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P107 Usefulness of a rapid test for fecal calprotectin as predictor of relapse in Crohn's disease patients under maintenance treatment with adalimumab
Clinical: Diagnosis & outcome P107 Usefulness of a rapid test for fecal calprotectin as predictor of relapse in Crohn’s disease patients under maintenance treatment with adalimumab R. Ferreiro *, M. Barreiro-de Acosta, A. Lorenzo, J.E. Dominguez-Mu˜ noz. University Hospital Santiago de Compostela, Gastroenterology, Santiago, Spain Background: Predicting relapse in Crohn’s disease (CD) patients by measuring non-invasive biomarkers could allow for early changes of treatment. Data are scarce regarding the usefulness of monitoring with calprotectin to predict relapse. The aim of the study was to evaluate the predictive value of a rapid test of fecal calprotectin to predict for flares in CD patients under maintenance treatment with adalimumab (ADA). Methods: A prospective, observationalcohort study was designed. Inclusion criteria were CD patients in clinical remission for at least six months under a continuous standard dose of 40 mg/eow ADA therapy. Fresh faecal calprotectin was measured using a rapid test (Quantum blue® ) on the day of the first ADA injection. Quantum blue ® is a rapid test for measuring calprotectin in less than half an hour. Clinical examination was performed during the following 4 months. Relapse was defined as a Harvey Bradshaw score >4. Results are shown as mean±SD and compared by the U-Mann Whitney test. ROC analysis was performed and the diagnostic accuracy was calculated. Results: Thirty patients were included (mean age 40 years, 56.7% female). After the four months follow-up, twentyone (70.0%) patients remained in clinical remission and nine (30.0%) have had a relapse. Fecal calprotectin concentration at inclusion was significantly higher in those patients who relapsed during the follow-up (803±514 mg/g) than in those who maintained in remission (95±104 mg/g) (p < 0.005). The optimal cut-off of fecal calprotectin to predict remission was 204 mg/g according to the ROC analysis. The area under the ROC curve was 0.97 (p < 0.005). Sensitivity, specificity, positive and negative predictive value of fecal calprotectin to predict relapse were 100%, 85.7%, 74.1% and 100%, respectively. Levels of calprotectin were correlated with levels of C-reactive protein (r = 0.51, P < 0.005). After multiple linear regression, we observed that if we made adjustments with other relevant sociodemographic and clinical variables, calprotectin and older age were the most important risk factors for the presence of relapse. Conclusions: In CD patients under ADA maintenance therapy, fecal calprotectin levels allow predicting relapse over the following months with a high accuracy. Low fecal calprotectin levels exclude relapse within at least the following four months, whereas high levels are associated with relapse in three out of each four patients. P108 Towards patient-reported disease severity index in inflammatory bowel disease L. Alrubaiy1,2 *, J. Williams1 , H. Hutchings1 . 1 Swansea University, College of Medicine, Swansea, United Kingdom, 2 Royal Gwent Hospital, Gastroenterology, Newport, United Kingdom Background: Most disease severity indices in inflammatory bowel disease (IBD) were not properly validated. Our aim is to develop the first patient reported clinical disease severity index that is valid, easy obtainable for all IBD patients. Methods: Items were devised through extensive literature review of the clinical severity indices commonly used for ulcerative colitis (UC) and Crohn’s disease (CD). A focus group of IBD specialists reviewed these items to ensure good face and content validity. Psychometric properties were tested on 255 patients with UC and CD to shorten the index. Construct validity was checked using biochemical markers, clinical indices and endoscopic indices.
S107 Results: We found that 8 items account for 98% of the variance of the total score which were: Abdominal pain, stool consistency, blood in stool, stool frequency, general well being, nocturnal symptoms, functional status and urgency. Items that had high item total correlation >0.8 like physician global assessment were removed from the index as they are redundant. Temperature and abdominal mass had a zero variance score and were removed during principle component analysis. Internal consistency (Correlation of items with each other) was acceptable (Cronbach alpha = 0.827). SICSI had good correlation with the CRP, clinical, and endoscopic severity scores (r > 0.5). Test retest and inter-observer reliability was very good (r = 0.9). Conclusions: This is the first validated patient reported clinical severity index in IBD. It is clear that this index will perform well in clinical practice and will be invaluable tool in research. P109 Thiopurines and anti-TNFs after a diagnosis of cancer in patients with inflammatory bowel disease S. Onali *, C. Petruzziello, G. Condino, M. Ascolani, E. Calabrese, E. Lolli, A. Ruffa, F. Pallone, L. Biancone. Universit` a di Roma Tor Vergata, Medicina dei sistemi, cattedra di Gastroenterologia, Roma, Italy Background: The possible role of immunomodulators (IMM) in the development or outcome of cancer in patients with Inflammatory Bowel Disease IBD) is still debated. Whether IBD patients with a previous diagnosis of cancer may be treated with IMM, including anti-TNFs is undefined. In order to address this issue, the outcome of all patients with IBD under regular follow up treated with IMM and/or anti-TNFs after a diagnosis of cancer was evaluated. Methods: In a retrospective cohort study, clinical characteristics of all IBD pts under regular follow up at our tertiary IBD center from 2000 to 2013, with a certain diagnosis of cancer were reviewed. Among these subgroup of pts with both IBD and cancer, only pts treated with IMM and/or anti-TNFs after the diagnosis of cancer were considered. Parameters considered: 1. Type of IBD (Crohn’s Disease, CD vs Ulcerative Colitis, UC); 2. Gender; 3. Age at diagnosis of IBD; 4. Age at diagnosis of cancer (yr); 5. Type of IMM (Azathioprine, AZA, 6-mercapopurine, 6MP, others) or anti-TNF (Infliximab, IFX, Adalimumab, AD, others); 6. Duration of IBD at diagnosis of cancer; 7. Time interval between diagnosis of cancer and IMM; 8. Follow up duration after diagnosis of cancer; 9. Type of cancer. Statistic. Data expressed as median (range). Results: During 12 yrs period, a history of cancer was recorded in 82 IBD pts. Among these 82 IBD pts with cancer, 15 (18.2%) were treated with IMM for IBD after the diagnosis of cancer. IBD group included 12 CD and 3 UC, (8 M, 5 F), with a median age at diagnosis of cancer of 41 (range 21 69). The age at diagnosis of IBD was 27 (range 12 66), and the duration of IBD at time of diagnosis of cancer was 10 (range 1 38). IMM used after the diagnosis of cancer included thiopurines in 12 (AZA n = 8; 6MP n = 4), anti-TNFs in 3 (ADA n = 0.2; local IFX n = 1). Among the 15 IBD pts treated with IMM after the diagnosis of neoplasia, cancer involved: thyroid (n = 4), skin (n = 2; 1 basal cell carcinoma, 1 spinal cell carcinoma); breast (n = 2), colon (n = 2), prostatic cancer (n = 2) lymphoma (HL n = 1), seminoma (n = 1), carcinoid of the appendix (n = 1). The time interval between the diagnosis of cancer and IMM was 6 yrs (range 1 26). After a median follow up from the diagnosis of cancer of 10 yrs (range 3 30), none of the 15 IBD pts treated with IMM after the diagnosis of cancer showed recurrence of cancer, or had a cancer-related death. Death was observed in 1 CD pt, due to cirrhosis.
S107 Results: We found that 8 items account for 98% of the variance of the total score which were: Abdominal pain, stool consistency, blood in stool, stool frequency, general well being, nocturnal symptoms, functional status and urgency. Items that had high item total correlation >0.8 like physician global assessment were removed from the index as they are redundant. Temperature and abdominal mass had a zero variance score and were removed during principle component analysis. Internal consistency (Correlation of items with each other) was acceptable (Cronbach alpha = 0.827). SICSI had good correlation with the CRP, clinical, and endoscopic severity scores (r > 0.5). Test retest and inter-observer reliability was very good (r = 0.9). Conclusions: This is the first validated patient reported clinical severity index in IBD. It is clear that this index will perform well in clinical practice and will be invaluable tool in research. P109 Thiopurines and anti-TNFs after a diagnosis of cancer in patients with inflammatory bowel disease S. Onali *, C. Petruzziello, G. Condino, M. Ascolani, E. Calabrese, E. Lolli, A. Ruffa, F. Pallone, L. Biancone. Universit` a di Roma Tor Vergata, Medicina dei sistemi, cattedra di Gastroenterologia, Roma, Italy Background: The possible role of immunomodulators (IMM) in the development or outcome of cancer in patients with Inflammatory Bowel Disease IBD) is still debated. Whether IBD patients with a previous diagnosis of cancer may be treated with IMM, including anti-TNFs is undefined. In order to address this issue, the outcome of all patients with IBD under regular follow up treated with IMM and/or anti-TNFs after a diagnosis of cancer was evaluated. Methods: In a retrospective cohort study, clinical characteristics of all IBD pts under regular follow up at our tertiary IBD center from 2000 to 2013, with a certain diagnosis of cancer were reviewed. Among these subgroup of pts with both IBD and cancer, only pts treated with IMM and/or anti-TNFs after the diagnosis of cancer were considered. Parameters considered: 1. Type of IBD (Crohn’s Disease, CD vs Ulcerative Colitis, UC); 2. Gender; 3. Age at diagnosis of IBD; 4. Age at diagnosis of cancer (yr); 5. Type of IMM (Azathioprine, AZA, 6-mercapopurine, 6MP, others) or anti-TNF (Infliximab, IFX, Adalimumab, AD, others); 6. Duration of IBD at diagnosis of cancer; 7. Time interval between diagnosis of cancer and IMM; 8. Follow up duration after diagnosis of cancer; 9. Type of cancer. Statistic. Data expressed as median (range). Results: During 12 yrs period, a history of cancer was recorded in 82 IBD pts. Among these 82 IBD pts with cancer, 15 (18.2%) were treated with IMM for IBD after the diagnosis of cancer. IBD group included 12 CD and 3 UC, (8 M, 5 F), with a median age at diagnosis of cancer of 41 (range 21 69). The age at diagnosis of IBD was 27 (range 12 66), and the duration of IBD at time of diagnosis of cancer was 10 (range 1 38). IMM used after the diagnosis of cancer included thiopurines in 12 (AZA n = 8; 6MP n = 4), anti-TNFs in 3 (ADA n = 0.2; local IFX n = 1). Among the 15 IBD pts treated with IMM after the diagnosis of neoplasia, cancer involved: thyroid (n = 4), skin (n = 2; 1 basal cell carcinoma, 1 spinal cell carcinoma); breast (n = 2), colon (n = 2), prostatic cancer (n = 2) lymphoma (HL n = 1), seminoma (n = 1), carcinoid of the appendix (n = 1). The time interval between the diagnosis of cancer and IMM was 6 yrs (range 1 26). After a median follow up from the diagnosis of cancer of 10 yrs (range 3 30), none of the 15 IBD pts treated with IMM after the diagnosis of cancer showed recurrence of cancer, or had a cancer-related death. Death was observed in 1 CD pt, due to cirrhosis.