Ustekinumab for Crohn’s disease: a nationwide real-life cohort study from Finland (FINUSTE)

Abstract

Background: Ustekinumab (UST), a human anti-IL12/23p40 monoclonal antibody, has been approved for treatment of Crohn's Disease (CD) since the end of 2016. This nationwide noninterventional, retrospective chart review explored real-life data in patients receiving UST to provide guidance in UST treatment in the era of increasing prevalence of CD. Methods: The study assessed UST treatment patterns such as dosing frequency, concomitant medication and persistence in 48 CD patients commencing UST therapy in 12 Finnish hospitals during 2017. Clinical remission and response rates were explored using a modified Harvey-Bradshaw index (mHBI) and endoscopic response via the simple endoscopic score for Crohn's disease (SES-CD) as proportions of patients at week 16 and at the end of follow-up. Results: Forty patients (83%) continued UST-treatment at the end of follow-up. At week 16, clinical response and endoscopic healing was observed, where data were available; mHBI decreased from 9 to 3 (p ¼ .0001) and SES-CD from 12 to 3 (p ¼ .009). Clinical benefit was achieved by 83% (19/23) at week 16 and by 76% (16/21) at the end of follow-up. The proportion of patients using corticosteroids decreased from 48% to 25% at week 16 and to 13% at the end of the follow-up. Conclusion: UST showed to be effective and persistent, inducing short-term clinical benefit and endoscopic response in this real-life nationwide study of CD patients. Significant corticosteroid tapering in patients with highly treatment refractory and long-standing CD was observed.

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

“…Our study has shown better outcomes than the UNITI trial, reflecting other real‐world studies . In contrast to UNITI studies, and similar to most published studies, we used HBI because the variables associated with this index are easier to collect retrospectively from the clinical history …”

“…A range of studies from other European groups have analysed short‐ and long‐term effectiveness in large cohorts of CD patients . All published works include refractory CD patients with prior failure of immunosuppressant, anti‐TNF and anti‐integrin therapies.…”

“…We did not describe endoscopic changes at week 14, as we believe that this would have been too early to show significant changes. However, two new studies have analysed endoscopic remission at weeks 16 and 24 . The SES‐CD decreased in both during follow‐up.…”

Real‐world long‐term effectiveness of ustekinumab in Crohn's disease: results from the ENEIDA registry

“…6 The AEs were similar in patients who received ustekinumab and placebo, and the effect was not associated with the dose after 2 and 3 years of treatment. 7,9 There are few data from daily clinical practice on the long-term safety and effectiveness profile of ustekinumab [10][11][12][13][14][15] administered according to an induction regimen in which the initial dose is IV (6 mg/kg at baseline), the first induction dose is SC (90 mg at week 8), and the maintenance dose is SC at 90 mg every 8 or 12 weeks, as recommended in the UNITI studies. 6 Although these studies confirm the effectiveness and safety of ustekinumab in CD patients refractory to many treatments, the number of patients analysed in the long-term follow-up is small, many data are unavailable, and the predictors of clinical response require further investigation.…”

“…6 Although these studies confirm the effectiveness and safety of ustekinumab in CD patients refractory to many treatments, the number of patients analysed in the long-term follow-up is small, many data are unavailable, and the predictors of clinical response require further investigation. [10][11][12][13][14][15] Our group published data on the real-word short-term effectiveness of ustekinumab at weeks 8 and 14 after induction in 305 patients with active CD from the ENEIDA database (CROHNUSK Study). 16 At week 14, clinical remission, normalisation of faecal calprotectin (FC) and normalisation of C-reactive protein (CRP) were achieved in 58%, 54% and 41% of patients respectively.…”