Year 2025 / Volume 117 / Number 5
Original
Analysis of the effectiveness and safety of maintenance treatment with intravenous ustekinumab in inflammatory bowel disease

241-248

DOI: 10.17235/reed.2024.10731/2024

Rubén Pampín Sánchez, Alba Gonzalo González, Santiago Fuertes Camporro, Ane Goenaga Ansola, Andrea Fórneas Sangil, Sonia Tembrás Martínez, Pilar Varela Trastoy, Cristina Martínez-Múgica Barbosa,

Abstract
Background and purpose: ustekinumab is a monoclonal antibody approved for the treatment of moderate to severe Crohn’s disease (CD) and ulcerative colitis (UC). In spite of being an effective treatment, patients may have suboptimal response, or lose it over time. In these cases, ustekinumab intravenous (IV) maintenance therapy has been explored as a rescue option. Methods: retrospective, monocentric, descriptive, observational study that included adult patients with inflammatory bowel disease who received maintenance therapy with intravenous ustekinumab after loss of response to intensified subcutaneous therapy. The primary outcome was a combination of clinical remission with biochemical and/or endoscopic response at week 12 after intravenous intensification. Results: twenty-two patients were included and the primary outcome was achieved in 36.36 % of patients. At week 12, clinical remission was achieved in 40.91 % of patients, and biochemical remission in 63.64 %. The median Harvey-Bradshaw index (HBI) score in patients with CD decreased from 6 to 3 points at week 12 (p < 0.001), and to 2 points at week 52 (p = 0.004). After a median follow-up period of 31.46 months, 81.82 % of patients continued their treatment with ustekinumab. No adverse events were reported. Conclusions: maintenance therapy with intravenous ustekinumab seems to be effective and safe for the rescue of patients with CD and UC who lost response to intensified subcutaneous ustekinumab.
Lay Summary
In spite of the approval of new drugs for the treatment of inflammatory bowel diseases, therapeutic options are still limited. Many patients do not achieve adequate control of their disease with the currently available treatments, which highlights the need to optimize them. This study focused on assessing the efficacy and safety profile of an intensified treatment with intravenous Ustekinumab as maintenance therapy for patients who responded poorly to subcutaneous doses. The outcomes of patients treated with maintenance intravenous Ustekinumab were analyzed, observing their clinical responses and treatment persistence over time. Intensified therapy with intravenous Ustekinumab allowed for a high percentage of patients who did not respond to typical doses to regain response. In our study, 81.82% of patients continued the treatment in the long term. Additionally, blood drug levels were observed to improve, although some statistical analyses showed no statistically significant differences. In conclusion, intensified intravenous Ustekinumab is an effective and safe option for patients who lose response to the subcutaneous form over time. This strategy must be considered before switching to different drugs. Further studies are needed in order to identify which patients benefit the most from this approach, as well as to determine the best dosing regimen.
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Pampín Sánchez R, Gonzalo González A, Fuertes Camporro S, Goenaga Ansola A, Fórneas Sangil A, Tembrás Martínez S, et all. Analysis of the effectiveness and safety of maintenance treatment with intravenous ustekinumab in inflammatory bowel disease. 10731/2024


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Publication history

Received: 20/08/2024

Accepted: 29/10/2024

Online First: 04/12/2024

Published: 08/05/2025

Article revision time: 56 days

Article Online First time: 106 days

Article editing time: 261 days


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