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Real-Life Use of Biosimilars in Pediatric Inflammatory Bowel Disease: A Nation-Wide Web Survey on Behalf of the SIGENP IBD Working Group

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Abstract

Objective

The aim was to assess the awareness and real-life use of biosimilars in inflammatory bowel disease (IBD) among the members of the Italian Society of Pediatric Gastroenterology, Hepatology and Nutrition (SIGENP).

Methods

An anonymous web survey involving all SIGENP IBD units which can prescribe biosimilars was conducted between July 1st and December 1st, 2020. The questionnaire included 18 questions addressing the most relevant aspects of biosimilars in pediatric IBD, i.e., advantages, disadvantages, costs, traceability, general knowledge, and real-life use. A descriptive analysis of responses was performed.

Results

Responses came from 26 pediatric IBD units in Italy, with representation of the North, the Center, and the South of Italy. The majority of participants (n = 20) had spent > 10 years caring for pediatric IBD patients, and worked in a center which had between 100 and 500 registered pediatric IBD patients (n = 14). Most participants (n = 18) reported they were aware that biosimilars have similar efficacy and safety to those of the originator, and all regarded cost-sparing as the main advantage of biosimilars. Most respondents (n = 20) reported they switch from originator to biosimilar in their everyday clinical practice, mostly during the maintenance phase. Most respondents (n = 20) registered no acute adverse events. Nearly all participants felt totally or very confident in using biosimilars.

Conclusions

A few years after the introduction of the first biosimilar into the market, real-life data coming from the major IBD units in Italy confirm a favorable and confident position on the use of biosimilars in pediatric IBD.

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References

  1. Danese S, Fiorino G, Michetti P. Viewpoint: knowledge and viewpoints on biosimilar monoclonal antibodies among members of the European Crohn’s and Colitis Organization. J Crohns Colitis. 2014;8:1548–50.

    Article  Google Scholar 

  2. Danese S, Fiorino G, Michetti P. Changes in biosimilar knowledge among European Crohn’s Colitis Organization [ECCO] Members: an updated survey. J Crohns Colitis. 2016;10:1362–5.

    Article  Google Scholar 

  3. de Ridder L, Assa A, Bronsky J, et al. Use of biosimilars in pediatric inflammatory bowel disease: an updated position statement of the Pediatric IBD Porto Group of ESPGHAN. J Pediatr Gastroenterol Nutr. 2019;68:144–53.

    Article  Google Scholar 

  4. Dipasquale V, Romano C. Biosimilar infliximab in paediatric inflammatory bowel disease: Efficacy, immunogenicity and safety. J Clin Pharm Ther. 2020;45:1228–34.

    Article  CAS  Google Scholar 

  5. Park SK, Moon W, Kim ES, et al. Knowledge and viewpoints on biosimilar monoclonal antibodies among Asian physicians: comparison with European physicians. Korean J Gastroenterol. 2019;74:333–40.

    Article  Google Scholar 

  6. Danese S, Gomollon F. ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). J Crohns Colitis. 2013;7:586–9.

    Article  Google Scholar 

  7. Fiorino G, Girolomoni G, Lapadula G, et al. The use of biosimilars in immune-mediated disease: a joint Italian Society of Rheumatology (SIR), Italian Society of Dermatology (SIDeMaST), and Italian Group of Inflammatory Bowel Disease (IG-IBD) position paper. Autoimmun Rev. 2014;13:751–5.

    Article  Google Scholar 

  8. Annese V, Vecchi M. Use of biosimilars in inflammatory bowel disease: statements of the Italian Group for Inflammatory Bowel Disease. Dig Liver Dis. 2014;46:963–8.

    Article  Google Scholar 

  9. Raffaelli EA, Massimino F. Biosimilars: considerations in light of the Italian legal framework. Generics Biosimilars Initiative J (GaBI Journal). 2019;8:5–23.

    Article  Google Scholar 

  10. Sieczkowska J, Jarzębicka D, Banaszkiewicz A, et al. Switching between infliximab originator and biosimilar in paediatric patients with inflammatory bowel disease. Preliminary observations. J Crohns Colitis. 2016;10:127–32.

    Article  CAS  Google Scholar 

  11. Gervais L, McLean LL, Wilson ML, et al. Switching from originator to biosimilar infliximab in paediatric inflammatory bowel disease is feasible and uneventful. J Pediatr Gastroenterol Nutr. 2018;67:745–8.

    Article  CAS  Google Scholar 

  12. van Hoeve K, Dreesen E, Hoffman I, et al. Efficacy, pharmacokinetics, and immunogenicity is not affected by switching from infliximab originator to a biosimilar in pediatric patients with inflammatory bowel disease. Ther Drug Monit. 2019;41:317–24.

    Article  Google Scholar 

  13. Kang B, Lee Y, Lee K, et al. Long-term outcomes after switching to CT-P13 in pediatric-onset inflammatory bowel disease: a single-center prospective observational study. Inflamm Bowel Dis. 2018;24:607–16.

    Article  Google Scholar 

  14. Richmond L, Curtis L, Garrick V, et al. Biosimilar infliximab use in paediatric IBD. Arch Dis Child. 2018;103:89–91.

    Article  Google Scholar 

Download references

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Authors and Affiliations

  1. Pediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human Pathology in Adulthood and Childhood “G. Barresi”, G. Martino University Hospital, University of Messina, Via Consolare Valeria, 98124, Messina, Italy

    Valeria Dipasquale & Claudio Romano

  2. Department of Translational Medical Science, Section of Pediatrics, University of Naples “Federico II”, Naples, Italy

    Massimo Martinelli

  3. Pediatric Gastroenterology Unit, Department of Maternal and Child Health, Sapienza University-Umberto I Hospital, Rome, Italy

    Marina Aloi

  4. Pediatrics Operative Unit, Promise Department, University of Palermo, Palermo, Italy

    Salvatore Accomando

  5. Pediatric Gastroenterology Unit, Maggiore Hospital, Bologna, Italy

    Patrizia Alvisi

  6. Unit of Pediatric Gastroenterology and Endoscopy, IRCCS “Giannina Gaslini” Children’s Hospital, Genoa, Italy

    Serena Arrigo

  7. Pediatric Clinic, Department of Surgical Sciences, Dentistry, Gynecology and Pediatrics, University Hospital of Verona, Verona, Italy

    Claudia Banzato

  8. Institute for Maternal and Child Health, IRCCS “Burlo Garofolo”, Trieste, Italy

    Matteo Bramuzzo

  9. Pediatric Gastroenterology, Unit of Digestive Endoscopy, Hepatology and Care of the Child with Liver Transplantation, Department for Women’s and Children’s Health, University Hospital of Padova, Padua, Italy

    Mara Cananzi

  10. Pediatric Gastroenterology Unit, Pediatric Clinic, Microcitemico Hospital, AOB, Cagliari, Italy

    Mara Corpino

  11. Pediatric Clinic, V. Buzzi Children’s Hospital, University of Milan, Milan, Italy

    Clelia Di Mari

  12. Pediatric Gastroenterology and Endoscopy Unit, NESMOS Department, Faculty School of Medicine and Psychology, Sapienza University of Rome, Sant’Andrea University Hospital, Rome, Italy

    Giovanni Di Nardo

  13. Maternal and Child Health Department, Sapienza-University of Rome, Santa Maria Goretti Hospital, Polo Pontino, Latina, Italy

    Anna Dilillo

  14. Pediatric Unit, Hospital of Cosenza, Cosenza, Italy

    Natale Dodaro

  15. Pediatric and Pediatric Emergency Unit, “U. Bosio, Center for Digestive Diseases, Children’s Hospital, AO SS Antonio e Biagio e C. Arrigo, Alessandria, Italy

    Enrico Felici

  16. Department of Pediatrics, G. Salesi Children’s Hospital, Ancona, Italy

    Simona Gatti

  17. Pediatric Unit, Villa Sofia Cervello Hospital, Palermo, Italy

    Francesco Graziano

  18. Pediatric Gastroenterology and Endoscopic Unit, Department of Pediatrics, Santo Spirito” Hospital, Pescara, Italy

    Maria Teresa Illiceto

  19. Pediatric Gastroenterology and Transplantation, Papa Giovanni XXIII Hospital, Bergamo, Italy

    Lorenzo Norsa

  20. Pediatric Gastroenterology Unit, Regina Margherita Children’s Hospital, Turin, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza, University of Turin, Turin, Italy

    Anna Opramolla

  21. Division of Pediatrics, IRCCS-Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy

    Maria Pastore

  22. Department of Pediatrics, Regional Hospital Ca’ Foncello, Treviso, Italy

    Paolo Maria Pavanello

  23. Digestive Surgery and Endoscopy Unit, Bambino Gesù Children’s Hospital, Rome, Italy

    Erminia Romeo

  24. Unit of Gastroenterology and Nutrition, Meyer Children’s Hospital, Florence, Italy

    Luca Scarallo

  25. Department of Woman, Child and General and Specialistic Surgery, Luigi Vanvitelli” University of Campania, Naples, Italy

    Caterina Strisciuglio

  26. Pediatric Department, University of Milano Bicocca, Fondazione MBBM, San Gerardo Hospital, Monza, Italy

    Giovanna Zuin

Authors
  1. Valeria Dipasquale
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  2. Massimo Martinelli
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  3. Marina Aloi
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  4. Salvatore Accomando
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  5. Patrizia Alvisi
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  6. Serena Arrigo
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  7. Claudia Banzato
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  8. Matteo Bramuzzo
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  9. Mara Cananzi
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  10. Mara Corpino
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  11. Clelia Di Mari
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  12. Giovanni Di Nardo
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  13. Anna Dilillo
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  14. Natale Dodaro
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  15. Enrico Felici
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  16. Simona Gatti
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  17. Francesco Graziano
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  18. Maria Teresa Illiceto
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  19. Lorenzo Norsa
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  20. Anna Opramolla
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  21. Maria Pastore
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  22. Paolo Maria Pavanello
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  23. Erminia Romeo
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  24. Luca Scarallo
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  25. Caterina Strisciuglio
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  26. Giovanna Zuin
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  27. Claudio Romano
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Corresponding author

Correspondence to Claudio Romano.

Ethics declarations

Funding

None.

Conflict of interest

The authors declare no competing interests.

Ethics approval

Not applicable.

Consent to participate

Not applicable.

Consent for publication

Not applicable.

Availability of data and materials

The data that support the findings of this study are available on request from the corresponding author.

Code availability

Not applicable.

Author contributions

V. Dipasquale and C. Romano planned the study; V. Dipasquale, M. Martinelli, M. Aloi, and C. Romano designed the web-based questionnaire; V. Dipasquale, M. Martinelli, M. Aloi, S. Accomando, P. Alvisi, S. Arrigo, C. Banzato, M. Bramuzzo, M. Cananzi, M. Corpino, C. Di Mari, G. Di Nardo, A. Dilillo, N. Dodaro, E. Felici, S. Gatti, F. Graziano, M.T. Illiceto, L. Norsa, A. Opramolla, M. Pastore, P.M. Pavanello, E. Romeo, L. Scarallo, C. Strisciuglio, and G. Zuin collected and interpreted the data; V. Dipasquale and C. Romano drafted the manuscript. All authors made substantial contributions and approved the final version of the manuscript.

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Dipasquale, V., Martinelli, M., Aloi, M. et al. Real-Life Use of Biosimilars in Pediatric Inflammatory Bowel Disease: A Nation-Wide Web Survey on Behalf of the SIGENP IBD Working Group. Pediatr Drugs 24, 57–62 (2022). https://doi.org/10.1007/s40272-021-00486-8

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  • DOI: https://doi.org/10.1007/s40272-021-00486-8

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