Jan Wehkamp, MD, PhD: New Long-Term Safety Data for Ustekinumab for Ulcerative Colitis

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The results show 58% of patients treated with ustekinumab were in clinical remission, while 80% were in clinical response.

New data presented during the 18th Congress of the European Crohn’s and Colitis Organization (ECCO), taking place in Copenhagen show the continued long-term safety and efficacy of ustekinumab (STELARA) as a treatment for patients with ulcerative colitis or Crohn’s disease.

The results, from the UNIFI long-term extension study of pooled data from 2575 patients treated with ustekinumab, confirm the positive safety profile of the treatment for patients with moderately to severely active ulcerative colitis for up to 4 years and patients with moderately to severely active Crohn’s disease for up to 5 years.

The analysis show adverse events, serious adverse events, infections, serious infections, major adverse cardiac events, and malignancies were all similar between patients treated with ustekinumab and placebo.

In the study, the investigators randomized the 205 adult patients with a history of moderate to severe ulcerative colitis who had achieved clinical response to treatment with intravenous ustekinumab to receive either ustekinumab 90 mg every 8 weeks or every 12 weeks at baseline of the maintenance study and continued treatment into the long-term extension.

The results show 58% (n = 119) of patients were in clinical remission, 80% (n = 164) were in clinical response, 79.5% (n = 163) of patients were in modified Mayo score response, and 67% (n = 138) of patients showed endoscopic improvement.

In an interview with HCPLive®, Jan Wehkamp, MD, PhD, Vice President, Gastroenterology Disease Area Leader, Janssen Research & Development, explained how the new ustekinumab data adds to what is a growing list of positive studies involving the biologic.

“Overall most patients are not in remission, so they need safe and durable treatments,” Wehkamp said.