Janssen presents study to show long-term safety profile for Stelara®

The latest analysis presented by the Janssen Pharmaceutical Companies of Johnson & Johnson demonstrated long-term safety profile for ustekinumab drug, sold under the brand name Stelara® in older patients.

The new analysis that pooled safety data from 13 clinical studies across approved indications, was presented at United European Gastroenterology Week (UEGW).

Approved indications included adults with moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.

These data show rates of key safety events among adults 60 years and older treated with the medicine for up to five years were similar to rates observed with placebo during the control phase of these trials.

Jansssen said the study represents an important group, as patients 60 years old and older are at a higher risk of disease and therapy-associated morbidity, which could lead to disease management challenges.

Key findings of the study included no - increased risk of malignancy with ustekinumab usage.

Professor Subrata Ghosh, chair and head of Department of Medicine, University College Cork, Ireland and lead study investigator of the pooled safety analysis, said: “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.”