ABSTRACT Background Ustekinumab is an effective therapy for the management of Crohn's disease. Australia is unique, as ustekinumab can be prescribed as first‐line biologic therapy, and there is high concomitant immunomodulator use. Aim To evaluate the real‐world efficacy and safety of ustekinumab in moderate to severe Crohn's disease. Methods A multicentre prospective cohort study was conducted at 19 Australian centres between September 2019 and April 2022. Clinical assessments were performed at baseline, 3, 9 and 15 months. Logistic regression analyses were performed to identify predictors of clinical response and remission. Results 197 patients (male 45.2%) were included: 58.9% were biologic‐naïve and 50.0% were on concomitant immunomodulators. Clinical response rates were 75.4%, 75.5% and 72.3% at 3, 9 and 15 months, respectively with corresponding clinical remission rates of 45.8%, 51.6% and 55.5%. Clinical response and remission rates at 3 and 9 months were significantly higher in bio‐naïve patients compared with biologic‐exposed ( p < 0.01); but no significant differences were seen with concomitant immunomodulator use. Dose escalation was required in 31.5% of patients. Ustekinumab was discontinued in 12.7% of patients. The cumulative probability of maintaining ustekinumab treatment at 15 months was 84.4%. Despite 161 adverse events reported, including 41 hospitalizations, only eight patients required treatment discontinuation due to adverse events. Conclusions This real‐world study on the use of ustekinumab in Crohn's disease showed that short‐term clinical response and remission rates are higher in bio‐naïve compared with bio‐exposed patients, with a high persistence rate at 15 months. The addition of an immunomodulator did not significantly impact outcomes. Ustekinumab was found to be safe in most patients.
An et al. (2025) studied this question.