The following is a summary of “Safety and Potential Efficacy of Escalating Dose of Ustekinumab in Pediatric Crohn Disease (the Speed-up Study): A Multicenter Study from the Pediatric IBD Porto Group of ESPGHAN” published in the December 2022 issue of Gastroenterology by Yerushalmy-Feler et al.
Although there were no data for children, increasing the maintenance dosage of ustekinumab (UST) proved successful in treating adults with Crohn’s disease (CD). For a study, researchers assessed the efficacy and security of UST dosage escalation in pediatric CD.
The IBD Interest and Porto groups of ESPGHAN affiliated with 25 institutions for the retrospective multicenter investigation. They included kids with CD who started UST at a regular dose and either had their doses increased to intervals shorter than 8 weeks or had their UST reintroduced because their condition was active. Up to 12 months of follow-up, demographic, clinical, laboratory, endoscopic, imaging, and safety data were gathered.
The median illness duration was 4.3 years (2.9–6.3) in the 69 children enrolled (median age 15.8 years, interquartile range 13.8-16.9). The majority of kids had experience with biologics (98.6%) and immunomodulators (86.8%). At 3 months following the UST increase, clinical response and remission were seen in 46 (67%) and 29 (42%) children, respectively. A Lower Weighted Pediatric Crohn’s Disease Activity Index (wPCDAI) at escalation was the best indicator of clinical remission (P = 0.001). Three months after the increase, the median C-reactive protein level dropped from 14 (3-28.03) to 5 (1.1-20.5) mg/L (P = 0.012), and the amount of fecal calprotectin from 1,100 (500-2300) to 515 (250-1469) µg/g (P = 0.012). Three of the 19 (16%) and 2 of the 15 (13%) patients experienced endoscopic and transmural healing, respectively. Due to active illness, 13 patients (18.8%) stopped their therapy. There were no documented severe negative events.
Children with active CD in the middle two-thirds responded to UST dose escalation. After UST dose escalation, milder disease activity may indicate a favorable outcome.
Reference: journals.lww.com/jpgn/Abstract/2022/12000/Safety_and_Potential_Efficacy_of_Escalating_Dose.8.aspx
