The Janssen Pharmaceutical Companies of Johnson & Johnson has released efficacy and safety data for STELARA (ustekinumab) in Crohn’s disease (CD) and ulcerative colitis (UC), including data from the SEAVUE study, the first study of biologic therapies in patients with CD, presented in a Clinical Science Late-Breaking Abstract Plenary session.
SEAVUE data showed treatment with ustekinumaba demonstrated high rates of clinical remission, corticosteroid-free remission, clinical response and endoscopic response through one year in biologic-naïve patients with moderately to severely active CD, although the primary endpoint of statistical superiority versus adalimumab was not demonstrated. These data are one of 20 abstracts Janssen presented from the company’s gastroenterology pipeline and portfolio at DDW Virtual 2021, which took place 21-23 May.
“As the first head-to-head study of biologic therapies in Crohn’s disease, SEAVUE is filling an important knowledge gap in the gastrointestinal community,” said Bruce Sands, Chief of the Dr. Henry D. Janowitz Division of Gastroenterology at Mount Sinai Hospital and the Dr. Burrill B. Crohn Professor of Medicine (Gastroenterology), at the Icahn Institute for Medicine at Mount Sinai, and SEAVUE study principal investigator. “SEAVUE has generated data that confirm ustekinumab as an important option for people living with moderately to severely active Crohn’s disease who are new to biologic therapy.”
“Until now, there have been no head-to-head trials comparing the safety and efficacy of prescription biologics to treat Crohn’s disease, a chronic condition that can cause persistent and debilitating symptoms which can have a profound impact on a person’s daily life,” said Andrew Greenspan, Vice President, Immunology Medical Affairs, Janssen Scientific Affairs, LLC. “Armed with this new clinical trial data, doctors have a compelling option in ustekinumab for appropriate patients living with Crohn’s disease.”
Image credit: Jannes Jacobs