Davide Giuseppe Ribaldone, Elisa Tribocco, Franco Scaldaferri, Marco Murgiano, Simone Parello, Federica Di Vincenzo, Angelo Del Gaudio, Pierluigi Puca, Daniele Napolitano, Alfredo Papa, Loris Riccardo Lopetuso, Lucrezia Laterza, Cristina Bezzio, Alessandro Armuzzi, Valeria Farinola, Edoardo Vincenzo Savarino, Fabiana Zingone, Brigida Barberio, Luisa Bertin, Alessia Todeschini, Angela Variola, Anna Maria Carvalhas Gabrielli, Francesca Ferretti, Rosanna Cannatelli, Antonietta Gerarda Gravina, Raffaele Pellegrino, Anna Viola, Clara De Francesco, Fabrizio Bossa, Luca Pastorelli, Carla Felice, Gabriele Dragoni, Daniele Canova, Linda Cingolani, Rocco Spagnuolo, Maria Maddalena Terpin, Alessandra Zilli, Ambra Magiotta, Francesco Segatta, Simone Saibeni, Ana Juverdeanu, Marta Vernero, Gian Paolo Caviglia
In clinically stable CD, observed 6-month effectiveness and safety after procurement-driven ustekinumab biosimilar switching were similar to continued reference treatment. Longer-term studies, particularly in patients receiving every-4-week dosing, are needed.
BACKGROUND & AIMS: Controlled real-world evidence on nonmedical switching from reference ustekinumab to biosimilars in Crohn's disease (CD) is limited. We compared 6-month outcomes after switching versus continued reference treatment.
METHODS: In this prospective observational cohort at 18 Italian centers, adults with CD in clinical remission (Harvey-Bradshaw Index <5), steroid-free for ≥8 months of reference ustekinumab, underwent a procurement-driven switch to 1 of 3 approved biosimilars or continued reference treatment. The expanded clinical-success endpoint required clinical remission without systemic corticosteroids, anti-interleukin-12/23 discontinuation, inflammatory bowel disease-related hospitalization, or intestinal surgery. The protocol-specified noninferiority margin was -15%.
RESULTS: Among 462 patients, 337 switched and 125 continued reference ustekinumab; only 4 (0.9%) received every-4-week dosing. Expanded clinical success occurred in 306 of 332 switched patients (92.2%) and 114 of 123 controls (92.7%; risk difference, -0.5%, 95% CI -5.9 to 4.9), meeting the noninferiority criterion. Results were consistent for the protocol-defined three-component composite and after propensity-score weighting. Biosimilar persistence was 93.7%; switch-back occurred in 1.2%. Two adverse events were reported after switching.
CONCLUSIONS: In clinically stable CD, observed 6-month effectiveness and safety after procurement-driven ustekinumab biosimilar switching were similar to continued reference treatment. Longer-term studies, particularly in patients receiving every-4-week dosing, are needed.