Generally, in my view, “bad” inflammatory bowel disease (IBD) occurs when treatments are not working; though, many would argue that any IBD is bad IBD. Over the next few days, reviewed articles will focus on the problem of IBD that is not responding well to treatment.
A Yerushalmy-Feler et al. JPGN 2022; 75: 717-723. 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
In this retrospective study with 69 children with Crohn’s disease (CD) from 25 centers, the authors looked at the effectiveness of ustekinumab (UST) dose escalation which entailed reducing frequency to less than every 8 weeks. Most children were biologic (98.6%)- and immunomodulator (86.8%)- experienced.
- Clinical response and remission were observed at 3 months after UST escalation in 46 (67%) and 29 (42%) children, respectively.
- Fecal calprotectin level from 1100 (500–2300) to 515 (250–1469) µg/g (P = 0.012) 3 months post-escalation
- Endoscopic and transmural healing were achieved in 3 of 19 (16%) and 2 of 15 (13%) patients, respectively
In their discussion, the authors note that UST has not received FDA approval despite the fact that it has become a common second- and third-line biologic therapy for pediatric CD.
My take: This study supports the common practice of escalation of UST for children with active CD despite treatment at every 8 weeks.
Related Ustekinumab Studies:
- J Meserve et al. Clin Gastroenterol Hepatol 2022; 20: 2728-2740. Open Access! Effectiveness of Reinduction and/or Dose Escalation of Ustekinumab in Crohn’s Disease: A Systematic Review and Meta-analysis In this article with 15 cohort studies in 925 adults with CD with inadequate response or loss of response to standard dose ustekinumab, on meta-analysis, 55% of patients achieved clinical response [with dose escalation]…61% of patients were able to achieve endoscopic response, including 29% who achieved endoscopic remission. Dose interval shortening alone recaptured response in 57% patients.
- RS Dalal et al. Clin Gastroenterol Hepatol 2022; 20: 2399-2401. Predictors and Outcomes of Ustekinumab Dose Intensification in Ulcerative Colitis: A Multicenter Cohort Study This retrospective study looked at 108 adult patients with UC who had ustekinumab escalation; more than 40% required dose intensification. “Similar to our findings in Crohn’s disease, >50% of dose-intensified patients achieved corticosteroid-free remission….Patients with minimal/no response to induction had lower odds of remission after intensification.”
- S Dansese et al. Clin Gastroenterol Hepatol 2022; 20: 2858-2867. Open Access! Early Symptomatic Improvement After Ustekinumab Therapy in Patients With Ulcerative Colitis: 16-Week Data From the UNIFI Trial This study, a post hoc analysis of UNIFI trial, found that an early (2 week) symptomatic remission with ustekinumab in 20.2% (P = .012) vs placebo (12.9%). The more extensive results reviewed in the article (Figure 2) showed increasing symptomatic remission rates at week 4 (32.9%), week 8 (44.7%), and week 16 (53,1%) with IV dose of 6 mg/kg. The biologic-naive group had higher symptomatic remission rates (69% at week 16).
Related blog posts:
- Head-to-Head (Sort of): Infliximab vs Ustekinumab for Crohn’s Disease
- Ustekinumab Efficacy in Crohn’s Disease With Concurrent Autoimmune Skin Disease
- Dose Escalation of Ustekinumab & Support Tool “Should I Have IBD Surgery?”
- Can You Give Ustekinumab Subcutaneously After IV Reaction?
- IBD Shorts: Ustekinumab in Kids, Subcutaenous Infliximab, Nutrition Highlights
- Ustekinumab vs Adalimumab: Head-to-Head Study
- Ustekinumab in Pediatric Patients and More on VTE Prophylaxis
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