How Should a Patient With Known Crohn s Disease and a Flare of Symptoms Be Evaluated?

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1 How Should a Patient With Known Crohn s Disease and a Flare of Symptoms Be Evaluated? Edward V. Loftus, Jr., M.D. Professor of Medicine Division of Gastroenterology and Hepatology Mayo Clinic Rochester, Minnesota, USA

2 Overview The challenge of diagnosis and disease activity assessment C-reactive protien Serologies Fecal markers of inflammation Capsule endoscopy CT enterography MR enterography

3 Endoscopic Indices in Crohn s Crohn s Disease Endoscopic Index of Severity (CDEIS) Prospectively developed and validated Has been used in RCTs Based on # segments with deep or superficial ulcers, % segmental involvement, % segmental ulceration, presence of ulcerated or non-ulcerated stenosis Correlation with clinical activity and endoscopic activity is modest at best Prospective GETAID trial of endoscopic-directed prednisolone versus standard taper no significant difference in the 2 groups Mary et al, Gut 1989;30:983; Cellier et al, Gut 1994;35:231; Landi et al, Gastroenterology 1992;102:1647.

4 Endoscopic Indices in Crohn s Disease Simple Endoscopic Score for Crohn s Disease (SES-CD) Multicenter European study Ulcer size, ulcerated surface, affected surface, luminal narrowing 4 point scale for each Easier to calculate Low interobserver variability Correlates well with CDEIS, CRP, CDAI Daperno et al, Gastrointest Endosc 2004;60:590.

5 Endoscopic Indices in Crohn s Disease Rutgeerts score For post-op recurrence: ileocolonic anastomosis Score 0 to 4: scores of 3 to 4 predict clinical relapse (diffuse aphthous ulcers, large ulcers) Rutgeerts et al, Gastroenterology 1990;99:956

6 CRP: Correlation with Crohn s Disease Activity (n = 104) Moderate clinical activity Elevated sedimentation rate Thrombocytosis Anemia Hypoalbuminemia Endoscopic activity Radiographic activity Histologic activity Severe activity Odds Ratio (95% CI) 4.5 (1.1-18) 10.8 (2.5-46) 9.7 (2.1-46) 4.7 (2.0-11) 9.6 (2.0-46) 4.2 (1.6-11) 2.2 ( ) 2.2 ( ) 10.6 ( ) However, at 0.8 mg/dl cutoff, overall sensitivity was 55% and specificity was 77% using endoscopic activity as gold standard. Solem et al. Inflamm Bowel Dis 2005;11:

7 Frequency of Disease Behavior (%) Complications Increase With Antibody Sums P trend = Non-penetrating, non-stricturing Perianal penetrating only Internal penetrating/stricturing only 60 * * 1.9 * 2.3 * * Odds Ratio N = 40 N = 60 N = 42 N = 29 Number of Immune Responses 4 N = 12 Dubinsky M, et al. Amer J Gastroenterology. 101:2006.

8 Fecal Lactoferrin Iron-binding glycoprotein secreted by secondary granules of neutrophils, resistant to proteolysis 104 Crohn s, 80 UC, 31 IBS, 56 controls Fecal samples frozen, later tested with ELISA for lactoferrin IBD vs IBS: 86% sensitivity and 100% specificity (helpful even in inactive IBD) Active vs inactive IBD: 78% sensitivity and 90% specificity Kane SV et al, Am J Gastroenterol 2003;98:

9 Sensitivity/Specificity of 4 Neutrophil-Derived Stool Markers in UC (n = 76) Sensitivity (%) Specificity (%) PMN-elastase Lysozyme Calprotectin Lactoferrin PMN-e + Calprotectin PMN-e + Lactoferrin Calprotectin + Lactoferrin 1 Composite index (all three) Conclusion: PMN-elastase, Calprotectin and Lactoferrin represent useful markers of disease activity 1 +ve if both parameters +ve 2 +ve if 2/3 parameters +ve Langhorst et al, Inflamm Bowel Dis 2005;11:

10 Calprotectin: Predictive Marker of Relapse in UC But Not Crohn s 38 Crohn s patients and 41 UC patients were followed for 12 months 12-month relapse risk in Crohn s for lo-calprotectin was <20% vs. high-calprotectin 50% 12-month relapse risk in UC for low was <10% vs. high >80% In UC, sensitivity of calprotectin > 150 mcg/g in predicting relapse was 89%, specificity 82% In Crohn s, sensitivity was 97% but specificity was only 43% Fecal calprotectin is a stronger predictor of relapse in UC than Crohn s Costa et al, Gut 2005;54:364

11 Small Intestinal Crohn s Disease as Seen by Capsule Endoscopy Detects erosions in suspected Crohn s disease with negative SBFT / colonoscopy

12 Capsule Endoscopy Larger studies needed to establish the role of CE in patients with suspected Crohn s Need studies with uniform gold standard Need to examine specificity issue No significant difference between CE and other modalities in patients suspected Crohn s Larger studies needed to establish the role of CE in patients with CD

13 Capsule Retention Low incidence in suspected Crohn s As high as 13% in known Crohn s? Incidence may also be high in NSAID enteropathy which mimics Crohn s

14 CTE Technique CTE Routine CT Oral contrast Neutral Positive Oral contrast volume ml ml Slice thickness 1-3 mm 5 mm Reformats Coronal None

15 Correlation with Active Disease Enhancement Thickening Stratification Comb Sign Fatty Proliferation

16 Comb Sign

17 Ileoscopy Endoscopic Correlation

18 Correlations Mural enhancement and thickening 2 retrospective series CRP and increased mesenteric fat density Bodily KD et al. Radiology. 2006;238: Booya F et al. Radiology. 2006;241: Colembel JF et al. Gut. 2006;55:

19 Sensitivity ROC Curve Based on Clinical and Laboratory Parameters CDAI CRP Hematocrit Albumin AUC: Specificity Bruining DH et al. ACG 2008.

20 Association of CTE Parameters with Active Disease Univariate Analysis CTE Findings Odds Ratio for Active Disease (95% CI) P-value Mural Enhancement Comb Sign Stratification Fat Stranding Wall Thickening 8.4 (3.7, 19.2) 5.1 (2.4, 10.8) 5.8 (2.8, 12.1) 4.3 (1.8, 10.5) 7.1 (3.1, 16.3) < < < < Bruining DH et al. Am J Gastroenterol 2008 Suppl

21 Multivariate Analysis Mural Enhancement Comb Sign Odds Ratio for Active Disease (95% CI) 3.7 (1.4, 10.0) 3.4 (1.3, 9.1) P-value Bruining DH et al. Am J Gastroenterol 2008 Suppl

22 Sensitivity ROC Curve Based on Significant Findings in Multivariate Model AUC:0.75 Hyperenhancement Comb Sign Specificity Bruining DH et al. ACG 2008.

23 Clinical Benefit of CTE Clinical Review & Pre-CTE Clinical Assessment CTE Post-CTE Clinical Assessment CTE did not replicate original impression (poor correlation) No strictures at CTE in about half the pts with clinical suspicion CTE findings changed impression of steroid benefit in 61% Higgins PDR, et al. Inflamm Bowel Dis 2006; 13:262

24 Alterations to Clinical Management Plans Based on CT Enterography Findings: Prospective Study of 273 Patients CT enterography-related changes Exclude CD Exclude active smallbowel diseases Add new medication Remove medication Surgical referral Other Established CD (n=145) 70 (48.3%) NA 20 (13.8%) 21 (14.5%) 13 (9.0%) 5 (3.4%) 11 (7.6%) Suspected CD (n=128) 69 (53.9%) 49 (38.3%) NA 4 (3.1%) 6 (4.7%) 5 (3.9%) 5 (3.9%) Bruining DH et al. Presented at: DDW 2008; May 2008; San Diego, California. Presentation #S1211.

25 CTE-Related Change in Level of Confidence (LOC) For CD or Complications (n=273) Total (n=273) Established Crohn s Disease (n=145) Suspected Crohn s Disease (n=128) CTE-related LOC Δ 247 (90.5%) 135 (93.1%) 112 (87.5%) Any Significant LOC Δ 212 (77.6%) 124 (85.5%) 88 (68.8%) Active Disease Significant LOC Δ 138 (50.4%) 76 (52.4%) 62 (48.4%) Stricturing Disease Significant LOC Δ 127 (46.5%) 79 (54.5%) 48 (37.5%) Fistula Significant LOC Δ 109 (39.9%) 64 (44.1%) 45 (35.2%) Abscess Significant LOC Δ 92 (33.7%) 55 (37.9%) 37 (68.8%) Bruining DH et al. Presented at: DDW 2008; May 2008; San Diego, California. Presentation #S1211.

26 Radiation Exposure in a Population-Based IBD Cohort: Olmsted County, Minnesota, (n=215) Median total effective dose (msv) Upper quartile range (msv) Annualized median ED (msv/year) Crohn s Disease Ulcerative Colitis After adjusting for duration of disease, CD patients had 2.46 times greater total effective doses than UC patients (95% CI: 1.5, 4.1; P=0.001) CT scans accounted for 51% of ED in patients with Crohn s disease; 40% in patients with ulcerative colitis This study led to a change in practice 30% dose reduction for CTE Peloquin JM et al. Am J Gastroenterol 2008; 103:

27 Ileosigmoid fistula: CT vs MR enterography CTE MRE

28 MRE - Contrast Enhancement Patient with known Crohn s disease, on AZA, experienced flare of symptoms after years of remission Colonoscopy and ileoscopy normal SBFT normal

29 Conclusions CRP may be a marker of disease activity in selected patients with Crohn s Sensitivity and specificity are insufficient to be relied upon as sole marker May help predict short-term relapse in Crohn s Serologies may be helpful in prognosticating disease behavior in Crohn s disease Need more prospective studies Fecal markers especially calprotectin appear promising at both detecting disease activity and predicting relapse

30 Conclusions Capsule endoscopy (CE) is extremely sensitive and may detect small bowel lesions in those with suspected Crohn s but who show up negative on conventional tests Concerns about specificity and capsule retention limit its use CT enterography is a noninvasive method of diagnosing or assessing disease activity in suspected or known Crohn s Complementary to SBFT, but potentially more sensitive MRI enterography is rapidly improving - no radiation

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