World Congress at ACG2017

Simultaneous Plenary Session 4C: IBD

74 - A Novel Serum Test to Describe the Mucosal Healing State by Disease Location in Crohn’s Disease Patients

Wednesday, October 18
8:40 AM - 8:50 AM
Location: W414 (Level 4)



Category: IBD       

Séverine Vermeire, MD, PhD1, Geert D'Haens, MD, PhD2, Michael Hale, PhD3, Venkateswarlu Kondragunta, PhD3, Kurt Bray, PhD3, Anjali Jain, PhD3, David Laharie, MD, PhD4
1University Hospitals Leuven, Leuven, Vlaams-Brabant, Belgium; 2Academic Medical Center, Amsterdam, Noord-Holland, Netherlands; 3Prometheus Laboratories, Inc., San Diego, CA; 4CHU de Bordeaux, Pessac, France
Introduction: Non-invasive serological tests can be an attractive option as adjuncts or surrogates for endoscopy in the management of IBD patients. Their utility is particularly helpful in patients with Crohn’s disease (CD) given its transmural nature and lack of optimal endoscopic accessibility to the small bowel. A newly developed serological test has been shown to be an effective tool for assessing the intestinal mucosal state in CD patients. The aim of the present study was to assess the diagnostic performance and clinical utility of this novel test in specific subtypes of CD patients classified by the location of their disease.

Methods: A 13-biomarker (Ang1, Ang2, CEACAM1, CRP, EMMPRIN, IL7, mmp-1, -2, -3, -9, SAA1, TGF, and VCAM1) mucosal healing monitoring test termed as the Mucosal Healing Index (MHI) has been developed and validated on a combined cohort of 748 serum specimens with matching colonoscopy scores. MHI is a scale of 0-100 where 0-40 identifies patients in remission (CDEIS < 3) or mild (CDEIS 3-8) endoscopic disease and 50-100 identifies patients with endoscopically active (CDEIS ≥3) disease. Multiple logistic regression models were used in developing the MHI score. In the present study, validation of the MHI, according to disease location, has been evaluated in 412 longitudinal specimens from 118 CD patients collected during the TAILORIX clinical trial. Specimens were collected from patients at the time of or close to endoscopy. Endoscopic scoring was centrally read and MH was defined as the absence of visual endoscopic ulcers. MHI test assay performance was assessed for sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) in the combined group and by each disease location.

Results: Patient characteristics are shown in Table 1. Disease locations were classified according to the Montreal classification. Test accuracy was 95%, 90%, and 87% for ileal, ileocolonic, and colonic disease, respectively. The detailed performance across disease locations is shown in Table 2.

Discussion: A novel serum test for the non-invasive evaluation of mucosal health shows comparable performance across ileal, ileocolonic and colonic anatomic disease locations in patients with CD. These results further validate the clinical utility of the test as a beneficial aid in assessing the state of the intestinal mucosa in CD patients regardless of disease location.

Supported by Industry Grant: No

Disclosures: Does Disclose

Séverine Vermeire indicated no relevant financial relationships.
Geert D''Haens indicated no relevant financial relationships.
Michael Hale: Prometheus Laboratories Inc. – Employee.
Venkateswarlu Kondragunta: Prometheus Therapeutics and Diagnostics – Employee.
Kurt Bray: Prometheus Laboratories – Employee.
Anjali Jain: Prometheus Laboratories Inc. – Employee.
David Laharie: MSD – Advisory Committee/Board Member. Pfizer – Advisory Committee/Board Member. Theradiag – Consultant.

Table 1. Crohn’s Disease Patient Characteristics

































  Ileal (L1) Colonic (L2) Ileocolonic (L3)
Patients [n (%)] 27 (22.9) 20 (16.9) 71 (60.2)
Age [mean in years (SD)] 37 (16) 41 (15) 31 (12)
Male Gender [n (%)] 9 (33.3) 7 (35) 29 (40.8)
Active Disease at Baseline [n (%)], (CDEIS:≥3) 26 (96.3) 19 (95.0) 69 (97.2)

Table 2. MH Index Performance by Crohn’s Disease Location













































CD Location Test Accuracy Sensitivity Specificity PPV NPV

All Patients


(# samples: 412)

90%


(95% CI: ±87% to 93%)

82%


(95% CI: ±75% to 89%)

94%


(95% CI: ±91% to 97%)

87%


(95% CI: ±80% to 93%)

92%


(95% CI: ±88% to 95%)

Ileal only


(# samples: 96)

95%


(95% CI: ±88% to 99%)

86%


(95% CI: +65% to 97%)

98%


(95% CI: +91% to 100%)

95%


(95% CI: +73% to 99%)

95%


(95% CI: +87% to 98%)

Ileocolonic


(# samples: 244)

90%


(95% CI: ±85% to 94%)

80%


(95% CI: ±69% to 89%)

95%


(95% CI: +90% to 98%)

89%


(95% CI: +80% to 94%)

90%


(95% CI: +85% to 94%)

Colonic only


(# samples: 72)

87%


(95% CI: ±77% to 94%)

89%


(95% CI: ±67% to 99%)

86%


(95% CI: ±73% to 95%)

74%


(95% CI: ±57% to 86%)

95%


(95% CI: ±84% to 99%)

Citation: . A NOVEL SERUM TEST TO DESCRIBE THE MUCOSAL HEALING STATE BY DISEASE LOCATION IN CROHN’S DISEASE PATIENTS. Program No. 74. World Congress of Gastroenterology at ACG2017 Meeting Abstracts. Orlando, FL: American College of Gastroenterology.

Geert R. D'Haens

Professor of Gastroenterology
Academic Medical Center
Amsterdam, Noord-Holland, Netherlands

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