe

Stelara Approved to Treat Moderate to Severe Ulcerative Colitis in Europe
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Stelara approved in EU

The European Commission (EC) has approved Stelara (ustekinumab) to treat moderately to severely active ulcerative colitis (UC) in adults who are either not responding to, or are intolerant of,  standard therapies or other biologic agents.

The decision was announced by Janssen Pharmaceuticals, Stelara’s developer and part of Johnson & Johnson.

“Today marks a significant milestone in the treatment of ulcerative colitis,” Jan Wehkamp, MD, vice president and Gastroenterology Disease Area leader at Janssen Research & Development, said in a press release. “Many hundreds of thousands of people in Europe struggle with one of the two types of inflammatory bowel disease – Crohn’s disease and ulcerative colitis – and are in urgent need of effective treatment options.”

A branch of the the European Medicines Agency (EMA), the Committee for Medicinal Products for Human Use (CHMP), had recommended Stelara’s approval for this patient group in late July.

Stelara is a biologic agent that works by inhibiting the activity of two proteins, interleukin (IL)-12 and IL-23, which are inflammatory cytokines (molecules that mediate and regulate immune and inflammatory responses) whose levels are abnormally high in patients with inflammatory bowel disease (IBD).

The medication is also approved to treat moderate to severe Crohn’s disease, as well as psoriasis and psoriatic arthritis, in both Europe and the U.S.

EC approval was based on findings from the multicenter, randomized, double-blind and placebo-controlled Phase 3 UNIFI trial (NCT02407236). This study’s main goal was to evaluate the safety and efficacy of Stelara, compared to a placebo, in people with moderate to severe UC. The treatment was given as an intravenous (IV) infusion.

The trial was divided into two phases: an initial induction phase, in which patients received a single dose of Stelara to assess their response to treatment for at least eight weeks; and a maintenance phase, in which patients received multiple doses of the medication over 44 weeks.

Trial’s findings showed that during both phases, patients given Stelara responded favorably to treatment. During the induction phase, 62% of the patients treated with Stelara responded to treatment, whereas only 31% of those given a placebo achieved the same outcome.

In the maintenance phase, depending on how often they received the medication, 48.3% to 57.4% of patients treated with Stelara attained remission, compared to 35.4% of those in the placebo group.

Stelara was generally safe and well-tolerated by patients. The incidence of adverse events, serious adverse events, infections and serious infections were similar among people in both groups during both trial phases. One death due to esophageal varices bleeding (rupture of large veins in the esophagus) was reported during the induction phase. No deaths were reported during the maintenance phase.

“Ustekinumab has been available to people with Crohn’s disease since it was approved in 2016,” Wehkamp said, “and thanks to the patients who enrolled in the UNIFI clinical trial programme and their willingness to participate, we are delighted it will now be available to people with ulcerative colitis, offering them a chance of durable remission and relief from the often painful and debilitating symptoms.”

Janssen submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) requesting Stelara’s U.S. approval for the same indication in December 2018.

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