| 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: |
Tursi A.; Mocci G.; Cuomo A.; Allegretta L.; Aragona G.; Colucci R.; Della Valle N.; Ferronato A.; Forti G.; Gaiani F.; Graziani M. G.; Lorenzetti R.; Luzza F.; Paese P.; Penna A.; Pica R.; Piergallini S.; Pranzo G.; Rodino S.; Scarcelli A.; Zampaletta C.; Cicerone C.; Cocco A.; De' Angelis G.; Donnarumma L.; Franceschi M.; Gallina S.; Grasso G.; Larussa T.; Luppino I.; Faggiani R.; Fanigliulo L.; Pagnini C.; Perazzo P.; Sacco R.; Sebkova L.; Scorza S.; Serio M.; De Monti A.; Picchio M.; Elisei W.; Maconi G. |
| Contributors: |
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' Angeli; 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 |
| Publisher Information: |
Verduci Editore s.r.l |
| Publication Year: |
2021 |
| Collection: |
The University of Milan: Archivio Istituzionale della Ricerca (AIR) |
| Subject Terms: |
Adverse event; Anti-TNFα; Clinical remission; Crohn’s disease; Mucosal healing; Ustekinumab; Settore MED/12 - Gastroenterologia |
| 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: |
info:eu-repo/semantics/altIdentifier/pmid/33660823; info:eu-repo/semantics/altIdentifier/wos/WOS:000623975000048; volume:25; issue:4; firstpage:2099; lastpage:2108; numberofpages:10; journal:EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES; https://hdl.handle.net/2434/860330 |
| DOI: |
10.26355/eurrev_202102_25115 |
| Availability: |
https://hdl.handle.net/2434/860330; https://doi.org/10.26355/eurrev_202102_25115 |
| Rights: |
info:eu-repo/semantics/openAccess |
| Accession Number: |
edsbas.5FCA3F2B |
| Database: |
BASE |