Ustekinumab dose escalation improves clinical responses in refractory Crohn’s disease
Syedreza A. Haider, Abhijeet Yadav, Courtney Perry, Leon Su, Olalekan Akanbi, Praneeth Kudaravalli, Nishant Tripathi, Mahmoud Hashim, Mohammed Khalifa Abdelsalam, M. A. Hussein, Ahmed Elkheshen, Vihang Patel, Saad Emhmed Ali, Latoya Lamb, Karen Ingram, Casie Mayne, Amy Stuffelbeam, Deborah Flomenhoft, Arnold J. Stromberg, Terrence A. Barrett
Abstract
BACKGROUND: Clinicians often utilize off-label dose escalation of ustekinumab (UST) in Crohn's disease (CD) patients with disease refractory to standard dosing. Previous studies report mixed results with dose escalation of UST. METHODS: A retrospective observational study of 143 adult patients with CD receiving UST over a 33-month time period was conducted. Patients receiving UST at standard dosage for a minimum of 16 weeks were included in the analysis. Primary outcomes collected were clinical response [Physician Global Assessment Score (PGA) by >1] and remission (PGA = 0). Changes in clinical parameters were calculated for dose-escalated patients beginning with the time of dose switch (~42 weeks) and compared with a group of patients who were classified as "failing" standard dosing at 42 weeks who were not dose escalated. RESULTS: < 0.05). Surprisingly, disease duration and prior CD surgeries inversely correlated with the need for dose escalation. CONCLUSION: Our results support UST Q4 week dose escalation for selected CD patients who fail to achieve remission on standard Q8 week dosing. Dose escalation improves clinical outcomes, prevents worsening disease severity, and positively impacts CRP and albumin levels. Together these data indicate that clinicians should attempt Q4 week UST dosing in refractory CD patients before switching to an alternative class of biologic therapy.