Real-life efficacy and safety of Ustekinumab as second- or third-line therapy in Crohn’s disease: results from a large Italian cohort study

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

Territorial Gastroenterology Service, ASL BAT, Andria (BT), Italy. antotursi@tiscali.it

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• Pharmacology

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.

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