Esophagus to Small Intestine
Clin Gastroenterol Hepatol. 2024;22(1):144–53.e2
Evolution of symptoms after ustekinumab induction therapy in patients with Crohn’s disease
Background and aims: Ustekinumab is an effective treatment of Crohn’s disease (CD). Of interest to patients is knowing how soon symptoms may improve. The authors analyzed ustekinumab response dynamics from the ustekinumab CD trials.
Methods: Patients with CD received intravenous induction with ustekinumab approximately 6 mg/kg (n = 458) or placebo (n = 457). Week-8 ustekinumab responders received subcutaneous ustekinumab 90 mg as the first maintenance dose or as an extended induction dose for non-responders. Patient-reported symptom changes (stool frequency, abdominal pain, general well-being) within the first 14 days and clinical outcomes through week 44 were evaluated using the Crohn’s Disease Activity Index (CDAI).
Results: After ustekinumab infusion, stool frequency improvement was significantly (p < 0.05) greater than placebo on day 1 and for all patient-reported symptoms by day 10. In patients with no history of biologic failure or intolerance, cumulative clinical remission rates increased from 23.0% at week 3 to 55.5% at week 16 after the subcutaneous dose at week 8. Corresponding cumulative rates for patients with a history of biologic failure or intolerance increased from 12.9% to 24.1%. Neither change from baseline in CDAI score nor week-8 ustekinumab pharmacokinetics were associated with week-16 response. Among all patients who received subcutaneous ustekinumab 90 mg every 8 weeks, up to 66.7% were in clinical response at week 44.
Conclusions: Ustekinumab induction provided symptom relief by day 1 post-infusion. Following ustekinumab infusion and a subcutaneous 90 mg injection, clinical outcomes continued to increase through week 16 and up to week 44. Regardless of week 8 clinical status or ustekinumab pharmacokinetics, patients should receive additional treatment at week 8.