A Single Center Experience With Long-Term Ustekinumab Use and Reinduction in Patients With Refractory Crohn Disease

Abstract

Background Ustekinumab was approved for moderate and severe Crohn’s disease (CD) in 2016, but little is known about long-term outcomes. Methods A retrospective study evaluated all patients with CD treated with ustekinumab, including patients with reinduction. C-reactive protein (CRP), Harvey-Bradshaw Index (HBI), Short Inflammatory Bowel Disease (SIBDQ), and endoscopy outcomes were collected prospectively. Results Ninety-six patients received ustekinumab, resulting in improvement in CRP, HBI, and SIBDQ scores with 68% endoscopic improvement/remission. Thirty-four patients underwent reinduction, resulting in improved HBI and CRP. Conclusions Ustekinumab in refractory CD results in significant clinical and endoscopic improvement and reinduction may be a viable option to recapture response.

How to Optimize Treatment With Ustekinumab in Inflammatory Bowel Disease: Lessons Learned From Clinical Trials and Real-World Data

“…At week 16, 51, and 39% of patients achieved clinical response and remission, respectively ( 101 ). The possibility of re-induction with 6 mg/kg iv UST has been evaluated in other cohorts ( 42 , 102 ). Re-induction has shown to induce a significant decrease in C-reactive protein levels, with endoscopic remission in 25% of patients ( 42 ).…”

“…The possibility of re-induction with 6 mg/kg iv UST has been evaluated in other cohorts ( 42 , 102 ). Re-induction has shown to induce a significant decrease in C-reactive protein levels, with endoscopic remission in 25% of patients ( 42 ). Patients already being intensified to 4-weekly dosing can also benefit from iv re-induction, with approximately half of patients (53%) achieving clinical remission and 67% response ( 99 ).…”

Effectiveness of ustekinumab in patients with refractory Crohn’s disease: a multicentre real-life study in Italy

“…These data are consistent with those of other real-world reports on ustekinumab-treated patients with refractory CD and arthralgia. 16 , 18 , 22 , 25 However, unlike in several other CD cohorts on ustekinumab, 16 , 18 , 19 , 22 , 31 no de novo cases of arthralgia were recorded in our cohort; yet, the patients in our study were not routinely evaluated by a rheumatologist.…”

“…The study also has some limitations that should be considered when interpreting the findings. First, similar to other real-world studies that have investigated the effectiveness and safety of ustekinumab in patients with refractory CD, 13 – 17 , 19 , 20 , 22 , 23 , 25 , 28 , 30 our study had a retrospective design, which could have led to overestimation of the positive response rate and underestimation of AEs, especially of the mild intensity. Second, all patients were treated at tertiary referral centres providing care for patients with IBD.…”

“…Several real-world studies have confirmed the effectiveness and safety of ustekinumab in patients with CD after failure of or intolerance to anti-TNF-α therapy. 13 – 31 However, very few data concerning the Italian real-life experience using ustekinumab for the treatment of CD have been reported. 22 , 24 Moreover, because of the relatively recent regulatory approval of ustekinumab, some studies either did not include the intravenous (IV) induction regimen or evaluated patients for short periods of time.…”