P667 USTEkinumAb Double intravenous loading induction therapY at week 0,4 in patients with Crohn’s Disease– results from STEADY study
Chin, A.(1)*;Jeffrey, A.(1);Teh, W.L.(1);Menon, S.(1);So, K.(1);Venugopal, K.(1);Picardo, S.(1);
(1)Royal Perth Hospital, Department of Gastroenterology, Perth, Australia;
Background
Ustekinumab (UST) is a safe and effective therapy for moderate to severe Crohn’s disease (CD). Standard induction therapy involves a single weight-based intravenous dose followed by a subcutaneous dose at week eight. Accelerated or dose intensified induction regimens have been associated with better clinical outcomes for various biologic therapies, however, these have not been investigated in patients commencing UST. UST re-induction has been shown to be effective in recovering response in patients who have previously lost clinical response. We aim to compare clinical outcomes in a group of CD patients who received standard intravenous induction (SII) of UST compared to double intravenous induction (DII).
Methods
A retrospective observational cohort study of all patients that commenced UST, aged ≥ 18 from a single tertiary inflammatory bowel disease (IBD) centre. Patients received either standard IV dosing or double IV dosing (IV dose at week 0 and 4) based on the discretion of the treating physician. Data was collected from a prospectively maintained database between the period October 2015 to October 2022. The primary outcome was clinical remission, defined as Harvey Bradshaw Index (HBI) <5 with scores collected at baseline and at week 52. Patients that discontinued therapy due to a lack or loss of response or progressed to require surgery were considered treatment failures. Two sample t-test was used for comparisons between groups for continuous variable and chi-square for categorical variables.
Results
47 patients were included of which 38 received SII and 9 had DII. There were no significant differences in baseline HBI or previous biologic exposures between groups (Table 1). All 9 patients that received DII were in clinical remission at week 52 compared to 29 out of the 38 that received SII, however, this was not clinically significant (Figure 1; 100% vs 76%, p=0.10). Of the 9 patients, not in clinical remission in the SII group, 5 were due to treatment failures (3 required surgery, 2 switched medical therapy) with the other 4 remaining on UST till week 52 (1 had a clinical response and 3 had no clinical response). There were no safety concerns (serious infections or malignancy) reported in the DII group.
Conclusion
● All Crohn’s patients that commenced double intravenous induction were in clinical remission at week 52.
● A higher proportion of patients that received DII vs SII were in clinical remission at week 52, however this was not statistically significant. Further larger studies and studies with longer duration of follow-up are required to determine a clinical difference.
● Double intravenous induction of UST is a safe and effective option for Crohn’s disease.