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Su1230 Venous Thromboembolism Prophylaxis Use in Patients Admitted With Severe Ulcerative Colitis
AGA Abstracts
therapy for 6 months prior to drug withdrawal, and minimum 12 months follow-up. The primary outcome was disease relapse requiring AZA reinitiation, steroids or colectomy within 12 months of AZA/MP withdrawal, with secondary outcome assessed at 24 months. Clinical/ laboratory predictors of relapse were sought. Results Data was obtained on 97 patients with CD and 78 with UC. Median age at diagnosis was 26y (interquartile range [IQR] 20-38), and 49% were female. Median duration of thiopurine use was 73 months (IQR 54-104). Median duration of follow-up was 39 months (IQR 24-65 months). CD was associated with a significantly higher risk of relapse than UC on Kaplan Meier analysis (Figure 1, p=0.024). The moderate-severe relapse rate for 12 months was 27% for CD and 14% for UC. For 24 months, relapse rates were 41% for CD and 28% for UC. Elevated CRP was predictive of relapse at 12 months for CD (0=0.017), while elevated platelet count was predictive of relapse at 24 months for UC (0.021). Retreatment with a thiopurine after relapse was successful in 34/39 (87%) for CD and 17/18 (94%) cases for UC. Conclusion Relapse rates after withdrawal of a thiopurine are high, particularly for CD, and predicting this remains difficult. The findings regarding CRP and CD in this data highlight the importance of ensuring patients are in deep remission prior to drug withdrawal. Further studies should evaluate the role of faecal calprotectin in this.
Su1230 Venous Thromboembolism Prophylaxis Use in Patients Admitted With Severe Ulcerative Colitis Julie Pleet, Byron P. Vaughn, Alan C. Moss, Adam S. Cheifetz Introduction: Fifteen percent of patients with ulcerative colitis (UC) experience a severe flare requiring hospitalization. Hospitalized patients with ulcerative colitis are approximately twice as likely to develop venous thromboembolism (VTE) when compared to controls. Clinical guidelines recommend use of VTE prophylaxis for patients with acute ulcerative colitis; however, few studies exist examining the appropriate use of VTE prophylaxis. Aim: To determine the rate of appropriate venous thromboembolism prophylaxis use in a cohort of hospitalized patients with severe ulcerative colitis. Methods: The cohort was obtained utilizing the online medical records at Beth Israel Deaconess Medical Center, a large, urban academic tertiary care center. Patients were identified by International Classification of Diseases 9th Edition (ICD9) Clinical Modification discharge code with a primary diagnosis of 556.x between the years of 2005 and 2012. Electronic physician orders and scanned nursing records were reviewed to detect the appropriate ordering and administration of VTE prophylaxis. The primary outcome was the incidence of appropriately ordered VTE prophylaxis, including use of unfractionated sub-cutaneous heparin, low molecular weight heparin, intravenous heparin, warfarin, fondaparinux, and argatroban. Secondary outcomes include the administration of prophylaxis and patient related factors associated with failure to order prophylaxis. Significance for binary variable was assessed with Chi squared or fisher exact test as appropriate. Results: One hundred 100 unique hospital admissions with a primary diagnosis of ulcerative colitis were evaluated. Only 49% had a physician order for prophylactic anticoagulation. The vast majority (94%) of these orders were for unfractionated sub-cutaneous heparin. Nursing orders were available in 86% (42/49) of the above cases. In 69% of these cases (29/42), subcutaneous heparin was given less than 25% of the time. In only 19% of cases (8/42) was the dose given over 50% of the time. Age (p = 0.9), blood in stool (p = 0.8), and hemoglobin (p = 0.8) were not associated with failure to order prophylaxis. Conclusions: Despite the recommendation that patients admitted to the hospital with severe ulcerative colitis should be given venous thrombosis prophylaxis, a large number of patients are not receiving appropriate treatment. In just over half of the cases, physicians are not ordering appropriate VTE prophylaxis. When orders for VTE prophylaxis are written patients are often not receiving an adequate dose. Further study of physician awareness and barriers to appropriate VTE prophylaxis is needed to increase adherence to recommendations. Su1231 Pre-Treatment 25-Hydroxy Vitamin D Levels and Response to Anti-Tumor Necrosis Factor Alpha Therapy in Crohns Disease and Ulcerative Colitis Zachary A. Zator, Stephanie Cantu, Gauree G. Konijeti, Deanna D. Nguyen, Jenny Sauk, Vijay Yajnik, Ashwin N. Ananthakrishnan
Figure 1 Su1229
Introduction: Emerging evidence supports an immunologic role for vitamin D [25(OH)D] in Inflammatory Bowel Disease (IBD). Vitamin D deficiency increases the risk of developing Crohn's disease (CD) and may be associated with greater disease activity. While animal models suggest a therapeutic effect of vitamin D supplementation on colitis, the role that vitamin D plays in the treatment of IBD in humans remains unknown. Laboratory evidence demonstrates that vitamin D administration suppresses expression of TNF-alpha related genes in the colon, suggesting potential for synergy with anti-TNF therapy. Thus, we performed this study to examine if pre-treatment vitamin D status influences response to anti-TNF therapy in patients with CD or ulcerative colitis (UC). Methods: This was a retrospective single-center study comprising all IBD patients who had 25(OH)D level checked ≤ 6 months prior to initiating anti-TNF therapy. Our main predictor variable was sufficient plasma 25(OH)D defined as a level . 30 ng/mL. Cox proportional hazards model adjusting for potential confounders was used to identify independent effect of vitamin D on treatment cessation. Several planned subgroup analyses were performed. Results: Our study included 138 IBD patients (107 CD) with a median age of diagnosis of 22 years and disease duration of 8 years. The median index 25(OH)D level was 29 (IQR 21-36ng/mL) measured at a median of 1 month prior to anti-TNF initiation. The most common anti-TNF was adalimumab (52%), followed by infliximab (38%); one-third of the patients (34%) had prior exposure to anti-TNF therapy. Just under half the cohort had sufficient levels of vitamin D (43%). On univariate analysis, patients with insufficient vitamin D levels demonstrated a trend towards earlier cessation of anti-TNF (HR 1.38; 95% CI 0.83-2.28) compared to those with sufficient levels. This was more striking in those who were not on supplemental vitamin D therapy at the time of the index 25(OH)D measurement (HR 2.04; 95% CI 0.94-4.45). On multivariate analysis, insufficient vitamin D continued to demonstrate earlier cessation of anti-TNF therapy (HR 1.58, 95% CI 0.94 - 2.66, p=0.08), particularly among those with CD (HR 1.67, 95% CI 0.92 - 3.04, p=0.09) and patients not on vitamin D supplementation at the time of index measurement (HR 2.42; 95% CI 1.08-5.42). Conclusion: Our findings suggest that insufficient vitamin D levels may influence durability of anti-TNF induction and maintenance therapy, though our findings in the whole cohort did not reach statistical significance. Larger cohort studies and clinical trials of supplemental vitamin D use with disease activity as an endpoint may be warranted.
Predictors of Response to Infliximab As Salvage Therapy for Severe Steroid Refractory Ulcerative Colitis Byron P. Vaughn, Julie Pleet, Adam S. Cheifetz, Alan C. Moss Introduction: Infliximab is one option for salvage therapy for hospitalized patients with a severe flare of Ulcerative colitis (UC). Predicting which patients will respond to infliximab would help physicians in determining appropriate salvage therapy. Markers such as Creactive protein (CRP), albumin and hemoglobin have been proposed as predictors of response to infliximab. However, controversy remains as to the best way to identify patients who will respond to salvage therapy with infliximab. Aims: To assess serologic markers (i.e. albumin, CRP and hemoglobin) as predictors of response to infliximab in steroid refractory UC. Methods: We conducted a retrospective cohort study of all patients admitted between 2006 and 2012 to a large tertiary care center with an International Classification of Disease9 (ICD-9) code of Ulcerative Colitis (556.x) and received 5mg/kg of infliximab in the hospital. Patient's charts were reviewed and were excluded if they had Crohn's disease or infectious colitis. Data was collected regarding clinical course. Admission hemoglobin, CRP, and albumin were used as predictors of clinical response, defined as the treating physician's global assessment of improvement. Logistic regression was used to determine significance for continuous variables. Statistical analysis was performed with JMP-10. Results: We identified 22 patients who were given 5mg/kg infliximab for steroid refractory UC. Eighteen (82%) had a clinical response to infliximab during that hospitalization. The majority of patients had pancolitis (41%), followed by extensive disease (32%), and left sided disease (23%). The only patient factor associated with clinical improvement was age; with those improving having an older average age (43 v. 27, p = 0.03). There was no significant difference in clinical improvement based on serologic markers (table 1). There were two patients that had a CRP of . 100 at admit. Both of these patients had an initial response to infliximab, but went on to colectomy within 6 months. Conclusions: Despite other studies showing CRP, albumin and hemoglobin can predict response to infliximab; there was no correlation between these markers and clinical improvement after infliximab in our study population. While a very high CRP may have use as predictor of colectomy, novel biomarkers are needed to predict response to infliximab. Table 1: Potential predictors associated with improvement after salvage therapy with infliximab
Su1232 Effect of Early Induction With Thiopurine Immunomodulator Treatment on Long-Term Clinical Remission in Patients With Crohn's Disease Takuya Yoshino, Hiroshi Nakase, Minoru Matsuura, Tsutomu Chiba Background and Aim: Recently, early induction of immunomoduators has been considered to be effective for Crohn's disease (CD). However, the effect of early induction of immunomodulators on long-term clinical outcome in patients with CD remains unclear. The aim of this study is to evaluate the effect of early induction of thiopurines on long-term clinical remission for patients with CD. Method: Of 148 patients with CD (mean age 30 years (1471 years); male: 114, female: 34) followed at our institution, we retrospectively analyzed a subset of 48 patients (32.4%) treated with thiopurines alone for maintenance after achieving
Hb: hemoglobin; SD: standard deviation; IQR: inter-quartile range (25%, 75%)
AGA Abstracts
S-434
therapy for 6 months prior to drug withdrawal, and minimum 12 months follow-up. The primary outcome was disease relapse requiring AZA reinitiation, steroids or colectomy within 12 months of AZA/MP withdrawal, with secondary outcome assessed at 24 months. Clinical/ laboratory predictors of relapse were sought. Results Data was obtained on 97 patients with CD and 78 with UC. Median age at diagnosis was 26y (interquartile range [IQR] 20-38), and 49% were female. Median duration of thiopurine use was 73 months (IQR 54-104). Median duration of follow-up was 39 months (IQR 24-65 months). CD was associated with a significantly higher risk of relapse than UC on Kaplan Meier analysis (Figure 1, p=0.024). The moderate-severe relapse rate for 12 months was 27% for CD and 14% for UC. For 24 months, relapse rates were 41% for CD and 28% for UC. Elevated CRP was predictive of relapse at 12 months for CD (0=0.017), while elevated platelet count was predictive of relapse at 24 months for UC (0.021). Retreatment with a thiopurine after relapse was successful in 34/39 (87%) for CD and 17/18 (94%) cases for UC. Conclusion Relapse rates after withdrawal of a thiopurine are high, particularly for CD, and predicting this remains difficult. The findings regarding CRP and CD in this data highlight the importance of ensuring patients are in deep remission prior to drug withdrawal. Further studies should evaluate the role of faecal calprotectin in this.
Su1230 Venous Thromboembolism Prophylaxis Use in Patients Admitted With Severe Ulcerative Colitis Julie Pleet, Byron P. Vaughn, Alan C. Moss, Adam S. Cheifetz Introduction: Fifteen percent of patients with ulcerative colitis (UC) experience a severe flare requiring hospitalization. Hospitalized patients with ulcerative colitis are approximately twice as likely to develop venous thromboembolism (VTE) when compared to controls. Clinical guidelines recommend use of VTE prophylaxis for patients with acute ulcerative colitis; however, few studies exist examining the appropriate use of VTE prophylaxis. Aim: To determine the rate of appropriate venous thromboembolism prophylaxis use in a cohort of hospitalized patients with severe ulcerative colitis. Methods: The cohort was obtained utilizing the online medical records at Beth Israel Deaconess Medical Center, a large, urban academic tertiary care center. Patients were identified by International Classification of Diseases 9th Edition (ICD9) Clinical Modification discharge code with a primary diagnosis of 556.x between the years of 2005 and 2012. Electronic physician orders and scanned nursing records were reviewed to detect the appropriate ordering and administration of VTE prophylaxis. The primary outcome was the incidence of appropriately ordered VTE prophylaxis, including use of unfractionated sub-cutaneous heparin, low molecular weight heparin, intravenous heparin, warfarin, fondaparinux, and argatroban. Secondary outcomes include the administration of prophylaxis and patient related factors associated with failure to order prophylaxis. Significance for binary variable was assessed with Chi squared or fisher exact test as appropriate. Results: One hundred 100 unique hospital admissions with a primary diagnosis of ulcerative colitis were evaluated. Only 49% had a physician order for prophylactic anticoagulation. The vast majority (94%) of these orders were for unfractionated sub-cutaneous heparin. Nursing orders were available in 86% (42/49) of the above cases. In 69% of these cases (29/42), subcutaneous heparin was given less than 25% of the time. In only 19% of cases (8/42) was the dose given over 50% of the time. Age (p = 0.9), blood in stool (p = 0.8), and hemoglobin (p = 0.8) were not associated with failure to order prophylaxis. Conclusions: Despite the recommendation that patients admitted to the hospital with severe ulcerative colitis should be given venous thrombosis prophylaxis, a large number of patients are not receiving appropriate treatment. In just over half of the cases, physicians are not ordering appropriate VTE prophylaxis. When orders for VTE prophylaxis are written patients are often not receiving an adequate dose. Further study of physician awareness and barriers to appropriate VTE prophylaxis is needed to increase adherence to recommendations. Su1231 Pre-Treatment 25-Hydroxy Vitamin D Levels and Response to Anti-Tumor Necrosis Factor Alpha Therapy in Crohns Disease and Ulcerative Colitis Zachary A. Zator, Stephanie Cantu, Gauree G. Konijeti, Deanna D. Nguyen, Jenny Sauk, Vijay Yajnik, Ashwin N. Ananthakrishnan
Figure 1 Su1229
Introduction: Emerging evidence supports an immunologic role for vitamin D [25(OH)D] in Inflammatory Bowel Disease (IBD). Vitamin D deficiency increases the risk of developing Crohn's disease (CD) and may be associated with greater disease activity. While animal models suggest a therapeutic effect of vitamin D supplementation on colitis, the role that vitamin D plays in the treatment of IBD in humans remains unknown. Laboratory evidence demonstrates that vitamin D administration suppresses expression of TNF-alpha related genes in the colon, suggesting potential for synergy with anti-TNF therapy. Thus, we performed this study to examine if pre-treatment vitamin D status influences response to anti-TNF therapy in patients with CD or ulcerative colitis (UC). Methods: This was a retrospective single-center study comprising all IBD patients who had 25(OH)D level checked ≤ 6 months prior to initiating anti-TNF therapy. Our main predictor variable was sufficient plasma 25(OH)D defined as a level . 30 ng/mL. Cox proportional hazards model adjusting for potential confounders was used to identify independent effect of vitamin D on treatment cessation. Several planned subgroup analyses were performed. Results: Our study included 138 IBD patients (107 CD) with a median age of diagnosis of 22 years and disease duration of 8 years. The median index 25(OH)D level was 29 (IQR 21-36ng/mL) measured at a median of 1 month prior to anti-TNF initiation. The most common anti-TNF was adalimumab (52%), followed by infliximab (38%); one-third of the patients (34%) had prior exposure to anti-TNF therapy. Just under half the cohort had sufficient levels of vitamin D (43%). On univariate analysis, patients with insufficient vitamin D levels demonstrated a trend towards earlier cessation of anti-TNF (HR 1.38; 95% CI 0.83-2.28) compared to those with sufficient levels. This was more striking in those who were not on supplemental vitamin D therapy at the time of the index 25(OH)D measurement (HR 2.04; 95% CI 0.94-4.45). On multivariate analysis, insufficient vitamin D continued to demonstrate earlier cessation of anti-TNF therapy (HR 1.58, 95% CI 0.94 - 2.66, p=0.08), particularly among those with CD (HR 1.67, 95% CI 0.92 - 3.04, p=0.09) and patients not on vitamin D supplementation at the time of index measurement (HR 2.42; 95% CI 1.08-5.42). Conclusion: Our findings suggest that insufficient vitamin D levels may influence durability of anti-TNF induction and maintenance therapy, though our findings in the whole cohort did not reach statistical significance. Larger cohort studies and clinical trials of supplemental vitamin D use with disease activity as an endpoint may be warranted.
Predictors of Response to Infliximab As Salvage Therapy for Severe Steroid Refractory Ulcerative Colitis Byron P. Vaughn, Julie Pleet, Adam S. Cheifetz, Alan C. Moss Introduction: Infliximab is one option for salvage therapy for hospitalized patients with a severe flare of Ulcerative colitis (UC). Predicting which patients will respond to infliximab would help physicians in determining appropriate salvage therapy. Markers such as Creactive protein (CRP), albumin and hemoglobin have been proposed as predictors of response to infliximab. However, controversy remains as to the best way to identify patients who will respond to salvage therapy with infliximab. Aims: To assess serologic markers (i.e. albumin, CRP and hemoglobin) as predictors of response to infliximab in steroid refractory UC. Methods: We conducted a retrospective cohort study of all patients admitted between 2006 and 2012 to a large tertiary care center with an International Classification of Disease9 (ICD-9) code of Ulcerative Colitis (556.x) and received 5mg/kg of infliximab in the hospital. Patient's charts were reviewed and were excluded if they had Crohn's disease or infectious colitis. Data was collected regarding clinical course. Admission hemoglobin, CRP, and albumin were used as predictors of clinical response, defined as the treating physician's global assessment of improvement. Logistic regression was used to determine significance for continuous variables. Statistical analysis was performed with JMP-10. Results: We identified 22 patients who were given 5mg/kg infliximab for steroid refractory UC. Eighteen (82%) had a clinical response to infliximab during that hospitalization. The majority of patients had pancolitis (41%), followed by extensive disease (32%), and left sided disease (23%). The only patient factor associated with clinical improvement was age; with those improving having an older average age (43 v. 27, p = 0.03). There was no significant difference in clinical improvement based on serologic markers (table 1). There were two patients that had a CRP of . 100 at admit. Both of these patients had an initial response to infliximab, but went on to colectomy within 6 months. Conclusions: Despite other studies showing CRP, albumin and hemoglobin can predict response to infliximab; there was no correlation between these markers and clinical improvement after infliximab in our study population. While a very high CRP may have use as predictor of colectomy, novel biomarkers are needed to predict response to infliximab. Table 1: Potential predictors associated with improvement after salvage therapy with infliximab
Su1232 Effect of Early Induction With Thiopurine Immunomodulator Treatment on Long-Term Clinical Remission in Patients With Crohn's Disease Takuya Yoshino, Hiroshi Nakase, Minoru Matsuura, Tsutomu Chiba Background and Aim: Recently, early induction of immunomoduators has been considered to be effective for Crohn's disease (CD). However, the effect of early induction of immunomodulators on long-term clinical outcome in patients with CD remains unclear. The aim of this study is to evaluate the effect of early induction of thiopurines on long-term clinical remission for patients with CD. Method: Of 148 patients with CD (mean age 30 years (1471 years); male: 114, female: 34) followed at our institution, we retrospectively analyzed a subset of 48 patients (32.4%) treated with thiopurines alone for maintenance after achieving
Hb: hemoglobin; SD: standard deviation; IQR: inter-quartile range (25%, 75%)
AGA Abstracts
S-434