Janssen’s bowel disease drug shown to be safe for use in older patients

pharmafile | October 6, 2021 | News story | Research and Development  

The Janssen Pharmaceutical Companies of J&J have announced that STELARA® (ustekinumab) has a high safety profile in older patients across approved indications, such as inflammatory bowel disease, where limited biologics safety data currently exists.

The analysis of STELARA collated safety data from 13 clinical studies. These data show rates of key safety events among adults 60 years and older treated with ustekinumab for up to five years were similar to rates with placebo during the trial’s control phase.

Approved indications included adults with moderate to severe Crohn’s disease (CD), moderate to severe ulcerative colitis (UC), moderate to severe plaque psoriasis (Pso), and active psoriatic arthritis (PsA). These results account for an important and underrepresented patient population, as patients 60 years old and older are at a higher risk of disease and therapy-associated morbidity, which can result in difficulties with disease management.

Professor Subrata Ghosh, Chair and Head of Department of Medicine, University College Cork, Ireland, commented: “Little has been intentionally explored about the safety profile of biologics in patients aged 60 and older with inflammatory bowel disease, as this population is often limited in number in clinical trials.

“This analysis arms physicians with data to consider when treating older patients with ustekinumab, given the safety profile observed across all approved indications.” 

Jan Wehkamp, MD, PhD, Vice President, Gastroenterology Disease Area Leader, Janssen Research & Development, LLC, added: “Continuing to follow occurrences of safety events in older adults who are treated with our therapies is valuable information that can help physicians evaluate treatment options for their patients.

“These data build on the body of evidence for the safety profile of ustekinumab and underscore our commitment to developing meaningful therapies for people of all ages who are living with an untreated or undertreated immune-mediated disease.”

Lina Adams

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