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October 22, 2019

Janssen reports two-year UNIFI data for Stelara in ulcerative colitis

Janssen Pharmaceutical has reported two-year results from the long-term extension of the Phase III UNIFI clinical trial of Stelara (ustekinumab) in adults with moderately to severely active ulcerative colitis (UC).

Stelara is a human IL-12 and IL-23 antagonist approved by the US Food and Drug Administration (FDA) for moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active UC.

The UNIFI study investigated the safety and efficacy of induction and dose maintenance of the drug in patients with an inadequate response or intolerance to standard or biologic treatments.

Patients who experienced a clinical response in the eight-week induction study were eligible for the 44-week maintenance study. The ongoing long-term extension of the Phase III trial involves a follow-up of three years after the maintenance study.

The latest two-year data includes 399 patients who are part of the long-term extension and were administered with 90mg subcutaneous Stelara every 12 or eight weeks, or placebo.

It was observed that most of the participants who experienced symptomatic remission with the drug maintained remission to week 92.

Around 81% to 90% of subjects treated with Stelara every 12 weeks were in symptomatic remission between weeks 44 to 92, while the proportion was 83-91% in those in the every-eight-weeks arm.

Janssen Research & Development vice-president and gastroenterology disease area leader Jan Wehkamp said: “The Phase III UNIFI two-year data underscore our commitment to advancing research and development in inflammatory bowel diseases.

“We are proud to present these results for the first time at UEGW because we recognise the significant unmet needs that continue to persist in treating the life-altering symptoms of moderately to severely active UC.”

The company presented the two-year data at the 27th United European Gastroenterology Week (UEGW) congress.

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