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DOP051 Usefulness of a faecal calprotectin rapid semiquantitative test in predicting relapse in patients with ulcerative colitis in remission
DOP Session 6
Predicting outcome
analysis was a Mayo-1 endoscopic sub-score (OR = 6.27, 95% CI 2.75 14.30, p < 0.001). Conclusions: Patients with Mayo sub-score 1 presented a worse clinical course than those with Mayo sub-score 0, regardless of the extension of UC. This study demonstrated that mucosal healing should only be considered for patients with an endoscopic Mayo score of 0. DOP051 Usefulness of a faecal calprotectin rapid semiquantitative test in predicting relapse in patients with ulcerative colitis in remission E. Garcia-Planella1 , M. Manyosa2,3 , M. Chaparro4 , M. Barreirode-Acosta5 , B. Beltr´ an6 , E. Ricart7 , V. García-S´ anchez8 , M. Esteve9 , M. Piqueras10 , F. Bermejo11 , A. L´ opez-Sanrom´ an12 , C. Taxonera12 , J. Lla´ o13 , J.P. Gisbert4 , E. Cabr´ e3 , E. Dom` enech3 *. 1 Hospital de la Santa Creu i Sant Pau, Gastroenterology, Barcelona, Spain, 2 Hospital Universitari Germans Trias i Pujol and CIBERehd, Gastroenterology Unit, Badalona, Spain, 3 Hospital Universitari Germans Trias i Pujol, Gastroenterology, Badalona, Spain, 4 Hospital La Princesa, Gastroenterology, Madrid, Spain, 5 Hospital Universitario de Santiago, Gastroenterology, Santiago de Compostela, Spain, 6 IIS Hospital La Fe, Gastroenterology, Valencia, Spain, 7 Hospital Clínic, Gastroenterology, Barcelona, Spain, 8 Hospital Reina Sofía, Gastroenterology, C´ ordoba, Spain, 9 Hospital M´ utua Terrassa, Gastroenterology, Terrassa, Spain, 10 Consorci Sanitari Terrassa, Gastroenterology, Terrassa, Spain, 11 Hospital de Fuenlabrada, Gastroenterology, Fuenlabrada, Spain, 12 Hospital Ram´ on y Cajal, Gastroenterology, Madrid, Spain, 13 Xarxa Hospital` aria Althaia, Gastroenterology, Manresa, Spain Background: Faecal calprotectin (CALf) is fairly correlated with clinical and endoscopic activity in ulcerative colitis (UC), and it has also demonstrated to be a good predictor of relapse. However, the routinely use of CALf measurement is constrained by the need for the patient to carry stool samples, as well as handling and processing them in the laboratory. The availability of hand held, single-use devices for CALf measurement that could be performed by the patient himself, might spread the use of CALf in clinical practice. Aim: To evaluate the usefulness of a rapid semi-quantitative test of CALf in predicting relapse in patients with UC in remission. Methods: A prospective, multicentre study that included patients with left-sided or extensive UC in clinical remission for at least 6 months on maintenance treatment with mesalazine. At baseline and every 3 months, patients were evaluated clinically and semi-quantitative CALf was measured using a monoclonal immunochromatography rapid test (PreventID Caldetect, Immunodiagnostic AG, Germany) without manipulation of stools or laboratory analysis, until relapse or 12 months of follow-up. Results: At least one determination of CALf with clinical follow-up was available in 192 out 206 patients initially included in the study. 55% with extensive UC, 62% required corticosteroids in the past, and 88% were non-smokers. From a total of 695 measurements of CALf, 81 (12%) were above the upper threshold of normality of the test (>60 mg/g) and 57 (8%) had limiting values (15 60 mg/g). During follow-up, 32 relapses (17% of patients) occurred. Having a CALf >60 mg/g was significantly associated with relapse at follow-up (35% vs. 12%, p < 0.0001), with a PPV of 35% and a NPV of 88%. 644 CALf determinations with a three-month follow-up were available; undetectable CALf was significantly associated with absence of recurrence, with a PPV of 100% and a NPV of 93% (0% vs. 6%, p = 0.002). Conclusions: Rapid semi-quantitative measurement of CALf, with no need for laboratory analysis and faecal samples
S39 handling, may be useful for monitoring patients with UC in remission. DOP052 Active smoking, and pre-operative anti-flagellin Fla2 and pANCA antibodies may predict postoperative Crohn’s disease recurrence: results from a prospective mono-centric trial M. Noben1 *, A. de Buck van Overstraeten2 , S. Lockton3 , G. De Hertogh4 , F. Princen3 , A. Wolthuis2 , G. Van Assche1 , S. Vermeire1 , S. Singh3 , A. D’Hoore2 , M. Ferrante1 . 1 University Hospitals Leuven, Department of Gastroenterology, Leuven, Belgium, 2 University Hospitals Leuven, Department of Abdominal Surgery, Leuven, Belgium, 3 Prometheus Laboratories, Department of Research and Development, San Diego, United States, 4 University Hospitals Leuven, Department of Pathology, Leuven, Belgium Background: Preventing postoperative endoscopic (ER) and clinical recurrence (CR) remains a challenging issue in patients with Crohn’s disease (CD) undergoing an intestinal resection. Several clinical and histological risk factors have been identified, and may guide postoperative prophylactic CD therapy. We evaluated if pre-operative serological markers could strengthen prediction of postoperative ER and CR. Methods: The study population consisted of 100 consecutive patients (41 males, 27 active smokers, median age 41.7 years) undergoing an ileal resection with ileocolonic anastomosis for refractory CD, in whom a serum sample was collected 1 week prior to surgery. All patients underwent a postoperative endoscopic evaluation at 6 months. The primary endpoint, ER, was defined as a postoperative endoscopic recurrence score of i3 or i4. Secondary endpoints included time to clinical recurrence. Sera were analysed blindly at Prometheus laboratories for the expression of ASCA IgA and IgG antibodies, three different anti-flagellin antibodies (CBir1, Fla2 and FlaX), OmpC, and pANCA. The Q3 value of each individual marker in this dataset was defined as the cut-off point. Predictors of both ER and CR in univariate analyses were included in the binary logistic and Cox regression analysis. Results: Twenty-five patients developed ER at 6 months. Fla2 > 66 EU [Odds ratio 3.0 (95% confidence interval 1.1 8.7), p = 0.037], and active smoking [3.1 (1.1 8.8), p = 0.029], were independently associated with ER. During a median follow-up of 23.6 months, 29 patients developed a CR, with Fla2 > 66 EU [2.2 (1.0 4.6), p = 0.041], pANCA positivity [2.5 (1.2 5.4), p = 0.016], and active smoking [2.6 (1.2 5.5), p = 0.011], as independent risk factors. A cumulative risk score was developed by combining 3 risk factors (Fla2 > 66 EU, pANCA positivity, and active smoking). Based on this cumulative risk score, we could observe a significant and gradual increased risk of both ER (Figure 1, linear-by-linear p < 0.001) and CR (Figure 2, LogRank p < 0.001).
Figure 1. Endoscopic recurrence at month 6.
Predicting outcome
analysis was a Mayo-1 endoscopic sub-score (OR = 6.27, 95% CI 2.75 14.30, p < 0.001). Conclusions: Patients with Mayo sub-score 1 presented a worse clinical course than those with Mayo sub-score 0, regardless of the extension of UC. This study demonstrated that mucosal healing should only be considered for patients with an endoscopic Mayo score of 0. DOP051 Usefulness of a faecal calprotectin rapid semiquantitative test in predicting relapse in patients with ulcerative colitis in remission E. Garcia-Planella1 , M. Manyosa2,3 , M. Chaparro4 , M. Barreirode-Acosta5 , B. Beltr´ an6 , E. Ricart7 , V. García-S´ anchez8 , M. Esteve9 , M. Piqueras10 , F. Bermejo11 , A. L´ opez-Sanrom´ an12 , C. Taxonera12 , J. Lla´ o13 , J.P. Gisbert4 , E. Cabr´ e3 , E. Dom` enech3 *. 1 Hospital de la Santa Creu i Sant Pau, Gastroenterology, Barcelona, Spain, 2 Hospital Universitari Germans Trias i Pujol and CIBERehd, Gastroenterology Unit, Badalona, Spain, 3 Hospital Universitari Germans Trias i Pujol, Gastroenterology, Badalona, Spain, 4 Hospital La Princesa, Gastroenterology, Madrid, Spain, 5 Hospital Universitario de Santiago, Gastroenterology, Santiago de Compostela, Spain, 6 IIS Hospital La Fe, Gastroenterology, Valencia, Spain, 7 Hospital Clínic, Gastroenterology, Barcelona, Spain, 8 Hospital Reina Sofía, Gastroenterology, C´ ordoba, Spain, 9 Hospital M´ utua Terrassa, Gastroenterology, Terrassa, Spain, 10 Consorci Sanitari Terrassa, Gastroenterology, Terrassa, Spain, 11 Hospital de Fuenlabrada, Gastroenterology, Fuenlabrada, Spain, 12 Hospital Ram´ on y Cajal, Gastroenterology, Madrid, Spain, 13 Xarxa Hospital` aria Althaia, Gastroenterology, Manresa, Spain Background: Faecal calprotectin (CALf) is fairly correlated with clinical and endoscopic activity in ulcerative colitis (UC), and it has also demonstrated to be a good predictor of relapse. However, the routinely use of CALf measurement is constrained by the need for the patient to carry stool samples, as well as handling and processing them in the laboratory. The availability of hand held, single-use devices for CALf measurement that could be performed by the patient himself, might spread the use of CALf in clinical practice. Aim: To evaluate the usefulness of a rapid semi-quantitative test of CALf in predicting relapse in patients with UC in remission. Methods: A prospective, multicentre study that included patients with left-sided or extensive UC in clinical remission for at least 6 months on maintenance treatment with mesalazine. At baseline and every 3 months, patients were evaluated clinically and semi-quantitative CALf was measured using a monoclonal immunochromatography rapid test (PreventID Caldetect, Immunodiagnostic AG, Germany) without manipulation of stools or laboratory analysis, until relapse or 12 months of follow-up. Results: At least one determination of CALf with clinical follow-up was available in 192 out 206 patients initially included in the study. 55% with extensive UC, 62% required corticosteroids in the past, and 88% were non-smokers. From a total of 695 measurements of CALf, 81 (12%) were above the upper threshold of normality of the test (>60 mg/g) and 57 (8%) had limiting values (15 60 mg/g). During follow-up, 32 relapses (17% of patients) occurred. Having a CALf >60 mg/g was significantly associated with relapse at follow-up (35% vs. 12%, p < 0.0001), with a PPV of 35% and a NPV of 88%. 644 CALf determinations with a three-month follow-up were available; undetectable CALf was significantly associated with absence of recurrence, with a PPV of 100% and a NPV of 93% (0% vs. 6%, p = 0.002). Conclusions: Rapid semi-quantitative measurement of CALf, with no need for laboratory analysis and faecal samples
S39 handling, may be useful for monitoring patients with UC in remission. DOP052 Active smoking, and pre-operative anti-flagellin Fla2 and pANCA antibodies may predict postoperative Crohn’s disease recurrence: results from a prospective mono-centric trial M. Noben1 *, A. de Buck van Overstraeten2 , S. Lockton3 , G. De Hertogh4 , F. Princen3 , A. Wolthuis2 , G. Van Assche1 , S. Vermeire1 , S. Singh3 , A. D’Hoore2 , M. Ferrante1 . 1 University Hospitals Leuven, Department of Gastroenterology, Leuven, Belgium, 2 University Hospitals Leuven, Department of Abdominal Surgery, Leuven, Belgium, 3 Prometheus Laboratories, Department of Research and Development, San Diego, United States, 4 University Hospitals Leuven, Department of Pathology, Leuven, Belgium Background: Preventing postoperative endoscopic (ER) and clinical recurrence (CR) remains a challenging issue in patients with Crohn’s disease (CD) undergoing an intestinal resection. Several clinical and histological risk factors have been identified, and may guide postoperative prophylactic CD therapy. We evaluated if pre-operative serological markers could strengthen prediction of postoperative ER and CR. Methods: The study population consisted of 100 consecutive patients (41 males, 27 active smokers, median age 41.7 years) undergoing an ileal resection with ileocolonic anastomosis for refractory CD, in whom a serum sample was collected 1 week prior to surgery. All patients underwent a postoperative endoscopic evaluation at 6 months. The primary endpoint, ER, was defined as a postoperative endoscopic recurrence score of i3 or i4. Secondary endpoints included time to clinical recurrence. Sera were analysed blindly at Prometheus laboratories for the expression of ASCA IgA and IgG antibodies, three different anti-flagellin antibodies (CBir1, Fla2 and FlaX), OmpC, and pANCA. The Q3 value of each individual marker in this dataset was defined as the cut-off point. Predictors of both ER and CR in univariate analyses were included in the binary logistic and Cox regression analysis. Results: Twenty-five patients developed ER at 6 months. Fla2 > 66 EU [Odds ratio 3.0 (95% confidence interval 1.1 8.7), p = 0.037], and active smoking [3.1 (1.1 8.8), p = 0.029], were independently associated with ER. During a median follow-up of 23.6 months, 29 patients developed a CR, with Fla2 > 66 EU [2.2 (1.0 4.6), p = 0.041], pANCA positivity [2.5 (1.2 5.4), p = 0.016], and active smoking [2.6 (1.2 5.5), p = 0.011], as independent risk factors. A cumulative risk score was developed by combining 3 risk factors (Fla2 > 66 EU, pANCA positivity, and active smoking). Based on this cumulative risk score, we could observe a significant and gradual increased risk of both ER (Figure 1, linear-by-linear p < 0.001) and CR (Figure 2, LogRank p < 0.001).
Figure 1. Endoscopic recurrence at month 6.