Abstract

Effectiveness and Safety of Nonmedical Switch From Adalimumab Originator to SB5 Biosimilar in Patients With Inflammatory Bowel Diseases: Twelve-Month Follow-Up From the TABLET Registry

Inflamm Bowel Dis. 2021 Feb 11;izab027. doi: 10.1093/ibd/izab027. Online ahead of print.

Gherardo Tapete 1 2, Lorenzo Bertani 1 2, Alberto Pieraccini 3, Erica Nicola Lynch 3, Martina Giannotta 4, Riccardo Morganti 5, Ivano Biviano 6, Sara Naldini 7, Maria Gloria Mumolo 1, Francesca De Nigris 4, Francesca Calella 8, Siro Bagnoli 3, Moira Minciotti 9, Simona Maltinti 2, Silvia Rentini 6, Linda Ceccarelli 1, Paolo Lionetti 7, Monica Milla 3, Francesco Costa 1

 
     

Author information

  • 1Department of General Surgery-Gastrointestinal Unit, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.
  • 2Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
  • 3IBD Referral Center, Gastroenterology Clinic, Careggi University Hospital, Florence, Italy.
  • 4S.O.C. Gastroenterologia ed Endoscopia Digestiva-Usl Toscana Centro, Ospedale S. Giovanni di Dio, Florence, Italy.
  • 5Section of Statistics, University Hospital of Pisa, Pisa, Italy.
  • 6A.O.U.S.-U.O.C. Gastroenterologia ed Endoscopia Operativa, Siena, Italy.
  • 7Pediatric Hospital Meyer, University of Florence, Florence, Italy.
  • 8U.O.C. Gastroenterologia-Azienda USL Empoli-Ospedale San Giuseppe, Empoli, Italy.
  • 9SSD Endoscopia Digestiva-Ospedale Apuane-ASL Nordovest, Massa, Italy.

Abstract

Background: Few data are currently available about SB5 in inflammatory bowel diseases (IBD). The aim of this study was to assess the effectiveness and safety of SB5 in a cohort of patients with IBD in stable remission switched from the adalimumab (ADA) originator and in a cohort of patients with IBD naïve to ADA.

Methods: We prospectively enrolled patients with IBD who started ADA treatment with SB5 (naïve cohort) and those who underwent a nonmedical switch from the ADA originator to SB5 (switching cohort). Clinical remission and safety were assessed at baseline and at 3, 6, and 12 months. In addition, in a small cohort of patients who were switched, we assessed the ADA serum trough levels and antidrug antibodies at baseline, 3, and 6 months.

Results: In the naïve cohort, the overall remission rate at 12 months was 60.42%, whereas in the switching cohort it was 89.02%. Fifty-three (36.3%) patients experienced an adverse event, and injection site pain was the most common; it was significantly more frequent in the switching cohort (P = 0.001). No differences were found in terms of ADA serum trough levels at baseline, 3, and 6 months after switching. No patient developed antidrug antibodies after the switch.

Conclusions: We found that SB5 seemed effective and safe in IBD, both in the naïve cohort and in the switching cohort. Further studies are needed to confirm these data in terms of mucosal healing.

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