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Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease (BioIBD)

Primary Purpose

Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis

Status
Recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab
Sponsored by
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring inflammatory bowel diseases, Crohn Disease, Ulcerative Colitis, Infliximab, Adalimumab, Golimumab, Vedolizumab, Ustekinumab, Anti-TNF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Group 1: Patients with IBD

Inclusion Criteria:

  • Over 18 years.
  • Diagnosis of IBD according to the criteria of the European Crohns and Colitis Organization (ECCO).
  • Have indication of treatment with a biologic drug.
  • Be the first received biologic drug with a given mechanism of action (anti-TNFα, anti-α4β7 or anti-p40).
  • Have endoscopic activity of IBD within 1 month of starting the biologic treatment (see definitions section: SES-CD ≥ 3 in CD and endoscopic sub-index of May ≥ 2 in UC).
  • In the case of CD, receive the biologic treatment by luminal activity (not perianal).
  • Previous treatments (including corticosteroids and immunosuppressants) are allowed provided that they have been stable for the last 3 months prior to beginning treatment with biologics and that they are maintained at a stable dose for the duration of the study.

Exclusion Criteria:

  • Under 18 years old.
  • Having an immune-mediated disease other than IBD at the baseline visit.
  • Having a neoplasm or an active infection at the time of the baseline visit.
  • Pregnancy or lactation.
  • Alcohol or drug abuse.
  • Ostomy.
  • Abdominal surgery in the last 6 months.
  • Colectomy in patients with UC.
  • Active infection with hepatitis B, C or HIV virus.
  • Indication of biologic treatment for a cause other than IBD.
  • Indication of biologic treatment to prevent postoperative recurrence in CD.
  • Have previously received a biologic drug with the same mechanism of action of the drug indicated by your doctor (anti-TNFα, anti-α4β7 or anti-p40).
  • Refusal to give consent for participation in the study.

Group 2: patients without IBD

Inclusion Criteria:

- Patients not diagnosed with IBD, or other inflammatory, allergic, malignant or autoimmune diseases, where a ileocolonoscopy is performed due to the normal clinical practice.

Exclusion Criteria:

  • Under 18 years old.
  • Advanced chronic disease or any other pathology that prevents the follow-up of the protocol of this study.
  • Pregnancy or lactation.
  • Active infection with hepatitis B, C or HIV virus.
  • Alcohol or drug abuse.
  • Finding of macroscopic alterations during the ileocolonoscopy, or finding of relevant inflammatory alterations in the biopsies obtained during the ileocolonoscopy.
  • Treatment with immunomodulators, immunosuppressants, corticosteroids or other drugs that alter the immune system.
  • Refusal to give consent for participation in the study.

Sites / Locations

  • Hospital Universitario Central de AsturiasRecruiting
  • Hospital Universitario Parc TaulíRecruiting
  • Hospital Universitario Marqués de ValdecillaRecruiting
  • Hospital Público General de TomellosoRecruiting
  • Hospital Clínico de SantiagoRecruiting
  • Hospital Universitario de FuenlabradaRecruiting
  • Hospital Universitario de TorrejónRecruiting
  • Hospital de GaldakaoRecruiting
  • Hospital General Universitario de AlicanteRecruiting
  • Hospital Universitario Reina SofíaRecruiting
  • Hospital Universitario DonostiaRecruiting
  • Hospital Universitario Dr. Josep Trueta
  • Hospital Juan Ramón JiménezRecruiting
  • Hospital San JorgeRecruiting
  • Hospital Universitario de La PrincesaRecruiting
  • Hospital Universitario La PazRecruiting
  • Hospital Universitario Virgen del RocíoRecruiting
  • Hospital Universitario y Politécnico La Fe
  • Hospital Rio HortegaRecruiting
  • Hospital Clínico Universitario de ValladolidRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Patients with treatment

healthy control

Arm Description

Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use) per clinical practice, or adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus) per clinical practice, or golimumab (subcutaneus 50 mg milligram(s)-subcutaneus) per clinical practice, or vedolizumab (infusion 300 mg milligram(s)) per clinical practice or ustekinumab (subcutaneous 90 mg milligram(s)-subcutaneus) per clinical practice

Outcomes

Primary Outcome Measures

Identify predictive tissue and blood biomarkers for response to biologic therapies in Crohn´s disease and ulcerative colitis
will be calculated for each of the selected biomarkers: sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio and negative likelihood ratio

Secondary Outcome Measures

Identify non-invasive blood biomarkers of endoscopical inflammation
will be calculated for each of the selected biomarkers: sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio and negative likelihood ratio
Evaluate the effect of the treatment on the immune subsets and study the signaling pathways specifically modulated
To achieve this outcome will be used endoscopic response defined in CD patients as a decrease of 50% in SES-CD(78) 14 weeks after starting treatment and defined in UC patients as a decrease ≥1 point in the mayo score (82) 14 weeks after starting treatment
Generate a collection of biological simple (Blood sample, urine sample, stool sample, biopsy simple)
these samples will be use to reach the outcomes of this study and will be used in future studies

Full Information

First Posted
March 4, 2019
Last Updated
September 22, 2023
Sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
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1. Study Identification

Unique Protocol Identification Number
NCT03885713
Brief Title
Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease
Acronym
BioIBD
Official Title
Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease by Proteomic and Mass Cytometry Approaches
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 10, 2019 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Prospective, multicentre trial which the biologic treatment will be initiated by clinical indication. The treatment selection anti-TNFα (infliximab, adalimumab or golimumab), vedolizumab and ustekinumab will be made at the discretion of the clinician. There will be no random assignment of treatment. The drugs will be used in the approved indications and conditions of use.
Detailed Description
Background IBD, including CD and UC, is a chronic disorder of unknown etiology that involves a pathological response of the immune system, resulting in chronic inflammation of the gastrointestinal tract. IBD generally affects young patients, being a highly disabling disease. Unfortunately IBD has no current treatment, so the therapeutic goal is to keep the inflammatory process under control in order to prevent the onset of symptoms and the development of further complications. The complexity and costs associated with the treatment of IBD make it a very relevant disease. Specifically in the USA, where it is one of the five diseases with the greatest social burden, with an annual cost of 1,700 million dollars for health services. In Europe, the annual costs (direct and indirect) associated with IBD exceed 25,000 million euros. Together, this highlights the strategic importance of IBD for society, including both patients and the health system. IBD prevalence is high, affecting more than 1.6 million inhabitants in the US and more than 2.2 million in Europe. On the other hand, its incidence varies widely depending on the different countries. Nevertheless, in a generalized manner, it is increasing rapidly, probably due to the "westernization" of lifestyles. Indeed, a large multicenter study leaded by the host institution suggests that the current incidence is greater than previously described. In addition, the cost associated with IBD diagnosis and treatment is increasing over time, either because of the costs associated with the treatment itself or due to the greater complexity of the diagnostic tests and tools to which these patients are subjected. Despite the increasingly frequent use of immunosuppressant drugs, the need for surgery due to IBD has not changed substantially in recent decades. It has been suggested that early initiation of treatment with immunosuppressants and biologics to induce remission would prevent the onset of complications of the disease. However, this widely applied strategy would lead to overtreatment of patients who would have had a benign course of the disease. On the other hand, the current treatment strategy is similar in almost all patients with IBD: it starts, in general, with the less aggressive drugs, progressively moving to more potent therapies when previous treatments have failed. In this way, the window of opportunity to prevent complications in more complex patients is often lost. Thus, because there are no prognostic factors that have proven useful in clinical practice, the selection of a treatment for each patient remains empirical, adapted according to clinical evolution and difficulties of each case. Anti-TNFα drugs have been shown to be effective for induction of remission and maintenance thereof in patients with IBD. In 2014, the use of vedolizumab was approved, both for CD and UC, whose therapeutic targets are α4β7 integrins. In 2016, ustekinumab, directed against the p40 subunit shared by interleukins 12 and 23, was approved in patients with CD, thus increasing the therapeutic arsenal against IBD. All these biologic drugs have a high cost, so they pose a great economic burden for health systems. However, approximately only one third of patients will achieve remission. At present, the medical community does not have reliable criteria for selecting which patients will benefit from any of the above-mentioned drugs. Thus, the variables (epidemiological, clinical, analytical, etc.) usually used to predict patients' response to biological therapy have shown little utility. Therefore, it is a priority in the study of IBD the identification of those molecular and cellular pathways involved in the onset of IBD in each patient, in order to make a more rational use of resources. Achieving that goal will allow us to indicate the most appropriate treatment to each individual, hence avoiding administering drugs to patients who will not respond (which implies an inadequate use of resources and an unjustified risk of adverse effects). The identification of biomarkers with capacity to predict clinical response to biologic drugs is, therefore, an area of great interest. In this context, "omic" techniques allow massive searches at various levels, including DNA (genomics) and its modifications (epigenome), RNA (transcriptome), proteins (proteome), bacterial composition (microbiome), etc. This project aims to deepen this aspect through the use of 2 massive last-generation approaches that will identify the signaling routes (proteomics) and the immune cell subsets (mass cytometry) involved in the response to biologic drugs. This will ultimately lead to the identification, in an unbiased manner, of novel predictive biomarkers for response to biologic therapies in IBD. Study population Group 1: Patients with IBD that will start treatment with a biologic drug according to medical criteria in the context of the usual clinical practice. Group 2: Individuals without IBD in whom an ileocolonoscopy is performed and is normal. Definitions Endoscopic activity: In patients with CD, it will be evaluated using the Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD); Endoscopic activity will be considered when the SES-CD is ≥3. In operated patients, or in those where the endoscopic exploration is incomplete, the SES-CD will be calculated according to the explorable segments, considering the previously described activity criterion. In patients with UC, it will be evaluated by the Mayo endoscopic sub-score; endoscopic activity will be considered as ≥2. The assessment of endoscopic activity will be carried out centrally by sending anonymized endoscopic images. Endoscopic response (main endpoint): In patients with CD, the endoscopic response will be defined as a >50% decrease in the SES-CD14 weeks after starting the biologic treatment. As a secondary variable, endoscopic response will be also defined as a decrease ≥3 points in the SES-CD (considered as a clinically significant endoscopic improvement). There is consensus that the evaluation of the response to treatment (and therefore the consideration of a patient as a primary non-responder) should not be performed before week 12-14 (in patients treated with anti-TNFα drugs). In patients with UC, the endoscopic response will be defined as a decrease of ≥1 point in the Mayo endoscopic sub-score 14 weeks after starting the biologic treatment. Endoscopic remission: In patients with CD, endoscopic remission will be defined as a SES-CD ≤2, 14 weeks after starting the biologic treatment. In patients with UC, endoscopic remission will be defined as an endoscopic subscript ≤1, 14 weeks after starting the biologic treatment. Clinical activity: In patients with CD, it will be evaluated using the Crohn's Disease Activity Index (CDAI). Clinical remission will be considered as a CDAI <150 points 14 weeks after starting the biologic treatment; and clinical response, reduction of CDAI by 100 (R-100) or 70 points (R-70). In patients with UC it will be evaluated by the partial Mayo index. Clinical remission will be considered as a partial Mayo index ≤2, with all the scores (of the partial index) of 1 as a maximum and with a sub-score of rectal bleeding of 0, 14 weeks after starting the biologic treatment; and clinical response, the decrease of 3 or more points (of the partial index) with respect to the baseline situation. Sample size The sample size for the laboratory analyses will be 30 in each of the subgroups of patients: 1) CD treated with anti-TNFα drugs; 2) CD treated with vedolizumab; 3) CD treated with ustekinumab; 4) UC treated with anti-TNFα; 5) UC treated with vedolizumab. Since the total number of patients is 150, the inclusion for each of the 17 participating centers will be approximately 9 patients, a perfectly viable figure in the allocated timeframe. It is estimated that the percentage of endoscopic response (primary endpoint) is 30% so in each subgroup there will be 10 responding patients and 20 patients with treatment failure, an adequate number for the evaluation of biomarkers predictors of response. In addition, 30 healthy controls will be included to compare the obtained results in the IBD patients. Development of the study The present study is organized in 3 visits: visit 1, prior to initiating the treatment; visit 2, at 14 weeks after starting treatment; and visit end of study. The investigators will use their proved expertise in previous clinical trials to coordinate and monitor all the research centers using the online AEG-RedCap platform. Data collection forms will be provided to all the centers prior to start the study. The overall duration of the study is estimated at 3 years (20 months of inclusion + 4 months of follow-up + 12 months for analysis).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
Keywords
inflammatory bowel diseases, Crohn Disease, Ulcerative Colitis, Infliximab, Adalimumab, Golimumab, Vedolizumab, Ustekinumab, Anti-TNF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with treatment
Arm Type
Active Comparator
Arm Description
Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use) per clinical practice, or adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus) per clinical practice, or golimumab (subcutaneus 50 mg milligram(s)-subcutaneus) per clinical practice, or vedolizumab (infusion 300 mg milligram(s)) per clinical practice or ustekinumab (subcutaneous 90 mg milligram(s)-subcutaneus) per clinical practice
Arm Title
healthy control
Arm Type
No Intervention
Intervention Type
Biological
Intervention Name(s)
Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab
Intervention Description
Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use) per clinical practice or adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus) per clinical practice or golimumab (subcutaneus 50 mg milligram(s)-subcutaneus) per clinical practice or vedolizumab (infusion 300 mg milligram(s)) per clinical practice or ustekinumab (subcutaneous 90 mg milligram(s)-subcutaneus) per clinical practice
Primary Outcome Measure Information:
Title
Identify predictive tissue and blood biomarkers for response to biologic therapies in Crohn´s disease and ulcerative colitis
Description
will be calculated for each of the selected biomarkers: sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio and negative likelihood ratio
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Identify non-invasive blood biomarkers of endoscopical inflammation
Description
will be calculated for each of the selected biomarkers: sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio and negative likelihood ratio
Time Frame
14 weeks
Title
Evaluate the effect of the treatment on the immune subsets and study the signaling pathways specifically modulated
Description
To achieve this outcome will be used endoscopic response defined in CD patients as a decrease of 50% in SES-CD(78) 14 weeks after starting treatment and defined in UC patients as a decrease ≥1 point in the mayo score (82) 14 weeks after starting treatment
Time Frame
14 weeks
Title
Generate a collection of biological simple (Blood sample, urine sample, stool sample, biopsy simple)
Description
these samples will be use to reach the outcomes of this study and will be used in future studies
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Group 1: Patients with IBD Inclusion Criteria: Over 18 years. Diagnosis of IBD according to the criteria of the European Crohns and Colitis Organization (ECCO). Have indication of treatment with a biologic drug. Be the first received biologic drug with a given mechanism of action (anti-TNFα, anti-α4β7 or anti-p40). Have endoscopic activity of IBD within 1 month of starting the biologic treatment (see definitions section: SES-CD ≥ 3 in CD and endoscopic sub-index of May ≥ 2 in UC). In the case of CD, receive the biologic treatment by luminal activity (not perianal). Previous treatments (including corticosteroids and immunosuppressants) are allowed provided that they have been stable for the last 3 months prior to beginning treatment with biologics and that they are maintained at a stable dose for the duration of the study. Exclusion Criteria: Under 18 years old. Having an immune-mediated disease other than IBD at the baseline visit. Having a neoplasm or an active infection at the time of the baseline visit. Pregnancy or lactation. Alcohol or drug abuse. Ostomy. Abdominal surgery in the last 6 months. Colectomy in patients with UC. Active infection with hepatitis B, C or HIV virus. Indication of biologic treatment for a cause other than IBD. Indication of biologic treatment to prevent postoperative recurrence in CD. Have previously received a biologic drug with the same mechanism of action of the drug indicated by your doctor (anti-TNFα, anti-α4β7 or anti-p40). Refusal to give consent for participation in the study. Group 2: patients without IBD Inclusion Criteria: - Patients not diagnosed with IBD, or other inflammatory, allergic, malignant or autoimmune diseases, where a ileocolonoscopy is performed due to the normal clinical practice. Exclusion Criteria: Under 18 years old. Advanced chronic disease or any other pathology that prevents the follow-up of the protocol of this study. Pregnancy or lactation. Active infection with hepatitis B, C or HIV virus. Alcohol or drug abuse. Finding of macroscopic alterations during the ileocolonoscopy, or finding of relevant inflammatory alterations in the biopsies obtained during the ileocolonoscopy. Treatment with immunomodulators, immunosuppressants, corticosteroids or other drugs that alter the immune system. Refusal to give consent for participation in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Acosta
Phone
913093911
Email
diana.acosta.hlp@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Garre
Email
anagarre.laprincesa@gmail.com
Facility Information:
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabino Riestra
Facility Name
Hospital Universitario Parc Taulí
City
Sabadell
State/Province
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier Calvet
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
State/Province
Cantabria
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Montserrat Rivero
Facility Name
Hospital Público General de Tomelloso
City
Tomelloso
State/Province
Ciudad Real
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfredo Lucendo
Facility Name
Hospital Clínico de Santiago
City
Santiago De Compostela
State/Province
La Coruña
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Barreiro
Facility Name
Hospital Universitario de Fuenlabrada
City
Fuenlabrada
State/Province
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Bermejo
Facility Name
Hospital Universitario de Torrejón
City
Torrejón De Ardoz
State/Province
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Van Domselaar
Facility Name
Hospital de Galdakao
City
Galdakao
State/Province
Vizcaya
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iago Rodríguez
Facility Name
Hospital General Universitario de Alicante
City
Alicante
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Gutiérrez
Facility Name
Hospital Universitario Reina Sofía
City
Córdoba
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Iglesias
Facility Name
Hospital Universitario Donostia
City
Donostia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Bujanda
Facility Name
Hospital Universitario Dr. Josep Trueta
City
Gerona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier Aldeguer
Facility Name
Hospital Juan Ramón Jiménez
City
Huelva
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Héctor Pallarés
Facility Name
Hospital San Jorge
City
Huesca
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Montoro
Facility Name
Hospital Universitario de La Princesa
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier P. Gisbert
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Dolores Martín
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Leo
Facility Name
Hospital Universitario y Politécnico La Fe
City
Valencia
Country
Spain
Individual Site Status
Suspended
Facility Name
Hospital Rio Hortega
City
Valladolid
ZIP/Postal Code
47012
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesus Barrio
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Fernández

12. IPD Sharing Statement

Citations:
PubMed Identifier
15168363
Citation
Loftus EV Jr. Clinical epidemiology of inflammatory bowel disease: Incidence, prevalence, and environmental influences. Gastroenterology. 2004 May;126(6):1504-17. doi: 10.1053/j.gastro.2004.01.063.
Results Reference
background
PubMed Identifier
24833941
Citation
M'Koma AE. Inflammatory bowel disease: an expanding global health problem. Clin Med Insights Gastroenterol. 2013 Aug 14;6:33-47. doi: 10.4137/CGast.S12731. eCollection 2013.
Results Reference
background
PubMed Identifier
29050646
Citation
Ng SC, Shi HY, Hamidi N, Underwood FE, Tang W, Benchimol EI, Panaccione R, Ghosh S, Wu JCY, Chan FKL, Sung JJY, Kaplan GG. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet. 2017 Dec 23;390(10114):2769-2778. doi: 10.1016/S0140-6736(17)32448-0. Epub 2017 Oct 16. Erratum In: Lancet. 2020 Oct 3;396(10256):e56.
Results Reference
background
PubMed Identifier
26129692
Citation
Niewiadomski O, Studd C, Hair C, Wilson J, McNeill J, Knight R, Prewett E, Dabkowski P, Dowling D, Alexander S, Allen B, Tacey M, Connell W, Desmond P, Bell S. Health Care Cost Analysis in a Population-based Inception Cohort of Inflammatory Bowel Disease Patients in the First Year of Diagnosis. J Crohns Colitis. 2015 Nov;9(11):988-96. doi: 10.1093/ecco-jcc/jjv117. Epub 2015 Jun 30.
Results Reference
background
PubMed Identifier
17382602
Citation
Bewtra M, Su C, Lewis JD. Trends in hospitalization rates for inflammatory bowel disease in the United States. Clin Gastroenterol Hepatol. 2007 May;5(5):597-601. doi: 10.1016/j.cgh.2007.01.015. Epub 2007 Mar 26.
Results Reference
background
PubMed Identifier
20393175
Citation
Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D'Haens G, Diamond RH, Broussard DL, Tang KL, van der Woude CJ, Rutgeerts P; SONIC Study Group. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med. 2010 Apr 15;362(15):1383-95. doi: 10.1056/NEJMoa0904492.
Results Reference
background
PubMed Identifier
27002797
Citation
Gisbert JP, Marin AC, Chaparro M. The Risk of Relapse after Anti-TNF Discontinuation in Inflammatory Bowel Disease: Systematic Review and Meta-Analysis. Am J Gastroenterol. 2016 May;111(5):632-47. doi: 10.1038/ajg.2016.54. Epub 2016 Mar 22.
Results Reference
background
PubMed Identifier
25619903
Citation
Gisbert JP, Domenech E. [Vedolizumab in the treatment of Crohn's disease]. Gastroenterol Hepatol. 2015 May;38(5):338-48. doi: 10.1016/j.gastrohep.2014.12.003. Epub 2015 Jan 23. Spanish.
Results Reference
background
PubMed Identifier
26948838
Citation
Domenech E, Gisbert JP. Efficacy and safety of vedolizumab in the treatment of ulcerative colitis. Gastroenterol Hepatol. 2016 Dec;39(10):677-686. doi: 10.1016/j.gastrohep.2015.11.010. Epub 2016 Mar 2. English, Spanish.
Results Reference
background
PubMed Identifier
29042094
Citation
Gisbert JP, Chaparro M. Ustekinumab to treat Crohn's disease. Gastroenterol Hepatol. 2017 Dec;40(10):688-698. doi: 10.1016/j.gastrohep.2017.08.006. Epub 2017 Oct 16. English, Spanish.
Results Reference
background
PubMed Identifier
21407183
Citation
Ford AC, Sandborn WJ, Khan KJ, Hanauer SB, Talley NJ, Moayyedi P. Efficacy of biological therapies in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol. 2011 Apr;106(4):644-59, quiz 660. doi: 10.1038/ajg.2011.73. Epub 2011 Mar 15.
Results Reference
background
PubMed Identifier
24749763
Citation
Stidham RW, Lee TC, Higgins PD, Deshpande AR, Sussman DA, Singal AG, Elmunzer BJ, Saini SD, Vijan S, Waljee AK. Systematic review with network meta-analysis: the efficacy of anti-TNF agents for the treatment of Crohn's disease. Aliment Pharmacol Ther. 2014 Jun;39(12):1349-62. doi: 10.1111/apt.12749. Epub 2014 Apr 20.
Results Reference
background
PubMed Identifier
25933126
Citation
Gordon JP, McEwan PC, Maguire A, Sugrue DM, Puelles J. Characterizing unmet medical need and the potential role of new biologic treatment options in patients with ulcerative colitis and Crohn's disease: a systematic review and clinician surveys. Eur J Gastroenterol Hepatol. 2015 Jul;27(7):804-12. doi: 10.1097/MEG.0000000000000378.
Results Reference
background
PubMed Identifier
26515897
Citation
Ding NS, Hart A, De Cruz P. Systematic review: predicting and optimising response to anti-TNF therapy in Crohn's disease - algorithm for practical management. Aliment Pharmacol Ther. 2016 Jan;43(1):30-51. doi: 10.1111/apt.13445. Epub 2015 Oct 30.
Results Reference
background
PubMed Identifier
28992449
Citation
Park SH, Aniwan S, Loftus EV Jr. Advances in the use of biologics and other novel drugs for managing inflammatory bowel disease. Curr Opin Pharmacol. 2017 Dec;37:65-71. doi: 10.1016/j.coph.2017.09.007. Epub 2017 Oct 6.
Results Reference
background
PubMed Identifier
28906475
Citation
Lopetuso LR, Gerardi V, Papa V, Scaldaferri F, Rapaccini GL, Gasbarrini A, Papa A. Can We Predict the Efficacy of Anti-TNF-alpha Agents? Int J Mol Sci. 2017 Sep 14;18(9):1973. doi: 10.3390/ijms18091973.
Results Reference
background
PubMed Identifier
21180547
Citation
Siegel CA, Melmed GY. Predicting response to Anti-TNF Agents for the treatment of crohn's disease. Therap Adv Gastroenterol. 2009 Jul;2(4):245-51. doi: 10.1177/1756283X09336364.
Results Reference
background
PubMed Identifier
27366220
Citation
Kopylov U, Seidman E. Predicting durable response or resistance to antitumor necrosis factor therapy in inflammatory bowel disease. Therap Adv Gastroenterol. 2016 Jul;9(4):513-26. doi: 10.1177/1756283X16638833. Epub 2016 Apr 1.
Results Reference
background
PubMed Identifier
28961959
Citation
Hindryckx P, Vande Casteele N, Novak G, Khanna R, D'Haens G, Sandborn WJ, Danese S, Jairath V, Feagan BG. The Expanding Therapeutic Armamentarium for Inflammatory Bowel Disease: How to Choose the Right Drug[s] for Our Patients? J Crohns Colitis. 2018 Jan 5;12(1):105-119. doi: 10.1093/ecco-jcc/jjx117.
Results Reference
background
PubMed Identifier
26522261
Citation
Tew GW, Hackney JA, Gibbons D, Lamb CA, Luca D, Egen JG, Diehl L, Eastham Anderson J, Vermeire S, Mansfield JC, Feagan BG, Panes J, Baumgart DC, Schreiber S, Dotan I, Sandborn WJ, Kirby JA, Irving PM, De Hertogh G, Van Assche GA, Rutgeerts P, O'Byrne S, Hayday A, Keir ME. Association Between Response to Etrolizumab and Expression of Integrin alphaE and Granzyme A in Colon Biopsies of Patients With Ulcerative Colitis. Gastroenterology. 2016 Feb;150(2):477-87.e9. doi: 10.1053/j.gastro.2015.10.041. Epub 2015 Oct 30.
Results Reference
background
PubMed Identifier
25877762
Citation
Dahlen R, Magnusson MK, Bajor A, Lasson A, Ung KA, Strid H, Ohman L. Global mucosal and serum cytokine profile in patients with ulcerative colitis undergoing anti-TNF therapy. Scand J Gastroenterol. 2015;50(9):1118-26. doi: 10.3109/00365521.2015.1031167. Epub 2015 Apr 16.
Results Reference
background
PubMed Identifier
24969293
Citation
Eftekhari P, Glaubitz L, Breidert M, Neurath MF, Atreya R. Physiological intermolecular modification spectroscopy for the prediction of response to anti-tumor necrosis factor therapy in patients with inflammatory bowel diseases. Dig Dis. 2014;32(4):446-54. doi: 10.1159/000358151. Epub 2014 Jun 23.
Results Reference
background
PubMed Identifier
18489908
Citation
Meuwis MA, Fillet M, Lutteri L, Maree R, Geurts P, de Seny D, Malaise M, Chapelle JP, Wehenkel L, Belaiche J, Merville MP, Louis E. Proteomics for prediction and characterization of response to infliximab in Crohn's disease: a pilot study. Clin Biochem. 2008 Aug;41(12):960-7. doi: 10.1016/j.clinbiochem.2008.04.021. Epub 2008 May 6.
Results Reference
background
PubMed Identifier
28721978
Citation
Hassan EA, Ramadan HK, Ismael AA, Mohamed KF, El-Attar MM, Alhelali I. Noninvasive biomarkers as surrogate predictors of clinical and endoscopic remission after infliximab induction in patients with refractory ulcerative colitis. Saudi J Gastroenterol. 2017 Jul-Aug;23(4):238-245. doi: 10.4103/sjg.SJG_599_16.
Results Reference
background
PubMed Identifier
28644181
Citation
Feng T, Chen B, Li L, Huang S, Ben-Horin S, Qiu Y, Feng R, Li M, Mao R, He Y, Zeng Z, Zhang S, Chen M. Serum Interleukin 9 Levels Predict Disease Severity and the Clinical Efficacy of Infliximab in Patients with Crohn's Disease. Inflamm Bowel Dis. 2017 Oct;23(10):1817-1824. doi: 10.1097/MIB.0000000000001172.
Results Reference
background
PubMed Identifier
28717358
Citation
Fuchs F, Schillinger D, Atreya R, Hirschmann S, Fischer S, Neufert C, Atreya I, Neurath MF, Zundler S. Clinical Response to Vedolizumab in Ulcerative Colitis Patients Is Associated with Changes in Integrin Expression Profiles. Front Immunol. 2017 Jul 3;8:764. doi: 10.3389/fimmu.2017.00764. eCollection 2017.
Results Reference
background
PubMed Identifier
28981629
Citation
Planell N, Masamunt MC, Leal RF, Rodriguez L, Esteller M, Lozano JJ, Ramirez A, Ayrizono MLS, Coy CSR, Alfaro I, Ordas I, Visvanathan S, Ricart E, Guardiola J, Panes J, Salas A. Usefulness of Transcriptional Blood Biomarkers as a Non-invasive Surrogate Marker of Mucosal Healing and Endoscopic Response in Ulcerative Colitis. J Crohns Colitis. 2017 Oct 27;11(11):1335-1346. doi: 10.1093/ecco-jcc/jjx091.
Results Reference
background
PubMed Identifier
11987129
Citation
Barcelo-Batllori S, Andre M, Servis C, Levy N, Takikawa O, Michetti P, Reymond M, Felley-Bosco E. Proteomic analysis of cytokine induced proteins in human intestinal epithelial cells: implications for inflammatory bowel diseases. Proteomics. 2002 May;2(5):551-60. doi: 10.1002/1615-9861(200205)2:53.0.CO;2-O.
Results Reference
background
PubMed Identifier
23320753
Citation
Han NY, Choi W, Park JM, Kim EH, Lee H, Hahm KB. Label-free quantification for discovering novel biomarkers in the diagnosis and assessment of disease activity in inflammatory bowel disease. J Dig Dis. 2013 Apr;14(4):166-74. doi: 10.1111/1751-2980.12035.
Results Reference
background
PubMed Identifier
14988394
Citation
Hardwidge PR, Rodriguez-Escudero I, Goode D, Donohoe S, Eng J, Goodlett DR, Aebersold R, Finlay BB. Proteomic analysis of the intestinal epithelial cell response to enteropathogenic Escherichia coli. J Biol Chem. 2004 May 7;279(19):20127-36. doi: 10.1074/jbc.M401228200. Epub 2004 Feb 26.
Results Reference
background
PubMed Identifier
16947118
Citation
Hsieh SY, Shih TC, Yeh CY, Lin CJ, Chou YY, Lee YS. Comparative proteomic studies on the pathogenesis of human ulcerative colitis. Proteomics. 2006 Oct;6(19):5322-31. doi: 10.1002/pmic.200500541.
Results Reference
background
PubMed Identifier
20806340
Citation
M'Koma AE, Seeley EH, Washington MK, Schwartz DA, Muldoon RL, Herline AJ, Wise PE, Caprioli RM. Proteomic profiling of mucosal and submucosal colonic tissues yields protein signatures that differentiate the inflammatory colitides. Inflamm Bowel Dis. 2011 Apr;17(4):875-83. doi: 10.1002/ibd.21442. Epub 2010 Aug 30.
Results Reference
background
PubMed Identifier
19168159
Citation
Nanni P, Mezzanotte L, Roda G, Caponi A, Levander F, James P, Roda A. Differential proteomic analysis of HT29 Cl.16E and intestinal epithelial cells by LC ESI/QTOF mass spectrometry. J Proteomics. 2009 Jul 21;72(5):865-73. doi: 10.1016/j.jprot.2008.12.010. Epub 2009 Jan 8.
Results Reference
background
PubMed Identifier
21698720
Citation
Presley LL, Ye J, Li X, Leblanc J, Zhang Z, Ruegger PM, Allard J, McGovern D, Ippoliti A, Roth B, Cui X, Jeske DR, Elashoff D, Goodglick L, Braun J, Borneman J. Host-microbe relationships in inflammatory bowel disease detected by bacterial and metaproteomic analysis of the mucosal-luminal interface. Inflamm Bowel Dis. 2012 Mar;18(3):409-17. doi: 10.1002/ibd.21793. Epub 2011 Jun 22.
Results Reference
background
PubMed Identifier
23382084
Citation
Seeley EH, Washington MK, Caprioli RM, M'Koma AE. Proteomic patterns of colonic mucosal tissues delineate Crohn's colitis and ulcerative colitis. Proteomics Clin Appl. 2013 Aug;7(7-8):541-9. doi: 10.1002/prca.201200107. Epub 2013 May 8.
Results Reference
background
PubMed Identifier
17330946
Citation
Shkoda A, Werner T, Daniel H, Gunckel M, Rogler G, Haller D. Differential protein expression profile in the intestinal epithelium from patients with inflammatory bowel disease. J Proteome Res. 2007 Mar;6(3):1114-25. doi: 10.1021/pr060433m.
Results Reference
background
PubMed Identifier
18022963
Citation
Nanni P, Parisi D, Roda G, Casale M, Belluzzi A, Roda E, Mayer L, Roda A. Serum protein profiling in patients with inflammatory bowel diseases using selective solid-phase bulk extraction, matrix-assisted laser desorption/ionization time-of-flight mass spectrometry and chemometric data analysis. Rapid Commun Mass Spectrom. 2007;21(24):4142-8. doi: 10.1002/rcm.3323.
Results Reference
background
PubMed Identifier
28555885
Citation
Arbelaiz A, Azkargorta M, Krawczyk M, Santos-Laso A, Lapitz A, Perugorria MJ, Erice O, Gonzalez E, Jimenez-Aguero R, Lacasta A, Ibarra C, Sanchez-Campos A, Jimeno JP, Lammert F, Milkiewicz P, Marzioni M, Macias RIR, Marin JJG, Patel T, Gores GJ, Martinez I, Elortza F, Falcon-Perez JM, Bujanda L, Banales JM. Serum extracellular vesicles contain protein biomarkers for primary sclerosing cholangitis and cholangiocarcinoma. Hepatology. 2017 Oct;66(4):1125-1143. doi: 10.1002/hep.29291. Epub 2017 Aug 26.
Results Reference
background
PubMed Identifier
27153492
Citation
Spitzer MH, Nolan GP. Mass Cytometry: Single Cells, Many Features. Cell. 2016 May 5;165(4):780-91. doi: 10.1016/j.cell.2016.04.019.
Results Reference
background
PubMed Identifier
22476049
Citation
Bendall SC, Nolan GP, Roederer M, Chattopadhyay PK. A deep profiler's guide to cytometry. Trends Immunol. 2012 Jul;33(7):323-32. doi: 10.1016/j.it.2012.02.010. Epub 2012 Apr 2.
Results Reference
background
PubMed Identifier
28674539
Citation
Stikvoort A, Chen Y, Radestad E, Torlen J, Lakshmikanth T, Bjorklund A, Mikes J, Achour A, Gertow J, Sundberg B, Remberger M, Sundin M, Mattsson J, Brodin P, Uhlin M. Combining Flow and Mass Cytometry in the Search for Biomarkers in Chronic Graft-versus-Host Disease. Front Immunol. 2017 Jun 19;8:717. doi: 10.3389/fimmu.2017.00717. eCollection 2017.
Results Reference
background
PubMed Identifier
25981462
Citation
Nair N, Mei HE, Chen SY, Hale M, Nolan GP, Maecker HT, Genovese M, Fathman CG, Whiting CC. Mass cytometry as a platform for the discovery of cellular biomarkers to guide effective rheumatic disease therapy. Arthritis Res Ther. 2015 May 18;17(1):127. doi: 10.1186/s13075-015-0644-z.
Results Reference
background
PubMed Identifier
25253674
Citation
Gaudilliere B, Fragiadakis GK, Bruggner RV, Nicolau M, Finck R, Tingle M, Silva J, Ganio EA, Yeh CG, Maloney WJ, Huddleston JI, Goodman SB, Davis MM, Bendall SC, Fantl WJ, Angst MS, Nolan GP. Clinical recovery from surgery correlates with single-cell immune signatures. Sci Transl Med. 2014 Sep 24;6(255):255ra131. doi: 10.1126/scitranslmed.3009701.
Results Reference
background
PubMed Identifier
25437561
Citation
Fergusson JR, Smith KE, Fleming VM, Rajoriya N, Newell EW, Simmons R, Marchi E, Bjorkander S, Kang YH, Swadling L, Kurioka A, Sahgal N, Lockstone H, Baban D, Freeman GJ, Sverremark-Ekstrom E, Davis MM, Davenport MP, Venturi V, Ussher JE, Willberg CB, Klenerman P. CD161 defines a transcriptional and functional phenotype across distinct human T cell lineages. Cell Rep. 2014 Nov 6;9(3):1075-88. doi: 10.1016/j.celrep.2014.09.045. Epub 2014 Oct 23.
Results Reference
background
PubMed Identifier
27178470
Citation
van Unen V, Li N, Molendijk I, Temurhan M, Hollt T, van der Meulen-de Jong AE, Verspaget HW, Mearin ML, Mulder CJ, van Bergen J, Lelieveldt BP, Koning F. Mass Cytometry of the Human Mucosal Immune System Identifies Tissue- and Disease-Associated Immune Subsets. Immunity. 2016 May 17;44(5):1227-39. doi: 10.1016/j.immuni.2016.04.014. Epub 2016 May 10.
Results Reference
background
PubMed Identifier
24345887
Citation
Gerich ME, McGovern DP. Towards personalized care in IBD. Nat Rev Gastroenterol Hepatol. 2014 May;11(5):287-99. doi: 10.1038/nrgastro.2013.242. Epub 2013 Dec 17.
Results Reference
background
PubMed Identifier
26303131
Citation
Peyrin-Biroulet L, Sandborn W, Sands BE, Reinisch W, Bemelman W, Bryant RV, D'Haens G, Dotan I, Dubinsky M, Feagan B, Fiorino G, Gearry R, Krishnareddy S, Lakatos PL, Loftus EV Jr, Marteau P, Munkholm P, Murdoch TB, Ordas I, Panaccione R, Riddell RH, Ruel J, Rubin DT, Samaan M, Siegel CA, Silverberg MS, Stoker J, Schreiber S, Travis S, Van Assche G, Danese S, Panes J, Bouguen G, O'Donnell S, Pariente B, Winer S, Hanauer S, Colombel JF. Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE): Determining Therapeutic Goals for Treat-to-Target. Am J Gastroenterol. 2015 Sep;110(9):1324-38. doi: 10.1038/ajg.2015.233. Epub 2015 Aug 25.
Results Reference
background
PubMed Identifier
22405177
Citation
Rieder F, Karrasch T, Ben-Horin S, Schirbel A, Ehehalt R, Wehkamp J, de Haar C, Velin D, Latella G, Scaldaferri F, Rogler G, Higgins P, Sans M. Results of the 2nd scientific workshop of the ECCO (III): basic mechanisms of intestinal healing. J Crohns Colitis. 2012 Apr;6(3):373-85. doi: 10.1016/j.crohns.2011.11.009. Epub 2011 Dec 11. Erratum In: J Crohns Colitis. 2022 Aug 16;:
Results Reference
background
PubMed Identifier
22842618
Citation
Neurath MF, Travis SP. Mucosal healing in inflammatory bowel diseases: a systematic review. Gut. 2012 Nov;61(11):1619-35. doi: 10.1136/gutjnl-2012-302830. Epub 2012 Jul 27.
Results Reference
background
PubMed Identifier
25029615
Citation
Khanna R, Bouguen G, Feagan BG, D'Haens G, Sandborn WJ, Dubcenco E, Baker KA, Levesque BG. A systematic review of measurement of endoscopic disease activity and mucosal healing in Crohn's disease: recommendations for clinical trial design. Inflamm Bowel Dis. 2014 Oct;20(10):1850-61. doi: 10.1097/MIB.0000000000000131.
Results Reference
background
PubMed Identifier
21723220
Citation
Colombel JF, Rutgeerts P, Reinisch W, Esser D, Wang Y, Lang Y, Marano CW, Strauss R, Oddens BJ, Feagan BG, Hanauer SB, Lichtenstein GR, Present D, Sands BE, Sandborn WJ. Early mucosal healing with infliximab is associated with improved long-term clinical outcomes in ulcerative colitis. Gastroenterology. 2011 Oct;141(4):1194-201. doi: 10.1053/j.gastro.2011.06.054. Epub 2011 Jun 30.
Results Reference
background
PubMed Identifier
21939925
Citation
Peyrin-Biroulet L, Ferrante M, Magro F, Campbell S, Franchimont D, Fidder H, Strid H, Ardizzone S, Veereman-Wauters G, Chevaux JB, Allez M, Danese S, Sturm A; Scientific Committee of the European Crohn's and Colitis Organization. Results from the 2nd Scientific Workshop of the ECCO. I: Impact of mucosal healing on the course of inflammatory bowel disease. J Crohns Colitis. 2011 Oct;5(5):477-83. doi: 10.1016/j.crohns.2011.06.009. Epub 2011 Aug 3.
Results Reference
background
PubMed Identifier
26607562
Citation
Shah SC, Colombel JF, Sands BE, Narula N. Systematic review with meta-analysis: mucosal healing is associated with improved long-term outcomes in Crohn's disease. Aliment Pharmacol Ther. 2016 Feb;43(3):317-33. doi: 10.1111/apt.13475. Epub 2015 Nov 25.
Results Reference
background
PubMed Identifier
27043489
Citation
Pineton de Chambrun G, Blanc P, Peyrin-Biroulet L. Current evidence supporting mucosal healing and deep remission as important treatment goals for inflammatory bowel disease. Expert Rev Gastroenterol Hepatol. 2016 Aug;10(8):915-27. doi: 10.1586/17474124.2016.1174064. Epub 2016 Apr 18.
Results Reference
background
PubMed Identifier
28886962
Citation
Scoville EA, Schwartz DA. Endoscopy in inflammatory bowel disease: advances in disease management. Gastrointest Endosc. 2017 Dec;86(6):952-961. doi: 10.1016/j.gie.2017.08.034. Epub 2017 Sep 6. No abstract available.
Results Reference
background
PubMed Identifier
19700435
Citation
Arijs I, Li K, Toedter G, Quintens R, Van Lommel L, Van Steen K, Leemans P, De Hertogh G, Lemaire K, Ferrante M, Schnitzler F, Thorrez L, Ma K, Song XY, Marano C, Van Assche G, Vermeire S, Geboes K, Schuit F, Baribaud F, Rutgeerts P. Mucosal gene signatures to predict response to infliximab in patients with ulcerative colitis. Gut. 2009 Dec;58(12):1612-9. doi: 10.1136/gut.2009.178665. Epub 2009 Aug 20.
Results Reference
background
PubMed Identifier
20848504
Citation
Arijs I, Quintens R, Van Lommel L, Van Steen K, De Hertogh G, Lemaire K, Schraenen A, Perrier C, Van Assche G, Vermeire S, Geboes K, Schuit F, Rutgeerts P. Predictive value of epithelial gene expression profiles for response to infliximab in Crohn's disease. Inflamm Bowel Dis. 2010 Dec;16(12):2090-8. doi: 10.1002/ibd.21301.
Results Reference
background
PubMed Identifier
20196149
Citation
Li Z, Arijs I, De Hertogh G, Vermeire S, Noman M, Bullens D, Coorevits L, Sagaert X, Schuit F, Rutgeerts P, Ceuppens JL, Van Assche G. Reciprocal changes of Foxp3 expression in blood and intestinal mucosa in IBD patients responding to infliximab. Inflamm Bowel Dis. 2010 Aug;16(8):1299-310. doi: 10.1002/ibd.21229.
Results Reference
background
PubMed Identifier
19286392
Citation
Olsen T, Goll R, Cui G, Christiansen I, Florholmen J. TNF-alpha gene expression in colorectal mucosa as a predictor of remission after induction therapy with infliximab in ulcerative colitis. Cytokine. 2009 May;46(2):222-7. doi: 10.1016/j.cyto.2009.02.001. Epub 2009 Mar 14.
Results Reference
background
PubMed Identifier
22486187
Citation
Rismo R, Olsen T, Cui G, Christiansen I, Florholmen J, Goll R. Mucosal cytokine gene expression profiles as biomarkers of response to infliximab in ulcerative colitis. Scand J Gastroenterol. 2012 May;47(5):538-47. doi: 10.3109/00365521.2012.667146.
Results Reference
background
PubMed Identifier
27866814
Citation
Viazis N, Giakoumis M, Bamias G, Goukos D, Koukouratos T, Katopodi K, Karatzas P, Triantos C, Tsolias C, Theocharis G, Daikos GL, Ladas SD, Karamanolis DG, Mantzaris GJ. Predictors of tissue healing in ulcerative colitis patients treated with anti-TNF. Dig Liver Dis. 2017 Jan;49(1):29-33. doi: 10.1016/j.dld.2016.10.008. Epub 2016 Oct 20.
Results Reference
background
PubMed Identifier
17258735
Citation
D'Haens G, Sandborn WJ, Feagan BG, Geboes K, Hanauer SB, Irvine EJ, Lemann M, Marteau P, Rutgeerts P, Scholmerich J, Sutherland LR. A review of activity indices and efficacy end points for clinical trials of medical therapy in adults with ulcerative colitis. Gastroenterology. 2007 Feb;132(2):763-86. doi: 10.1053/j.gastro.2006.12.038. Epub 2006 Dec 20. No abstract available.
Results Reference
background
PubMed Identifier
15472670
Citation
Daperno M, D'Haens G, Van Assche G, Baert F, Bulois P, Maunoury V, Sostegni R, Rocca R, Pera A, Gevers A, Mary JY, Colombel JF, Rutgeerts P. Development and validation of a new, simplified endoscopic activity score for Crohn's disease: the SES-CD. Gastrointest Endosc. 2004 Oct;60(4):505-12. doi: 10.1016/s0016-5107(04)01878-4.
Results Reference
background
PubMed Identifier
26353983
Citation
Vuitton L, Marteau P, Sandborn WJ, Levesque BG, Feagan B, Vermeire S, Danese S, D'Haens G, Lowenberg M, Khanna R, Fiorino G, Travis S, Mary JY, Peyrin-Biroulet L. IOIBD technical review on endoscopic indices for Crohn's disease clinical trials. Gut. 2016 Sep;65(9):1447-55. doi: 10.1136/gutjnl-2015-309903. Epub 2015 Sep 9.
Results Reference
background
PubMed Identifier
17241860
Citation
Kamm MA, Sandborn WJ, Gassull M, Schreiber S, Jackowski L, Butler T, Lyne A, Stephenson D, Palmen M, Joseph RE. Once-daily, high-concentration MMX mesalamine in active ulcerative colitis. Gastroenterology. 2007 Jan;132(1):66-75; quiz 432-3. doi: 10.1053/j.gastro.2006.10.011. Epub 2006 Oct 12.
Results Reference
background
PubMed Identifier
21045814
Citation
D'Haens GR, Panaccione R, Higgins PD, Vermeire S, Gassull M, Chowers Y, Hanauer SB, Herfarth H, Hommes DW, Kamm M, Lofberg R, Quary A, Sands B, Sood A, Watermeyer G, Lashner B, Lemann M, Plevy S, Reinisch W, Schreiber S, Siegel C, Targan S, Watanabe M, Feagan B, Sandborn WJ, Colombel JF, Travis S. The London Position Statement of the World Congress of Gastroenterology on Biological Therapy for IBD with the European Crohn's and Colitis Organization: when to start, when to stop, which drug to choose, and how to predict response? Am J Gastroenterol. 2011 Feb;106(2):199-212; quiz 213. doi: 10.1038/ajg.2010.392. Epub 2010 Nov 2. Erratum In: Am J Gastroenterol. 2011 Feb;106(2):375. Watermayer, G [corrected to Watermeyer, G].
Results Reference
background
PubMed Identifier
16603634
Citation
Van Assche G, Sandborn WJ, Feagan BG, Salzberg BA, Silvers D, Monroe PS, Pandak WM, Anderson FH, Valentine JF, Wild GE, Geenen DJ, Sprague R, Targan SR, Rutgeerts P, Vexler V, Young D, Shames RS. Daclizumab, a humanised monoclonal antibody to the interleukin 2 receptor (CD25), for the treatment of moderately to severely active ulcerative colitis: a randomised, double blind, placebo controlled, dose ranging trial. Gut. 2006 Nov;55(11):1568-74. doi: 10.1136/gut.2005.089854. Epub 2006 Apr 7.
Results Reference
background
PubMed Identifier
23000597
Citation
D'Haens G, Feagan B, Colombel JF, Sandborn WJ, Reinisch W, Rutgeerts P, Carbonnel F, Mary JY, Danese S, Fedorak RN, Hanauer S, Lemann M; International Organization for Inflammatory Bowel Diseases (IOIBD) and the Clinical Trial Committee Clincom of the European Crohn's and Colitis Organisation (ECCO). Challenges to the design, execution, and analysis of randomized controlled trials for inflammatory bowel disease. Gastroenterology. 2012 Dec;143(6):1461-9. doi: 10.1053/j.gastro.2012.09.031. Epub 2012 Sep 20.
Results Reference
background
PubMed Identifier
21122572
Citation
Nunes T, Barreiro-de Acosta M, Nos P, Marin-Jimenez I, Bermejo F, Ceballos D, Iglesias E, Gomez-Senent S, Torres Y, Ponferrada A, Arevalo JA, Hernandez V, Calvet X, Ginard D, Monfort D, Chaparro M, Mancenido N, Dominguez-Antonaya M, Villalon C, Perez-Calle JL, Munoz C, Nunez H, Carpio D, Aramendiz R, Bujanda L, Estrada-Oncins S, Hermida C, Barrio J, Casis MB, Duenas-Sadornil MC, Fernandez L, Calvo-Cenizo MM, Botella B, de Francisco R, Ayala E, Sans M; RECLICU Study Group of GETECCU. Usefulness of oral beclometasone dipropionate in the treatment of active ulcerative colitis in clinical practice: the RECLICU Study. J Crohns Colitis. 2010 Dec;4(6):629-36. doi: 10.1016/j.crohns.2010.07.003.
Results Reference
background

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Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease

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