Comprehensive Review of Ustekinumab Utilization in Inflammatory Bowel Diseases: Insights from the ClinicalTrials.gov Registry

Nasser M Alorfi,1 Mansour M Alourfi,2,3 Ghfran Abdulrahman Bokhari,3 Abdullah Alkhattabi,3 Nihal Abdalla Ibrahim,4 Abdulmalik Mohammed Alsabban,5 Mohammad J Almatrafi,5 Yaser Abdulaziz Zakri,5 Abdullah Jasem Almahmoud,6 Khalid Mohammed A Al-ghamdi,6 Saeed Nasser Alsharif7 1Department of Pharmacology and Toxicology, College of Pharmacy, Umm Al-Qura University, Makkah, Saudi Arabia; 2Internal Medicine Department, King Faisal Medical City for Southern Region, Abha, Saudi Arabia; 3Department of Gastroenterology, East Jeddah Hospital, Jeddah, Saudi Arabia; 4College of Pharmacy, Ajman University, Ajman, United Arab Emirates; 5Gastroenterology Section, Department of Medicine, King Abdulaziz Medical City, Jeddah, Saudi Arabia; 6Gastroenterology Section, Internal Medicine Department, King Fahad Hospital, Jeddah, Saudi Arabia; 7Gastroenterology Department, Armed Force Hospital of Southern Region, Khamis Mushait, Saudi ArabiaCorrespondence: Nasser M Alorfi, Department of Pharmacology and Toxicology, College of Pharmacy, Umm Al-Qura University, Makkah, Saudi Arabia, Email Nmorfi@uqu.edu.saBackground: Inflammatory bowel diseases (IBD), including Crohn’s disease and ulcerative colitis, are chronic inflammatory conditions affecting the gastrointestinal tract. To achieve and sustain remission, effective treatment strategies are necessary. Ustekinumab, a biologic agent targeting interleukin-12 and interleukin-23, has emerged as a significant therapeutic option for moderate to severe IBD.Aim: To gain insights into the utilization of Ustekinumab for IBD, we conducted a comprehensive review of the ClinicalTrials.gov registry.Methods: A comprehensive search of the ClinicalTrials.gov was conducted to find all clinical trials involving the use of Ustekinumab in IBD patients. As of December 30th, 2022, 69 clinical trials were identified that included IBD and Ustekinumab. The study list was saved, and those clinical trials that fitted the definition of targeted therapy were included in the review.Results: The results showed that Ustekinumab was associated with significant improvements in the clinical response and remission rates, in both Crohn’s disease and ulcerative colitis patients. Additionally, the safety profile of Ustekinumab was generally favourable, with low rates of adverse events reported. In terms of study design, most of the relevant studies found in the database were interventional studies. The investigation focused on completed studies and found that there were a limited number of clinical trials with interventional measures.Conclusion: Ustekinumab appears to be a promising treatment option for patients with IBD, with the potential to provide significant clinical benefits and a favourable safety profile. Further research is warranted to confirm these findings and explore optimal dosing and treatment regimens.Keywords: ustekinumab, pharmacology, biologics, IBD, clinical trials, gastroenterology