Real‐world short‐term effectiveness of ustekinumab in 305 patients with Crohn’s disease: results from the ENEIDA registry

Abstract

Summary Background There are limited data of ustekinumab administered according to the doses recommended in the UNITI studies. Aim To assess the real‐world, short‐term effectiveness of ustekinumab in refractory Crohn's disease (CD) Methods Multicentre study of CD patients starting ustekinumab after June 2017 at the recommend dose (260, 390 or 520 mg based on weight ~6 mg/kg IV week 0 and 90 mg subcutaneously week 8). Values for Harvey‐Bradshaw Index (HBI), C‐reactive protein (CRP) and faecal calprotectin (FC) were recorded at baseline and at weeks 8 and 14. Demographic and clinical data, previous treatments, AEs and hospitalisations were documented. Possible predictors of clinical remission were examined. Results Three hundred and five patients were analysed (≥2 previous anti‐TNFα therapies 64% and vedolizumab 29%). At baseline, 217 (72%) had an HBI >4 points. Of these, 101 (47%) and 126 (58%) achieved clinical remission at weeks 8 and 14, respectively. FC levels returned to normal (<250 µg/g) in 46% and 54% of the patients at weeks 8 and 14 respectively. CRP returned to normal (<3 mg/L) in the 35% and 41% of the patients at week 8 and 14 respectively. AEs were recorded in 38, and 40 patients were hospitalised. Intolerance to the most recent anti‐TNF agent and fewer previous anti‐TNF agents were associated with clinical remission at week 14. Endoscopic severity was associated with poor response. Conclusion This is the first study to show the real‐world effectiveness and safety of ustekinumab administered according to the recommended induction regimen in a cohort of highly refractory CD patients.

Short and Long-Term Effectiveness of Ustekinumab in Patients with Crohn’s Disease: Real-World Data from a German IBD Cohort

“…Several studies have provided real-world data on the safety and efficacy of UST. Due to its rather recent approval, most studies evaluate short-term effectiveness [7] only, are retrospective, or do not include the intravenous induction regimen [8,9]. Only a few studies provide insight into long-term effectiveness [10,11] or are prospectively conducted [12].…”

Editorial: real‐world short‐term effectiveness of ustekinumab in 305 patients with Crohn’s disease—results from the ENEIDA registry. Authors' reply

“…Finally, the decrease of CRP, FC and HBI were more pronounced after intravenous dosing (week 8) than after subcutaneous dosing (week 14), probably due to a lack of drug dose . A recent study demonstrated an association between increased FC beyond week 8 and unsatisfactory endoscopy outcomes due to lower levels of ustekinumab .…”

“…We appreciate Drs. Frasca and Cheifetz’ editorial on our recent paper . Due to the recent approval of ustekinumab, there are few studies about its real‐world effectiveness in Crohn's disease (CD) patients treated with recommended doses.…”

“…Since symptoms are very subjective, we defined active disease with Harvey‐Bradshaw index (HBI) and/or objective evidence of active CD with endoscopic activity, C‐reactive protein (CRP) and faecal calprotectin (FC). Since the recently approval of ustekinumab in Spain, we analysed short‐term effectiveness in order to continue the analysis after the one year of approval …”

Editorial: real‐world short‐term effectiveness of ustekinumab in 305 patients with Crohn’s disease—results from the ENEIDA registry

“…Iborra et al assessed the short‐term effectiveness of ustekinumab in 305 patients with Crohn's disease. The information was obtained from the ENEIDA database .…”