Endpoints for extraintestinal manifestations in inflammatory bowel disease trials: the EXTRA consensus from the International Organization for the Study of Inflammatory Bowel Diseases

被引：21

作者：

Guillo, Lucas ^{[1
]}

Abreu, Maria ^{[2
]}

Panaccione, Remo ^{[3
]}

Sandborn, William J. ^{[4
]}

Azevedo, Valderilio F. ^{[5
]}

Gensler, Lianne ^{[7
]}

Moghaddam, Bahar ^{[9
]}

Ahuja, Vineet ^{[12
]}

Ali, Sabrina A. ^{[6
]}

Allez, Matthieu ^{[13
]}

Ananthakrishnan, Ashwin N. ^{[14
,15
]}

Bhattacharya, Abhik ^{[10
]}

Dubinsky, Marla ^{[11
]}

Griffiths, Anne ^{[16
]}

Hart, Ailsa ^{[17
]}

Korelitz, Burton ^{[18
]}

Kotze, Paulo G. ^{[19
]}

Koutroubakis, Iommaso E. ^{[20
]}

Lakatos, Peter L. ^{[21
,22
]}

Lindsay, James O. ^{[23
,24
]}

Magro, Fernando ^{[25
,26
]}

Mantzaris, Gerassimos J. ^{[27
]}

Ng, Slew C. ^{[28
]}

O'Morain, Cohn ^{[29
]}

Panes, Julian ^{[30
]}

Parigi, Tom Maso ^{[31
,32
]}

Ran, Zhihua ^{[33
]}

Rogler, Gerhard ^{[34
]}

Rubin, David T. ^{[35
]}

Sachar, David B. ^{[10
]}

Siegmund, Britta ^{[36
,37
,38
,39
]}

Steinwurz, Flavio ^{[40
]}

Tysk, Curt ^{[41
]}

Vavricka, Stephan ^{[34
]}

Verstraete, Sofa G. ^{[6
]}

Brezin, Antoine P. ^{[42
]}

Haemel, Anna K. ^{[8
]}

Dignass, Axel ^{[43
]}

Sands, Bruce E. ^{[10
]}

Danese, Silvio ^{[31
,32
]}

Peyrin-Biroulet, Laurent ^{[44
,45
]}

机构：

[1] Univ Aix Marseille, Univ Hosp Marseille Nord, Dept Gastroenterol, Marseille, France

[2] Univ Miami, Miller Sch Med, Div Gastroenterol, Miami, FL 33136 USA

[3] Univ Calgary, Dept Med, Div Gastroenterol & Hepatol, Calgary, AB, Canada

[4] Univ Calif San Diego, Div Gastroenterol, La Jolla, CA 92093 USA

[5] Fed Univ Paran, Internal Med Dept, Rheumatol Unit, Curitiba, Parana, Brazil

[6] Univ Calif San Francisco, Dept Pediat, UCSF Benioff Childrens Hosp San Francisco, San Francisco, CA USA

[7] Univ Calif San Francisco, Dept Med Rheumatol, San Francisco, CA 94143 USA

[8] Univ Calif San Francisco, Dept Dermatol, San Francisco, CA USA

[9] Icahn Sch Med Mt Sinai, Dept Med, Div Rheumatol, New York, NY 10029 USA

[10] Icahn Sch Med Mt Sinai, Dr Henry J Janowitz Div Gastroenterol, New York, NY 10029 USA

[11] Icahn Sch Med Mt Sinai, Susan & Leonard Feinstein Inflammatory Bowel Dis, Div Pediat Gastroenterol & Nutr, New York, NY 10029 USA

[12] All India Inst Med Sci, Dept Gastroenterol, New Delhi, India

[13] Univ Paris, Hop St Louis, AP HP, Serv Gastroenterol, Paris, France

[14] Massachusetts Gen Hosp, Div Gastroenterol, Boston, MA 02114 USA

[15] Mongan Inst, Clin Translat Epidemiol Unit, Boston, MA USA

[16] Univ Toronto, SickKids Hosp, Div Gastroenterol, Toronto, ON, Canada

[17] Imperial Coll London, Fac Med, Dept Surg & Canc, Div Integrat Syst Med & Digest Dis, London, England

[18] Lenox Hill Hosp, Hofstra Northwell Sch Med, New York, NY USA

[19] Pontificia Univ Catolica Parana, Colorectal Surg Unit, Hlth Sci Postgrad Program, IBD Outpatient Clin, Curitiba, Parana, Brazil

[20] Univ Hosp Heraklion, Dept Gastroenterol, Iraklion, Greece

[21] McGill Univ, Div Gastroenterol, Montreal, PQ, Canada

[22] Semmelweis Univ, Dept Med 1, Budapest, Hungary

[23] Barts & London Queen Marys Sch Med & Dent, Blizard Inst, London, England

[24] Barts Hlth NHS Trust, Dept Gastroenterol, Royal London Hosp, London, England

[25] Univ Porto, Hosp Sao Joao, Inst Pharmacol & Therapeut, Gastroenterol Dept,Fac Med, Porto, Portugal

[26] Univ Porto, MedInUP Ctr Drug Discovery & Innovat Med, Porto, Portugal

[27] GHA Evaggelismos Polyklin, Dept Gastroenterol, Athens, Greece

[28] Chinese Univ Hong Kong, Inst Digest Dis, LKS Inst Hlth Sci, Dept Med & Therapeut,State Key Lab Digest Dis, Hong Kong, Peoples R China

[29] Trinity Coll Dublin, Fac Hlth Sci, Dept Gastroenterol, Dublin, Ireland

[30] CIBERehd, Dept Gastroenterol, IDIBAPS, Hosp Clin Barcelona, Barcelona, Spain

[31] IRCCS Osped San Raffaele, Gastroenterol & Endoscopy, Milan, Italy

[32] Univ Vita Salute San Raffaele, Milan, Italy

[33] Shanghai Jiao Tong Univ, Renji Hosp,Key Lab Gastroenterol & Hepatol, Shanghai Inflammatory Bowel Dis Res Ctr, Sch Med,Minist Hlth,Div Gastroenterol & Hepatol, Shanghai, Peoples R China

[34] Univ Zurich, Univ Hosp Zurich, Dept Gastroenterol & Hepatol, Zurich, Switzerland

[35] Univ Chicago Med, Inflammatory Bowel Dis Ctr, Chicago, IL USA

[36] Chariti Univ Med Berlin, Dept Med Gastroenterol Infect Dis Rheumatol, Berlin, Germany

[37] Free Univ Berlin, Berlin, Germany

[38] Humboldt Univ, Berlin, Germany

[39] Campus Benjamin Franklin, Berlin Inst Hlth, Berlin, Germany

[40] Hosp Israelita Albert Einstein, Div Gastroenterol, Sao Paulo, Brazil

[41] Orebro Univ, Fac Med & Hlth, Dept Gastroenterol, Orebro, Sweden

[42] Univ Paris 05, Hop Cochin, Dept Ophthalmol, Paris, France

[43] Goethe Univ, Agaplesion Markus Hosp, Dept Med 1, Frankfurt, Germany

[44] Univ Lorraine, Univ Hosp Nancy, Dept Gastroenterol, F-54511 Vandoeuvre Les Nancy, France

[45] Univ Lorraine, Univ Hosp Nancy, Inserm NGERE U1256, F-54511 Vandoeuvre Les Nancy, France

来源：

LANCET GASTROENTEROLOGY & HEPATOLOGY | 2022年 / 7卷 / 03期

关键词：

CLASSIFICATION; PSORIASIS; CRITERIA; THERAPY;

D O I：

10.1016/S2468-1253(21)00297-1

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

Extraintestinal manifestations occur frequently in patients with inflammatory bowel disease (IBD) and remain a diagnostic and therapeutic challenge. The aim of the Endpoints for Extraintestinal Manifestations in Inflammatory Bowel Disease Trials (EXTRA) initiative was to achieve international expert consensus on how to assess these manifestations in IBD trials. A systematic literature review was done to identify methods to diagnose extraintestinal manifestations in patients with IBD and measure treatment outcomes. A consensus meeting involving a panel of 41 attendees, including gastroenterologists and referral specialists, was held on March 31, 2021, as part of an International Organization for the Study of Inflammatory Bowel Diseases initiative. The panel agreed that a specialist's expertise is needed to confirm the diagnosis of extraintestinal manifestations before the inclusion of a patient in IBD trials, except for axial spondyloarthritis, for which typical symptoms and MRI can be sufficient. Easy to-measure endpoints were identified to assess the response of extraintestinal manifestations to treatment without needing specialist involvement. For uveitis, peripheral spondyloarthritis, and arthralgia, endpoint measurements need specialist expertise. The timing of endpoint measurements was discussed for individual extraintestinal manifestations. The EXTRA consensus proposes guidelines on how to thoroughly evaluate extraintestinal manifestations within IBD trials, and recommends that these guidelines are implemented in future trials to enable prospective assessment of these manifestations and comparison between studies.

引用

页码：254 / 261

页数：8

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