Year 2023 / Volume 115 / Number 12
Original
Effectiveness and safety of ustekinumab dose escalation in Crohn’s disease: a multicenter observational study

686-692

DOI: 10.17235/reed.2023.9402/2022

Raúl Vicente Olmedo Martín, Juan María Vázquez Morón, María del Mar Martín Rodríguez, Marta Lázaro Sáez, Álvaro Hernández Martínez, Federico Argüelles-Arias,

Abstract
Background: ustekinumab has proven effective in Crohn’s disease (CD). However, some patients will partially respond or lose response over time. Data supporting the effectiveness of dose escalation in this scenario is scarce. Aim: to evaluate the effectiveness of ustekinumab dose escalation in CD. Methods: patients with active CD (Harvey-Bradshaw ≥ 5) who had received intravenous (IV) induction and at least a subcutaneous (SC) dose were included in this retrospective observational study. Ustekinumab dose was escalated, either via shortening of the interval to six or four weeks or IV reinduction plus shortening to every four weeks. Results: ninety-one patients were included, and ustekinumab dose was escalated after a median of 35 weeks of treatment. At week 16 after intensification, steroid-free clinical response and remission were observed in 62.6 % and 25.3 % of patients, respectively. Systemic corticosteroids were discontinued in 46.7 % of patients who were on corticosteroids at baseline. Follow-up data beyond week 16 were available for 78 % of patients; at the last visit, 66.2 % and 43.7 % were in steroid-free clinical response and remission, respectively. After a median follow-up of 64 weeks, 81 % of patients were still treated with ustekinumab. Adverse events were reported in 4.3 % of patients; these were all mild and did not lead to hospitalization or discontinuation of treatment. Five patients (5.5 %) underwent surgical resection, with no immediate postsurgical complications. Conclusion: ustekinumab dose escalation was effective in recapturing response in over half of the patients. These findings suggest that dose escalation should be considered in patients who experience loss or partial response to the standard maintenance.
Lay Summary
Crohn's disease is a chronic inflammatory disorder that affects the digestive tract and causes significant impairment in quality of life. The available treatment options are limited and do not work for all patients. In addition, they can lose effectiveness over time, sometimes having to increase the dose or shorten the time between administrations to keep the patient free of symptoms. Ustekinumab is a biologic drug that blocks inflammatory mediators that has demonstrated efficacy in moderate-to-severe Crohn´s disease patients in clinical trials. In these clinical trials, a conventional dose authorized by regulatory agencies was tested. For this reason, given the scarcity of available data, this study aimed to evaluate the intensification of the Ustekinumab dose in a group of patients who either had no response to the drug or lost it to follow-up. To do this, a series of 91 patients from several reference hospitals were included and the symptomatic and analytical response and the durability of the treatment after the dose optimization strategy was analyzed. Almost 2 out of 3 patients responded to dose escalation and that approximately 80% were maintained on treatment beyond a year of starting this strategy. Furthermore, there were no documented security issues. These results encourage further exploration of the best way to optimize treatment with Ustekinumab in patients with Crohn's disease.
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Citation tools
Olmedo Martín R, Vázquez Morón J, Martín Rodríguez M, Lázaro Sáez M, Hernández Martínez Á, Argüelles-Arias F, et all. Effectiveness and safety of ustekinumab dose escalation in Crohn’s disease: a multicenter observational study. 9402/2022


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Publication history

Received: 04/12/2022

Accepted: 31/05/2023

Online First: 14/06/2023

Published: 12/12/2023

Article revision time: 168 days

Article Online First time: 192 days

Article editing time: 373 days


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