Dr Yoon-Kyo An, A/Prof Graham Radford-Smith, A/Prof Jakob Begun
Mater Hospital, Brisbane (Lead Site). This study is being conducted across 18 Australian sites including 12 ANZ IBD consortium sites.
Therapeutic options for CD remain fairly limited. In Australia, ustekinumab is one of the few biologics available to patients who are refractory or intolerant to first line corticosteroid and thiopurine treatments. In addition, in the >10yrs which biologics have been available to CD patients in Australia, many patients have either lost response, developed anti-drug antibodies (ADA) or developed intolerances or idiosyncratic reactions to TNF antagonists and vedolizumab. Therefore alternative therapies such as Ustekinumab are required for disease management.
There is limited real-world data on the use of ustekinumab in Crohn’s disease. In addition, the predictors of response to ustekinumab therapy are unknown.
This study aims to determine real world outcomes in CD patients on ustekinumab, to understand the effect of concomitant immunomodulator use on clinical response and explore clinical factors and biomarkers that may aid in clinical decision making about which patients will respond to therapy.
We are aiming to recruit 200 patients across out sites who have an established diagnosis of Crohn’s disease, moderate to severe disease (CDAI ≥ 300) and are eligible for ustekinumab as per PBS criteria.