| Title: |
Real-life efficacy and safety of Ustekinumab as second- or third-line therapy in Crohn’s disease: results from a large Italian cohort study |
| Authors: |
A. Tursi; G. Mocci; A. Cuomo; L. Allegretta; G. Aragona; R. Colucci; N. Della Valle; A. Ferronato; G. Forti; F. Gaiani; M.G. Graziani; R. Lorenzetti; F. Luzza; P. Paese; A. Penna; R. Pica; S. Piergallini; G. Pranzo; S. Rodino; A. Scarcelli; C. Zampaletta; C. Cicerone; A. Cocco; G. De’ Angelis; L. Donnarumma; M. Franceschi; S. Gallina; G. Grasso; T. Larussa; I. Luppino; R. Faggiani; L. Fanigliulo; C. Pagnini; P. Perazzo; R. Sacco; L. Sebkova; S. Scorza; M. Serio; A. De Monti; M. Picchio; W. Elisei; G. Maconi |
| Source: |
European Review for Medical and Pharmacological Sciences, Vol 25 (2021) |
| Publisher Information: |
Verduci Editore |
| Publication Year: |
2021 |
| Collection: |
Directory of Open Access Journals: DOAJ Articles |
| Subject Terms: |
Therapeutics. Pharmacology; RM1-950 |
| Description: |
OBJECTIVE: Ustekinumab (UST) is an anti-IL12/23 antibody for the treatment of Crohn’s Disease (CD). The aim of this study was to compare the efficacy and safety of UST in a large population-based cohort of CD patients who failed previous treatment with other biologics. PATIENTS AND METHODS: 194 CD patients (108 males and 86 females, mean age 48 years (range 38-58 years) were retrospectively reviewed. 147 patients were already treated with anti-TNFα (75.8%), and 47 (24.2%) patients were already treated with anti-TNFα and vedolizumab. Concomitant treatment with steroids was present in 177 (91.2%) patients. RESULTS: At week 12, clinical remission was achieved in 146 (75.2%) patients. After a mean follow-up of 6 months, clinical remission was maintained in 135 (69.6%) patients; at that time, mucosal healing was assessed in 62 (31.9%) patients, and it was achieved in 33 (53.2) patients. Three (1.5%) patients were submitted to surgery. Steroid-free remission was achieved in 115 (59.3%) patients. Both serum C-Reactive Protein and Fecal Calprotectin (FC) levels were significantly reduced with respect to baseline levels during follow-up. A logistic regression, UST therapy as third-line therapy (after both anti-TNFα and vedolizumab), FC >200 µg/g, and HBI ≥8 were significantly associated with lack of remission. Adverse events occurred in 5 (2.6%) patients, and four of them required suspension of treatment. CONCLUSIONS: UST seemed to be really effective and safe in CD patients unresponsive to other biologic treatments, especially when used as second-line treatment. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
https://www.europeanreview.org/wp/wp-content/uploads/2099-2108-1.pdf; https://doaj.org/toc/1128-3602; https://doaj.org/article/c04ebc74c60c4d3aa72d6daa5872d56e |
| Availability: |
https://doaj.org/article/c04ebc74c60c4d3aa72d6daa5872d56e |
| Accession Number: |
edsbas.8F8AC4F2 |
| Database: |
BASE |