Long-term effectiveness and safety of ustekinumab in Crohn’s disease: a prospective cohort study

Abstract

Background Real-world data showed that ustekinumab is an effective treatment for Crohn's disease for up to 52 weeks. Yet, long-term effectiveness and safety outcomes beyond 52 weeks are limited. This study aimed to evaluate the corticosteroidfree clinical remission for up to 104 weeks. Secondary aims were focused on biochemical disease, dosing adjustments and safety outcomes. Methods This multicentre prospective cohort study enrolled Crohn's disease patients who started ustekinumab between May 2016 and September 2019. Participants had scheduled outpatient visits at week 0, 13, 26, 52 and 104. Data on clinical disease [Harvey Bradshaw Index (HBI) = 4 points = remission], biochemical disease (faecal calprotectin = 200 µg/g or C-reactive protein = 10 mg/l = remission), dose adjustments and adverse drug reactions (ADRs) were recorded. Results We included 101 Crohn's disease patients. In all patients, the proportion of patients in corticosteroid-free clinical remission was 35 and 36% at week 52 and 104. Of patients achieving corticosteroid-free remission at week 52, more than half maintained corticosteroid-free remission throughout week 104. Biochemical remission rates were 25 and 30% at week 52 and 104, respectively. In the first year of treatment, 33% required their first dose escalation, and 15% in the second year. Overall, 7% of patients discontinued ustekinumab due to ADRs. Ustekinumab persistency rates were 68% at week 52 and 59% at week 104. Conclusion Ustekinumab is an effective and well-tolerated treatment for Crohn's disease. More than half of all patients continued ustekinumab treatment after 104 weeks whereas one-third achieved corticosteroid-free remission.

Efficacy, drug sustainability, and safety of ustekinumab treatment in Crohn’s disease patients over three years

“…Recent prospective data of the Dutch ICC (Initiative on Crohn and Colitis) Registry showed UST treatment probability to be at 64.3% at week 52 and 54.8% at week 104, with loss of response to be the main reason for quitting the drug, and no new safety issues 12 . A different Dutch study with partly the same authors as the ICC Registry study found a 59% drug survival probability at week 104 18 . The dose escalation rate was 33% at the end of year 1 and 15% at year 2.…”

“…The few 2-year studies concluded with all-over similar findings to the results we publish here. Recent multicenter prospective data revealed clinical remission rates, as per the HBI, to be at 40.0% at year 1 and 40.4% at year 2, and steroid-free remission rates to be 35% and 35.5%, respectively 18 . The low but still present steroid use observed in our cohort (12.8%, 7.4%, and 5.4%) allows us to believe our steroid-free remission rates correspond to this degree (exact values for this variable of our cohort are not shown here).…”

Meta‐analysis: Persistence of advanced therapies in the treatment of inflammatory bowel disease

“…Among the 63 publications, 10‐72 58 were journal articles and 5 were international conference abstracts. Two conference abstracts 71,72 were replaced by subsequent published articles found in our search.…”

Long-term real-world data of ustekinumab in Crohn’s disease: the Stockholm ustekinumab study

“…A number of studies have utilized real-world data to assess the long-term effectiveness and persistence of ustekinumab maintenance therapy. 28 – 41 However, real-world data of objectively assessed disease activity, such as faecal markers and endoscopic outcomes, are limited. 10 , 18 , 34 , 35 …”