Abstract
Abstract
Background
Ustekinumab is a human monoclonal antibody targeting interleukin-12 and 23 with established efficacy in inflammatory bowel disease (IBD). Many people receiving ustekinumab do not achieve adequate or sustained response to standard dosing and require dose escalation (DE). We aimed to investigate the frequency and outcomes of escalated dosing regimens in an Australasian cohort.
Methods
Crohn’s Colitis Care (CCCare) is a cloud-based IBD-specific electronic medical record used in routine care across Australia and New Zealand. Data feeds continuously into a de-identified clinical quality registry (CQR). Data were interrogated in November 2023 comparing outcomes and healthcare utilisation prior to and at 12 months post ustekinumab DE. DE was defined as maintenance dosing >90mg subcutaneously Q8 weekly and/or additional induction doses.
Results
A total of 790 people received ustekinumab, with 43.4% on DE therapy. Most of the cohort had Crohn’s disease (86.1%), followed by ulcerative colitis (11.3%) and IBD-unclassified (1.6%). The median age for the total cohort was 40 years (IQR 30-52) with an even gender distribution (50.3% female). The median age at diagnosis was 25 (IQR 18-38) with a median time to DE of 6 months (IQR 1-15). Age, age at diagnosis and disease duration did not significantly differ between DE and standard dose cohorts. Almost all people with IBD on DE ustekinumab continued on therapy beyond 12 months (84.5%).
Rates of faecal calprotectin remission (<250ug/g), endoscopic remission and patient reported outcome (PRO2) remission were higher 12 months post DE (Table 1). Systemic steroid requirements fell significantly 12 months post DE. The number of endoscopies and radiological investigations fell at 12 months post DE, while the rates of hospital admissions did not significantly differ between the DE and standard cohorts. Clinical assessments (per person) reduced from 1.2 pre-DE to 0.9 post DE.
Conclusion
In a large real-world Australasian cohort of people receiving ustekinumab for IBD, close to half required DE. DE led to reduced systemic steroid use and improved endoscopic, PRO2 and FCP remission rates at 12 months. These data can be used to perform health economy analysis to determine the price points at which DE is cost effective, with additional data on quality of life and indirect healthcare costs being important to include for a robust holistic assessment of value in care.