Use of Biosimilars in Pediatric Inflammatory Bowel Disease: An Updated Position Statement of the Pediatric IBD Porto Group of ESPGHAN

被引：38

作者：

de Ridder, Lissy ^{[1
]}

Assa, Amit ^{[2
,3
]}

Bronsky, Jiri ^{[4
]}

Romano, Claudio ^{[5
]}

Russell, Richard K. ^{[6
]}

Afzal, Nadeem A. ^{[7
]}

Hauer, Almuthe C. ^{[8
]}

Knafelz, Daniela ^{[9
]}

Lionetti, Paolo ^{[10
]}

Strisciuglio, Caterina ^{[11
]}

Veres, Gabor ^{[12
]}

Winter, Harland ^{[13
]}

Wolters, Victorien M. ^{[14
]}

Sladek, Malgorzata ^{[15
]}

Vulto, Arnold G. ^{[16
]}

Dias, Jorge A. ^{[17
,18
]}

机构：

[1] Erasmus MC, Sophia Childrens Hosp, Rotterdam, Netherlands

[2] Schneider Childrens Hosp, Petah Tiqwa, Israel

[3] Tel Aviv Univ, Sackler Fac Med, Tel Aviv, Israel

[4] Univ Hosp Motol, Dept Paediat, Prague, Czech Republic

[5] Univ Messina, Pediat Gastroenterol & Cyst Fibrosis Unit, Messina, Italy

[6] Royal Hosp Children, Glasgow, Lanark, Scotland

[7] Southampton Childrens Hosp, Dept Paediat, Tremona Rd, Southampton, Hants, England

[8] Med Univ Graz, GPGE Educ Ctr Paediat Gastroenterol, Dept Paediat & Adolescence Med, Graz, Austria

[9] Bambino Gesu Children Hosp, Hepatol Gasroenterol & Nutr Unit, Rome, Italy

[10] Univ Florence, Meyer Hosp, Dept Neurosci Psychol Pharmacol & Childs Hlth, Florence, Italy

[11] Univ Campania Luigi Vanvitelli, Dept Woman Child & Gen & Specialist Surg, Naples, Italy

[12] Univ Debrecen, Inst Pediat, Debrecen, Hungary

[13] Harvard Med Sch, MassGeneral Hosp Children, Boston, MA 02115 USA

[14] Univ Med Ctr Utrecht, Wilhelmina Childrens Hosp, Dept Paediat Gastroenterol, Utrecht, Netherlands

[15] Jagiellonian Univ, Coll Med, Dept Paediat Gastroenterol & Nutr, Krakow, Poland

[16] Erasmus MC, Hosp Pharm, Rotterdam, Netherlands

[17] Katholieke Univ Leuven, Dept Pharmaceut & Pharmacol Sci, Leuven, Belgium

[18] Hosp Sao Joao, Dept Paediat, Pediat Gastroenterol, Porto, Portugal

来源：

JOURNAL OF PEDIATRIC GASTROENTEROLOGY AND NUTRITION | 2019年 / 68卷 / 01期

关键词：

biologics; biosimilars; Crohn disease; inflammatory bowel disease; pediatric; ulcerative colitis; SHOW IDENTICAL REACTIVITY; CT-P13 INDUCTION THERAPY; LONG-TERM EFFICACY; DOUBLE-BLIND; CROHNS-DISEASE; RHEUMATOID-ARTHRITIS; INFLIXIMAB CT-P13; CLINICAL-OUTCOMES; PARALLEL-GROUP; INDICATION EXTRAPOLATION;

D O I：

10.1097/MPG.0000000000002141

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

Biologic therapies have changed the outcome of both adult and pediatric patients with Inflammatory Bowel Disease (IBD). In September 2013, the first biosimilar of infliximab was introduced into the pharmaceutical market. In 2015, a first position paper on the use of biosimilars in pediatric IBD was published by the ESPGHAN IBD Porto group. Since then, more data have accumulated for both adults and children demonstrating biosimilars are an effective and safe alternative to the originator. In this updated position statement, we summarize current evidence and provide joint consensus statements regarding the recommended practice of biosimilar use in children with IBD.

引用

页码：144 / 153

页数：10

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