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

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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
Pediatric Drugs ( IF 3.7 ) Pub Date : 2021-12-16 , DOI: 10.1007/s40272-021-00486-8
Valeria Dipasquale ₁ , Massimo Martinelli ₂ , Marina Aloi ₃ , Salvatore Accomando ₄ , Patrizia Alvisi ₅ , Serena Arrigo ₆ , Claudia Banzato ₇ , Matteo Bramuzzo ₈ , Mara Cananzi ₉ , Mara Corpino ₁₀ , Clelia Di Mari ₁₁ , Giovanni Di Nardo ₁₂ , Anna Dilillo ₁₃ , Natale Dodaro ₁₄ , Enrico Felici ₁₅ , Simona Gatti ₁₆ , Francesco Graziano ₁₇ , Maria Teresa Illiceto ₁₈ , Lorenzo Norsa ₁₉ , Anna Opramolla ₂₀ , Maria Pastore ₂₁ , Paolo Maria Pavanello ₂₂ , Erminia Romeo ₂₃ , Luca Scarallo ₂₄ , Caterina Strisciuglio ₂₅ , Giovanna Zuin ₂₆ , Claudio Romano ₁

Affiliation

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.
Department of Translational Medical Science, Section of Pediatrics, University of Naples "Federico II", Naples, Italy.
Pediatric Gastroenterology Unit, Department of Maternal and Child Health, Sapienza University-Umberto I Hospital, Rome, Italy.
Pediatrics Operative Unit, Promise Department, University of Palermo, Palermo, Italy.
Pediatric Gastroenterology Unit, Maggiore Hospital, Bologna, Italy.
Unit of Pediatric Gastroenterology and Endoscopy, IRCCS "Giannina Gaslini" Children's Hospital, Genoa, Italy.
Pediatric Clinic, Department of Surgical Sciences, Dentistry, Gynecology and Pediatrics, University Hospital of Verona, Verona, Italy.
Institute for Maternal and Child Health, IRCCS "Burlo Garofolo", Trieste, Italy.
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.
Pediatric Gastroenterology Unit, Pediatric Clinic, Microcitemico Hospital, AOB, Cagliari, Italy.
Pediatric Clinic, V. Buzzi Children's Hospital, University of Milan, Milan, Italy.
Pediatric Gastroenterology and Endoscopy Unit, NESMOS Department, Faculty School of Medicine and Psychology, Sapienza University of Rome, Sant'Andrea University Hospital, Rome, Italy.
Maternal and Child Health Department, Sapienza-University of Rome, Santa Maria Goretti Hospital, Polo Pontino, Latina, Italy.
Pediatric Unit, Hospital of Cosenza, Cosenza, Italy.
Pediatric and Pediatric Emergency Unit, "U. Bosio, Center for Digestive Diseases, Children's Hospital, AO SS Antonio e Biagio e C. Arrigo, Alessandria, Italy.
Department of Pediatrics, G. Salesi Children's Hospital, Ancona, Italy.
Pediatric Unit, Villa Sofia Cervello Hospital, Palermo, Italy.
Pediatric Gastroenterology and Endoscopic Unit, Department of Pediatrics, Santo Spirito" Hospital, Pescara, Italy.
Pediatric Gastroenterology and Transplantation, Papa Giovanni XXIII Hospital, Bergamo, Italy.
Pediatric Gastroenterology Unit, Regina Margherita Children's Hospital, Turin, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza, University of Turin, Turin, Italy.
Division of Pediatrics, IRCCS-Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy.
Department of Pediatrics, Regional Hospital Ca' Foncello, Treviso, Italy.
Digestive Surgery and Endoscopy Unit, Bambino Gesù Children's Hospital, Rome, Italy.
Unit of Gastroenterology and Nutrition, Meyer Children's Hospital, Florence, Italy.
Department of Woman, Child and General and Specialistic Surgery, Luigi Vanvitelli" University of Campania, Naples, Italy.
Pediatric Department, University of Milano Bicocca, Fondazione MBBM, San Gerardo Hospital, Monza, Italy.

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.

中文翻译：

生物仿制药在小儿炎症性肠病中的实际应用：代表 SIGENP IBD 工作组的全国网络调查

客观的

目的是评估意大利儿科胃肠病学、肝病学和营养学会 (SIGENP) 成员对生物仿制药在炎症性肠病 (IBD) 中的认识和实际使用情况。

方法

在 2020 年 7 月 1 日至 12 月 1 日期间，对所有可开生物仿制药的 SIGENP IBD 单位进行了一项匿名网络调查。问卷包括 18 个问题，涉及儿科 IBD 中生物仿制药最相关的方面，即优势、劣势、成本、可追溯性、一般知识和实际使用。对反应进行了描述性分析。

结果

来自意大利北部、中心和南部的 26 个儿科 IBD 单位做出了回应。大多数参与者 ( n = 20) 花费了超过 10 年的时间来照顾儿科 IBD 患者，并在一个拥有 100 至 500 名注册的儿科 IBD 患者 ( n = 14) 的中心工作。大多数参与者 ( n = 18) 报告说他们知道生物仿制药与原研药具有相似的疗效和安全性，并且都认为节约成本是生物仿制药的主要优势。大多数受访者 ( n = 20) 报告说，他们在日常临床实践中从原研药转向生物仿制药，主要是在维持阶段。大多数受访者（n= 20) 没有记录到急性不良事件。几乎所有参与者都对使用生物仿制药感到完全或非常有信心。