Safety Profile of Ustekinumab Favorable in IBD, Psoriatic Arthritis, Psoriasis


The rates of adverse events was similar across all 4 indications in comparison to the placebo group.

Millie Long, MD

Millie Long, MD

While ustekinumab is prescribed across different indications, including Crohn’s disease, ulcerative colitis, psoriatic arthritis, and psoriasis, new research presented at the 2021 American College of Gastroenterology (ACG) Annual Meeting shows the treatment is safe in all 4 indications.

A team, led by Millie D. Long, MD, MPH, FACG, University of North Carolina, presented an integrated analysis of pooled safety data of phase 2 or 3 long-term safety data of inflammatory bowel disease (IBD) studies through up to 5 years in Crohn’s disease and 2 years in ulcerative colitis and psoriatic disease studies through up to 5 years in psoriasis and 1 year in psoriatic arthritis.

Four Indications

There are a number of US Food and Drug Administration (FDA) approved indications for ustekinumab, including psoriasis (2009), psoriatic arthritis (2013), Crohn’s disease (2016), and ulcerative colitis (2019).

During this time there has been a number of safety studies showing the treatment is in fact safe, including an integrated safety data analysis through year 1 and the 2020 IBD pooled Safety Dataset.

Overall, the investigators examined data from 13 studies for the 4 approved indications, including studies involving concomitant immunomodulators and corticosteroids for IBD and psoriatic arthritis, but not psoriasis patients. Every patient received at least 1 dose of ustekinumab.

Safety outcomes were classified as events per 100 patient-years of follow-up. Also, the placebo-controlled period was 12 weeks in the majority of psoriasis studies and 16 weeks in most of the psoriatic arthritis.

Ustekinumab Safety

Overall, there were 6710 patients treated with ustekinumab, accounting for 13,807 follow-up years, compared to 2501 patients treated with placebo accounting 1244 of person-years of follow-up.

The rates of events per 100 person-years were similar between both ustekinumab treated patients and placebo groups, with the most frequent adverse events being nasopharyngitis (20.83 vs 20.87), upper respiratory tract infection (13.51 vs 14.53), arthralgia (13.99 vs 7.01), abdominal pain (10.77 vs 4.01), and diarrhea (6.67 vs 3.88).

The most serious infections reported in the placebo group compared to the ustekinumab group were anal abscess (0.72 vs 0.17), pneumonia (0.32 vs 0.14), and cellulitis (0.16 vs 0.11). However, events of malignancy and death were not frequently report, especially in the placebo group.

“The safety profile of ustekinumab across pooled indications was favorable through up to 5 years, confirming the well-established safety profile of ustekinumab in psoriatic and IBD indications,” the authors wrote.

The study, “Safety of Ustekinumab Across Approved Adult Indications: Pooled Safety Analysis in Crohn’s Disease, Ulcerative Colitis, Psoriasis, and Psoriatic Arthritis Through up to 5 Years,” was published online by ACG.

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