Ustekinumab Gets Expanded European Label With New Ulcerative Colitis Indication

Janssen, a unit of Johnson & Johnson, announced this week that the European Commission has approved its ustekinumab (Stelara) for the treatment of moderate to severe ulcerative colitis (UC). Also approved in the European Union to treat plaque psoriasis, psoriatic arthritis, and Crohn disease, the biologic is the first available therapy that targets the interleukin-12 and -23 pathway.

“Today marks a significant milestone in the treatment of ulcerative colitis,” said Jan Wehkamp, MD, vice president and gastroenterology disease area leader of Janssen Research & Development, LLC, in a statement. “Many hundreds of thousands of people in Europe struggle with one of the 2 types of inflammatory bowel disease—Crohn disease and ulcerative colitis—and are in urgent need of effective treatment options. Ustekinumab has been available to people with Crohn disease since it was approved in 2016, and thanks to the patients who enrolled in the UNIFI clinical trial program 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.”

Approval in the new indication was based on data from the phase 3 UNIFI trial. In the trial, 961 patients with UC were randomized to receive either a single intravenous dose of placebo, 130 mg of ustekinumab, or a weight-tiered dose of ustekinumab.

Evaluation at week 8 showed that 15.6% of patients receiving 130 mg ustekinumab and 15.5% of patients receiving a weight-tiered dose achieved clinical remission, compared with 5.3% of patients receiving placebo (P <.001).

Through week 8, adverse events (AEs), serious AEs, and infections were reported in similar proportions across all 3 groups. There were no malignancies, opportunistic infections, or tuberculosis infections reported.

A further maintenance study of 44 weeks included 523 patients with UC who were in clinical remission after the 8-week study. Patients were randomized to receive placebo or a subcutaneous dose of 90 mg of ustekinumab every 8 weeks or every 12 weeks. In this study, 43.8% and 38.4%, respectively, of the patients in the 2 ustekinumab groups were in clinical remission at week 44 (P <.001) versus 24.0% of the placebo group (<.002)

As ustekinumab advances with its new indication, it also faces the specter of biosimilar competition. Alvotech is developing a biosimilar, which it plans to market with partner Fuji Pharma in Japan, and NeuClone announced earlier in 2019 that it will start a phase 1 clinical trial of its biosimilar, which it is developing with the Serum Institute of India, later this year.