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. 2025 Jul 28:18:17562848251358147.
doi: 10.1177/17562848251358147. eCollection 2025.

Monthly intravenous maintenance treatment with ustekinumab regains clinical response in patients with Crohn's disease who no longer respond to the drug when administered subcutaneously

Berta López-Sáez  1   2 , Ariadna Altadill  1   2 , Eduard Brunet-Mas  3 , Belen Garcia-Sagué  1   2 , Luigi Melcarne  1   2 , Laura Patricia Llovet  1   2 , Luis Enrique Frisancho  1   2 , Anna Puy  1   2 , Sergio Lario  1   2   4 , Maria Jose Ramirez-Lazaro  1   2   4 , Jorge Del Estal  5 , Albert Villoria  1   2   4   2 , Xavier Calvet Calvo  1   2   4   2
Affiliations

Monthly intravenous maintenance treatment with ustekinumab regains clinical response in patients with Crohn's disease who no longer respond to the drug when administered subcutaneously

Berta López-Sáez et al. Therap Adv Gastroenterol. .

Abstract

Background: Several studies have assessed the efficacy of re-induction and subcutaneous intensification of ustekinumab (UST) to regain clinical remission of inflammatory bowel disease (IBD). However, very few have evaluated the effectiveness of intravenous UST for this purpose.

Objectives: The aims of the study were to evaluate the efficacy of high-dose intravenous UST (USTiv) for regaining remission in Crohn's Disease (CD) and to assess the safety of the drug.

Design: Observational, retrospective, single-center study.

Methods: All patients who had received intravenous UST to regain remission until June 2023 were included. Clinical response was evaluated using the Harvey-Bradshaw Index. Drug survival was calculated using Kaplan-Meier curves.

Results: Twenty-three patients (52% female, mean age 40.5 ± 13.9) with CD were included. Seven (30%) patients had an incomplete primary response to UST, while 16 (70%) presented a secondary loss of response. Clinical response rates for USTiv administered monthly were 17/23 (73.9%) at week 8, 14/23 (60.9%) at week 16, and 10/12 (83.3%) at 1 year. Clinical remission rates were 11/23 (47.8%), 9/23 (39.1%), and 8/12 (66.7%), respectively. Median drug survival was 15.3 ± 7.7 months. Two patients (8%) experienced recurrent mild respiratory infections. No patients discontinued USTiv due to adverse events.

Conclusion: More than half of the patients with CD who underwent maintenance treatment with USTiv regained clinical response after failing with subcutaneous UST treatment. No significant adverse events were observed.

Keywords: Crohn’s disease; inflammatory bowel disease; ustekinumab.

Plain language summary

An alternative way to use ustekinumab for Crohn’s disease patients who lose response Ustekinumab (UST) is a drug widely used to treat Crohn’s Disease (CD), and it’s commonly administered subcutaneously. However, some patients do not respond well enough or lose the benefits of the treatment over time. In this study, we evaluated whether switching to intravenous UST could help patients regain control of their symptoms. We reviewed data from 23 patients with CD who received this treatment at our hospital. Most had previously responded to subcutaneous UST but later experienced a loss of effectiveness. After switching to intravenous UST, more than half of the patients showed improvement at 8 and 16 weeks, and this response was maintained in many patients after one year. The treatment was generally well tolerated, and no one had to stop it because of side effects. These results suggest that intravenous UST may be a helpful option for patients with CD who no longer respond to the standard treatment.

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Figures

flowchart of study outline
Figure 1.
Flowchart of the study.
Kaplan-Meier curve shows the survival rate of USTiv treatment over 30 months
Figure 2.
Kaplan–Meier USTiv treatment survival over time. USTiv, intravenous ustekinumab.
compare survival curves for ustekinumab or ustc ustekinumab, according to dose, reason for intensification, behavior of disease and extension of disease, showing different time points
Figure 3.
(a) USTiv treatment survival curves over time according to USTsc dose, (b) USTiv treatment survival curves over time according to the reason for intensification, (c) USTiv treatment survival curves over time according to behavior of disease, and (d) USTiv treatment survival curves over time according to the extension of the disease. USTiv, intravenous ustekinumab; USTsc, subcutaneous ustekinumab.
See this image and copyright information in PMC

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