- Global Pharma News & Resources

New Analysis Presented by Janssen at United European Gastroenterology Week (UEGW) Demonstrates Long-Term Safety Profile for STELARA® (ustekinumab) in Older Patients Across Approved Indications

New Analysis Presented by Janssen at United European Gastroenterology Week (UEGW) Demonstrates Long-Term Safety Profile for STELARA® (ustekinumab) in Older Patients Across Approved Indications



First examination of safety events in the 60 and over sub-population across ustekinumab indications, including inflammatory bowel disease where relatively little biologics safety data exists, are generally consistent with placebo


Janssen presents 13 abstracts including four oral presentations and two late breakers at UEGW


BEERSE, BELGIUM, 4 October, 2021 – Today, the Janssen Pharmaceutical Companies of Johnson & Johnson announced a new analysis of STELARA® (ustekinumab) pooled safety data from 13 clinical studies across approved indications.1 These data show rates of key safety events among adults 60 years and older treated with ustekinumab for up to five yearsa were similar to rates observed with placebo during the control phase of these trials.1,b Approved indications included adults with moderately to severely active Crohn’s disease (CD), moderately to severely active ulcerative colitis (UC), moderate to severe plaque psoriasis (Pso) and active psoriatic arthritis (PsA) (Oral Presentation OP198).1 These data represent an important patient population, as patients 60 years old and older are at a higher risk of disease and therapy-associated morbidity, which can result in disease management challenges.1


“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,” said Professor Subrata Ghosh, Chair and Head of Department of Medicine, University College Cork, Ireland and lead study investigator of the pooled safety analysis.c “This analysis arms physicians with data to consider when treating older patients with ustekinumab given the safety profile observed across all approved indications.” 


Pooled Safety (Oral Presentation OP198) data show:

Data from 13 Phase 2/3 studies including six studies in CD/UC and seven studies in Pso/PsA for ustekinumab were pooled.1 Of patients 60 years old or older with moderate to severe CD or UC, 214 received ustekinumab, the equivalent of 311 patient years (PYs) of follow up, and 120 received placebo, the equivalent of 97 PYs.1 Across additional approved indications, 811 received ustekinumab (1,590 PYs) and 272 received placebo (143 PYs).1 Number of events across pooled indications were as follows:

  • Overall rates for adverse events (AEs) per 100 PYs were no greater for ustekinumab (269.12) versus placebo (455.9).1
  • Overall rates for infections per 100 PYs were similar between ustekinumab (75.49) and placebo (86.44).1
  • Rates of serious AEs (ustekinumab: 19.88; placebo: 27.19) and serious infections (ustekinumab: 3.33; placebo: 3.49) were similar between ustekinumab and placebo treatment groups.1
  • No increased risk of malignancy with ustekinumab was observed based on a comparison of observed versus expected malignancies.1
  • Overall, the safety profile of ustekinumab-treated patients 60 years old and older from the long-term pooled safety dataset across approved indications did not demonstrate higher rates with ustekinumab versus placebo.1


“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,” said Jan Wehkamp, M.D., Ph.D., Vice President, Gastroenterology Disease Area Leader, Janssen Research & Development, LLC. “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.”


These data are among 13 total abstracts, including three other oral presentations (OP122, OP153, OP199), and two late breakers that Janssen is presenting at UEGW. Late-breaking presentations are:

Editor Details

Last Updated: 06-Oct-2021