Ustekinumab Demonstrates Favorable Safety Profile in Patients With IBD

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Rates of key safety events, such as malignancies and major adverse cardiovascular events, were comparable among patients receiving placebo and ustekinumab.

Cumulative ustekinumab safety data in inflammatory bowel disease (IBD) through 5 years in patients with Crohn’s disease (CD) and 4 years in ulcerative colitis (UC) reported a favorable safety profile that continues to support the well-established safety experience of ustekinumab treatment across approved indications, according to data presented at Digestive Disease Week (DDW) 2023.1

“A previous pooled analysis of long-term safety data reported a favorable UST safety treatment profile for IBD,” wrote Bruce E Sands, MD, Icahn School of Medicine at Mount Sinai, New York, and colleagues. “Here, we present results of the final cumulative analysis of long-term safety data from ustekinumab studies through up to 5 years in CD and 4 years in UC.”

Data from 6 phase 2 and phase 3 IBD studies evaluating ustekinumab were pooled. In the phase 3 studies, patients received a single intravenous dose of either placebo or ustekinumab (130 mg or ~6mg/kg) induction dose followed by standard care maintenance doses of either the placebo or ustekinumab (90mg every 8 or 12 weeks). Concomitant immunomodulators and corticosteroids were allowed throughout the trials. All patients who were treated with ≥1 dose of ustekinumab were included in the analysis. The safety outcomes were presented using number of adverse events per 100 patient-years (PY) of follow-up as well as 95% confidence interval (CI).

In the final pooled safety data, 2575 patients received ustekinumab with 4826 PYs of follow-up data. Rates of key safety events, such as malignancies and major adverse cardiovascular events (MACE), were comparable among patients receiving placebo and ustekinumab or not higher for ustekinumab.

The most frequently occurring adverse events in patients receiving the placebo or ustekinumab, excluding diseases under study, were headache (16.66 vs 11.60, respectively), arthralgia (15.91 vs 11.23, respectively), abdominal pain (13.79 vs 9.86, respectively), nausea (11.35 vs 7.13, respectively), and pyrexia (11.35 vs 5.91, respectively). Commonly occurring infections were nasopharyngitis (17.82 vs 19.10, respectively) and upper respiratory tract infection (11.78 vs 9.80, respectively).

The most commonly reported serious infections, which were pneumonia, cellulitis, anal abscess, and abdominal abscess, were not higher in patients treated with ustekinumab when compared with the placebo cohort, with the exception of gastroenteritis (placebo cohort: 0.11 vs ustekinumab: 0.25). No lymphomas were reported, although 9 deaths were reported in the ustekinumab group (0.00 [0.00, 0.32] placebo vs 0.19 [0.09, 0.35] ustekinumab), with 6 in the CD category and 3 in UC category (all categorized as unrelated to study agent).


  1. Sands BE, Feagan BG, Ott E, Gasink C, et al. SAFETY OF USTEKINUMAB IN IBD: FINAL POOLED LONG-TERM SAFETY ANALYSIS THROUGH 5 YEARS IN CD AND 4 YEARS IN UC. Abstract presented at Digestive Disease Week (DDW) 2023 Annual Meeting. Chicago, IL. May 6-10, 2023.