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

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Extraintestinal manifestations (EIM) of inflammatory bowel disease (IBD) were first described in 1976. 1 The anti-tumour necrosis factors agents signed the emergence of potent systemic treatment in IBD, allowing us to look beyond the gut and effectively treat these manifestations along with the luminal disease. 2 In the early 2000s, a landmark positive randomised controlled trial was conducted with infliximab for pyoderma gangrenosum. 3 A few years later, with the vedolizumab approval, the concept of gut-selectivity raised some concerns about the efficacy of new biologics for EIMs. 4 After a three-step meeting, Falloon et al. 5 proposed some guidance for diagnosis, management and follow-up on five major EIMs: erythema nodosum, pyoderma gangrenosum, uveitis, peripheral arthritis and axial arthritis. 5 This US (United States) consensus involved 12 IBD specialists, four rheumatologists, three ophthalmologists, six dermatologists and four patient representatives. The main strength of

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confidence: 99%

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confidence: 99%

Editorial: shedding new light on extraintestinal manifestations in inflammatory bowel disease

Guillo

Peyrin–Biroulet

Danese

2022

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“…We agree with the EXTRA authors regarding the complimentary but distinct goals of our two initiatives 2,3 . The EXTRA consensus was designed specifically to identify EIM endpoints for use in clinical trials 1 .…”

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confidence: 63%

“…EIMs represent a critically unmet need, with limited data to guide management. The Endpoints for EIMs in IBD Trials (EXTRA) consensus from the International Organization for the Study of Inflammatory Bowel Disease (IOIBD) is thus a welcome and important addition to the EIM literature 2 …”

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confidence: 99%

Editorial: shedding new light on extraintestinal manifestations in inflammatory bowel disease—authors’ reply

Falloon

Cohen

Rieder

2022

“…Of note, in parallel to this consensus panel, the International Organisation for the Study of Inflammatory Bowel Disease (IOIBD) conducted the Endpoints for Extra‐Intestinal Manifestations in Inflammatory Bowel Disease (EXTRA) initiative, which was recently published 32 . This excellent manuscript provides guidance regarding endpoints for clinical trials developed by a panel of 41 international experts.…”

Section: Discussionmentioning

confidence: 99%

A United States expert consensus to standardise definitions, follow‐up, and treatment targets for extra‐intestinal manifestations in inflammatory bowel disease

Falloon

Cohen

Ananthakrishnan

et al. 2022

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Summary Background and aims Extra‐intestinal manifestations (EIMs) are a common complication of inflammatory bowel diseases (IBD), affecting up to half of the patients. Despite their high prevalence, information on standardised definitions, diagnostic strategies, and treatment targets is limited. Methods As a starting point for a national EIM study network, an interdisciplinary expert panel of 12 gastroenterologists, 4 rheumatologists, 3 ophthalmologists, 6 dermatologists, and 4 patient representatives was assembled. Modified Delphi consensus methodology was used. Fifty‐four candidate items were derived from the literature review and expert opinion focusing on five major EIMs (erythema nodosum, pyoderma gangrenosum, uveitis, peripheral arthritis, and axial arthritis) were rated in three voting rounds. Results For use in a clinical practice setting and as part of the creation of a prospective registry of patients with EIMs, the panel developed definitions for erythema nodosum, pyoderma gangrenosum, uveitis, peripheral arthritis, and axial arthritis; identified the appropriate and optimal subspecialists to diagnose and manage each; provided methods to monitor disease course; offered guidance regarding monitoring intervals; and defined resolution and recurrence. Conclusions Consensus criteria for appropriate and optimal means of diagnosing and monitoring five EIMs have been developed as a starting point to inform clinical practice and future trial design. Key findings include straightforward diagnostic criteria, guidance regarding who can appropriately and optimally diagnose each, and monitoring options that include patient and physician‐reported outcomes. These findings will be used in a national multicenter study network to optimise the management of EIMs.