P79 A UK-based experience of IV ustekinumab reloading strategy in patients with refractory crohn’s disease given in a tertiary IBD centre

• Published in: Gut Vol. 73; no. Suppl 1; pp. A96 - A97
• Main Authors: Kamarul Bahrin, Muhammad Hafiz, Al-Zarrad, Dania, Alexander, James, Arebi, Naila, Misra, Ravi, Kamperidis, Nikolaos, Hart, Ailsa
• Format: Journal Article
• Language: English
• Published: London BMJ Publishing Group Ltd and British Society of Gastroenterology 01.06.2024; BMJ Publishing Group LTD
• Subjects: Albumin; Body mass index; Crohn's disease; Cytokines; Dosage; Interleukin 12; Interleukin 23; Medical treatment; Monoclonal antibodies; Patients; Phenotypes; Poster Presentations; Remission; Remission (Medicine); Statistical analysis
• ISSN: 0017-5749; 1468-3288
• DOI: 10.1136/gutjnl-2024-BSG.161

IntroductionTreatment of refractory Crohn’s disease (CD) poses a clinical challenge due to its unpredictable course with debilitating symptoms.Ustekinumab is a human monoclonal antibody that acts as a cytokine inhibitor targeting interleukin-12 and interleukin-23, it is considered an effective option to treat CD, although, over time patients can experience loss of response. Various approaches have been adopted to recapture therapeutic response, one of which, is administering a single intravenous (IV) reloading dose (6mg/kg) during its maintenance dosing window.MethodsA retrospective audit reviewing the outcome of adult patients with CD aged ≥ 18 who received a one off IV reloading of Ustekinumab during their maintenance dosing window between January 2019 to May 2023 were included. We evaluated this strategy in inducing and maintaining remission through primary and secondary outcomes as outlined below.Firstly, we analysed the post-IV reloading treatment persistence at 6 months, 12 months and > 12 months, including the average number of months gained on Ustekinumab in each respective group.We defined a clinical response as ≥3 points reduction from the baseline Harvey-Bradshaw Index (HBI), and a clinical remission as HBI Score of ≤4. Biochemical response is defined by > 30% reduction in Faecal Calprotectin (FC) and biochemical remission as FC level of < 250 mg/g. The effect this strategy had on CRP and Albumin level were also investigated.Secondly, we evaluated the role of Body Mass Index (BMI) groups in predicting IV Ustekinumab reloading failure.Results56 patients were included with a mean age of 55.5 years old (95% CI [50.5,60.5]) and the most common CD phenotype being ileocolonic (n=35; 62.5%). (n=39) 70.9% patients achieved treatment persistence post-IV reloading to date, as opposed to (n=12) 21.8% with treatment persistence of less than 12 months. Of particular interest, patients who had biological therapy switch after 12 months (n=4; 7.1%) gained on average an extra 20.5 months (95% CI [23.76, 17.20]) being on Ustekinumab. (n=7) 12.5% had severe CD flare up despite this strategy and required corticosteroid therapy, with (n=3) 5.3% eventually ended up in surgery.This strategy also led to a statistically significant clinical and FC-defined biochemical response and remission but not albumin or CRP, as shown in the table 1 below.Our analysis on the role of BMI in predicting treatment strategy failure did not result in any statistically significant mean difference between low, normal and high BMI groupsAbstract P79 Table 1The outcome of IV ustekinumab reloading on HBI, CRP, Albumin and Fecal Calprotectin levelConclusionIV reloading of Ustekinumab is an effective strategy to recapture response in CD patients who experience secondary loss of response and most patients gained a substantial number of months on Ustekinumab. Of interest, BMI does not play a role in predicting treatment failure. This study opens up more options to optimise CD treatment in those with refractory disease and will be an intriguing subject for a cost-effectiveness analysis.