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Data show the safety profile of Ustekinumab in long-term IBD pooled safety dataset was found favorable among bionaive patients.
New findings suggest the safety profile of ustekinumab in a long-term inflammatory bowel disease (IBD) safety dataset was favorable among bionaive patients and considered consistent with the safety profile across approved indications.
These findings were presented at the 2022 Digestive Disease Week Annual Meeting in San Diego, California.
In an interview with HCPLive, Bruce Sands, MD, Dr. Burrill B. Crohn Professor of Medicine, Mount Sinai, highlighted the findings from the ustekinumab phase ⅔ long-term safety data from IBD studies up to 5 years in Crohn’s disease (CD) and 2 years in ulcerative colitis (UC) for bio naive patients.
He noted the SEAVUE study of patients with CD analyzed about 1600 patient-years of exposure data, finding ustekinumab had very similar results compared to placebo regarding safety. It found nasal pharyngitis and upper respiratory infections to be most common, but not at a greater rate than placebo, as well as only a handful of observed malignancies.
“In conclusion, basically, we find that in the bio naive patients, there's an extraordinarily good safety profile for ustekinumab in treating our patients with IBD,” Sands said.
Sands noted that usetkinumab appeared to be safer than the anti-TNF biologics, while it additionally does not require combination therapy to enhance efficacy.
“I think you'll see accumulated data from real world evidence but so far, if you look at those data, it also looks like ustekinumab is still quite safe,” Sands concluded.
The study,” Long-Term Cumulative Safety of Ustekinumab in Bio Naive Patients with Crohn’s Disease and Ulcerative Colitis,” was presented at DDW 2022.