PMID- 34249147
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231107
IS  - 1756-283X (Print)
IS  - 1756-2848 (Electronic)
IS  - 1756-283X (Linking)
VI  - 14
DP  - 2021
TI  - Switching from Infliximab Originator to SB2 Biosimilar in Inflammatory Bowel 
      Diseases: A Multicentric Prospective Real-Life Study.
PG  - 17562848211023384
LID - 10.1177/17562848211023384 [doi]
LID - 17562848211023384
AB  - BACKGROUND: Current literature still lacks studies evaluating the effectiveness 
      and safety of switching from Infliximab originator to SB2 biosimilar in 
      Inflammatory Bowel Diseases (IBDs). We aimed to verify the ability of SB2 to 
      maintain the clinical and biochemical response induced by originator after 
      switching. As secondary outcome, we aimed to verify safety, tolerability and 
      immunogenicity of SB2 biosimilar compared with its IFX originator. METHODS: We 
      prospectively enrolled all patients who switched from originator to SB2 at three 
      Italian IBD Units from August 2018 to April 2020. We collected clinical and 
      biochemical data at the time of switch (T0), and at the first (T1) and the second 
      (T2) visits after switching (mean time from switching: 135 and 329 days, 
      respectively). In addition, data regarding therapeutic drug monitoring at T0 and 
      T1 were recorded. RESULTS: Eighty-five IBD patients (28 with Ulcerative Colitis 
      and 57 with Crohn's Disease) were included in the study. At T1, we observed 
      statistically significant modifications in clinical activity of disease (70 
      patients were in clinical remission at baseline and 60 at T1 p = 0.02), but not 
      at T2 (p = 0.3). Fecal calprotectin values were not different both at T1 and T2 
      (both p = 0.9) as well as the rate of concomitant treatment with steroids 
      (p = 0.2 and p = 0.1) or immunosuppressants (p = 0.1 and p = 1.0). Moreover, the 
      need for therapeutic optimization from T0 to T1 and from T1 to T2 was found 
      significant (both p = 0.01). No anti-drug antibodies were identified at T1, and 
      no serious adverse events were recorded. CONCLUSIONS: Overall, our data show that 
      most of the patients switching from Infliximab originator to SB2 maintain the 
      clinical and biochemical remission for at least 1 year. Further data are 
      necessary to understand the clinical implications of these findings in the long 
      term.
CI  - (c) The Author(s), 2021.
FAU - Massimi, Davide
AU  - Massimi D
AD  - Division of Gastroenterology, Department of Surgery, Oncology and 
      Gastroenterology, University of Padua, Padua, Italy.
FAU - Barberio, Brigida
AU  - Barberio B
AUID- ORCID: 0000-0002-3164-8243
AD  - Division of Gastroenterology, Department of Surgery, Oncology and 
      Gastroenterology, University of Padua, Padua, Italy.
FAU - Bertani, Lorenzo
AU  - Bertani L
AUID- ORCID: 0000-0001-8653-1790
AD  - Department of Translational Research and New Technologies in Medicine and 
      Surgery, University of Pisa, Pisa, Italy.
FAU - Costa, Francesco
AU  - Costa F
AD  - Department of Translational Research and New Technologies in Medicine and 
      Surgery, University of Pisa, Pisa, Italy.
FAU - Ferronato, Antonio
AU  - Ferronato A
AD  - Endoscopy Unit, Alto Vicentino Hospital, AULSS7 Pedemontana, Italy.
FAU - Facchin, Sonia
AU  - Facchin S
AD  - Division of Gastroenterology, Department of Surgery, Oncology and 
      Gastroenterology, University of Padua, Padua, Italy.
FAU - Cardin, Romilda
AU  - Cardin R
AD  - Division of Gastroenterology, Department of Surgery, Oncology and 
      Gastroenterology, University of Padua, Padua, Italy.
FAU - Cingolani, Linda
AU  - Cingolani L
AD  - Division of Gastroenterology, Department of Surgery, Oncology and 
      Gastroenterology, University of Padua, Padua, Italy.
FAU - Casadei, Cesare
AU  - Casadei C
AD  - Division of Gastroenterology, Department of Surgery, Oncology and 
      Gastroenterology, University of Padua, Padua, Italy.
FAU - D'Inca, Renata
AU  - D'Inca R
AD  - Division of Gastroenterology, Department of Surgery, Oncology and 
      Gastroenterology, University of Padua, Padua, Italy.
FAU - Zingone, Fabiana
AU  - Zingone F
AUID- ORCID: 0000-0003-1133-1502
AD  - Division of Gastroenterology, Department of Surgery, Oncology and 
      Gastroenterology, University of Padua, Via Giustiniani 2, Padua, 35121, Italy.
FAU - Savarino, Edoardo Vincenzo
AU  - Savarino EV
AUID- ORCID: 0000-0002-3187-2894
AD  - Division of Gastroenterology, Department of Surgery, Oncology and 
      Gastroenterology, University of Padua, Padua, Italy.
LA  - eng
PT  - Journal Article
DEP - 20210627
PL  - England
TA  - Therap Adv Gastroenterol
JT  - Therapeutic advances in gastroenterology
JID - 101478893
PMC - PMC8239954
OTO - NOTNLM
OT  - Biosimilar SB2
OT  - Crohn's Disease
OT  - Infliximab
OT  - Ulcerative Colitis
OT  - anti-TNF
COIS- Conflict of interest statement: - Edoardo Vincenzo Savarino served as a speaker, 
      consultant, and advisory board member for AbbVie, MSD, Takeda, Ferring. - Renata 
      D'Inca served as a speaker, consultant, and advisory board member for AbbVie, 
      MSD, Takeda, Ferring. - The other authors have no conflict of interest.
EDAT- 2021/07/13 06:00
MHDA- 2021/07/13 06:01
PMCR- 2021/06/27
CRDT- 2021/07/12 05:49
PHST- 2021/01/06 00:00 [received]
PHST- 2021/05/12 00:00 [accepted]
PHST- 2021/07/12 05:49 [entrez]
PHST- 2021/07/13 06:00 [pubmed]
PHST- 2021/07/13 06:01 [medline]
PHST- 2021/06/27 00:00 [pmc-release]
AID - 10.1177_17562848211023384 [pii]
AID - 10.1177/17562848211023384 [doi]
PST - epublish
SO  - Therap Adv Gastroenterol. 2021 Jun 27;14:17562848211023384. doi: 
      10.1177/17562848211023384. eCollection 2021.