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Australian Real-World Effectiveness and Safety of Ustekinumab for the Treatment
of Crohn s Disease: Results of the AURORA Study, Including the ANZIBD Consortium
#MMPMID41384275
An YK
; Lindsay N
; Allan N
; Khoo E
; Fernandes R
; Gilmore R
; Amiss A
; Pham H
; Ooi SY
; Thin L
; Lightowler D
; Connor SJ
; Williams A
; De Cruz P
; Li Wai Suen CFD
; Kariyawasam V
; Mitrev N
; Ghaly S
; Andrews JM
; Christensen B
; Sparrow MP
; White LS
; Bryant R
; Ding NS
; Leong RW
; Van Langenberg DR
; Seltenreich H
; Subramaniam K
; Radford-Smith G
; Begun J
JGH Open
2025[Dec]; 9
(12
): e70322
PMID41384275
show ga
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.