Selecting End Points for Disease-Modification Trials in Inflammatory Bowel Disease: the SPIRIT Consensus From the IOIBD

Berre, Catherine Le; Peyrin–Biroulet, Laurent; Sandborn, William J.; Colombel, Jean–Frédéric; Rubin, David; Chowers, Yehuda; Reinisch, Walter; Schreiber, Stefan; Allez, Matthieu; D’Haens, Geert R.; Ghosh, Subrata; Koutroubakis, Ioannis Ε.; Gibson, Peter R.; Halfvarson, Jonas; Hart, Ailsa; Kaser, Arthur; Munkholm, Pia; Kruis, Wolfgang; Vermeire, Séverine; Loftus, Edward V.; Lukáš, Milan; Mantzaris, Gerassimos J.; O’Moráin, Colm; Panés, Julián; Rogler, Gerhard; Spinelli, Antonino; Sands, Bruce E.; Ananthakrishnan, A; Ng, Siew C.; Sachar, David B.; Travis, Simon; Steinwurz, Flávio; Turner, Dan; Dulai, Parambir S.; Jairath, Vipul; Dotan, Iris; Abreu, María T.; Panaccione, Remo; Danese, Silvio

doi:10.1053/j.gastro.2020.10.065

Cited by 91 publications

(59 citation statements)

References 98 publications

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“…During the last years, the therapeutic targets for IBD are focusing on "target" to treat that target the stage of mucosal healing in intestinal inflammation especially histological healing (88,89). A significant proportion of patients with IBD are resistant to treatment using standard drugs.…”

Section: Use Of Intestinal Flora To Treat Ibdmentioning

confidence: 99%

Gut Microbiota Is a Potential Biomarker in Inflammatory Bowel Disease

Guo

Huang

et al. 2022

Front. Nutr.

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Inflammatory bowel disease (IBD), which includes ulcerative colitis (UC) and Crohn's disease (CD), is characterized by relapse and remission alternately. It remains a great challenge to diagnose and assess disease activity during IBD due to the lack of specific markers. While traditional biomarkers from plasma and stool, such as C-reactive protein (CRP), fecal calprotectin (FC), and S100A12, can be used to measure inflammation, they are not specific to IBD and difficult to determine an effective cut-off value. There is consensus that gut microbiota is crucial for intestinal dysbiosis is closely associated with IBD etiopathology and pathogenesis. Multiple studies have documented differences in the composition of gut microbiota between patients with IBD and healthy individuals, particularly regarding microbial diversity and relative abundance of specific bacteria. Patients with IBD have higher levels of Proteobacteria and lower amounts of Bacteroides, Eubacterium, and Faecalibacterium than healthy individuals. This review summarizes the pros and cons of using traditional and microbiota biomarkers to assess disease severity and treatment outcomes and addresses the possibility of using microbiota-focused interventions during IBD treatment. Understanding the role of microbial biomarkers in the assessment of disease activity and treatment outcomes has the potential to change clinical practice and lead to the development of more personalized therapies.

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Section: Use Of Intestinal Flora To Treat Ibdmentioning

confidence: 99%

Gut Microbiota Is a Potential Biomarker in Inflammatory Bowel Disease

Guo

Huang

et al. 2022

Front. Nutr.

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“…Predictive biomarker studies recruiting IBD patients with heterogeneous phenotypes, are more likely to benefit from a holistic and multi-dimensional assessment of therapy effect, which can be a composite of several unidimensional outcome measures. The recent SPIRIT initiative to establish a consensus on outcome measures for disease modification could serve as a starting point towards an objective, holistic and patient-centered outcome assessment that can be further adapted to serve the aims of biomarker studies ( Le Berre and Peyrin-Biroulet, 2021 ). Alternatively, objectivity in assessing the reliability of discovered biomarkers can be ensured by designing studies including subgroups of patients with homogenous phenotypes, where therapy effect can be adequately assessed in each subgroup using the most suitable simple outcome measure.…”

Section: Introductionmentioning

confidence: 99%

Biomarker discovery for personalized therapy selection in inflammatory bowel diseases: Challenges and promises

Alsoud

Vermeire

Verstockt

2022

Current Research in Pharmacology and Drug Discovery

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The past decades witnessed a significant stride in deciphering the pathophysiology of inflammatory bowel disease, which further advanced drug development adding several new biologicals and small molecules to the arsenal of available therapies. Surprisingly, this wealth in therapeutic options did not yield the aspired high durable response rates. In addition, the increase in therapeutic availabilities ignited an increase in research toward biomarkers that could help assign therapies to patients with the highest probability of response. Luckily, major steps have been undertaken in this domain which resulted in the discovery of some interesting biomarkers that are still under validation. However, the pace in which this domain is progressing, the discordance between short-term endpoints in biomarker discovery studies and the ambition of the disease community in modifying disease course, and the uncertainties about the validity of discovered biomarkers highlight the need for a critical appraisal of research conduct in this domain. In this review, we shed light on areas of improvement in biomarker discovery studies that will help optimize the use of available therapies and break the current therapeutic ceiling.

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“…A continuous upgrade of colorectal disease diagnosis and treatment is mandatory if we want to improve patients' outcomes, and this is not only true when treating a patient with malignant disease but also benign disease. When facing an inflammatory bowel disease (IBD) diagnosis, we can still provide little assurance to patients' questions about their future [3]. How will this affect my life?…”

mentioning

confidence: 99%