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Mo1179 Efficacy and Safety of Anti-TNF Therapy in Elderly Patients With Inflammatory Bowel Disease Triana Lobatón Ortega, Severine Vermeire, Vera Ballet, Paul J. Rutgeerts, Gert A. Van Assche, Marc Ferrante INTRODUCTION: The general increased life expectancy is reflected in the age of patients with inflammatory bowel disease (IBD). The knowledge about efficacy and safety of anti- tumor necrosis factor (TNF) therapy in elderly is scarce and conflicting. Our objectives were to assess the efficacy and safety of anti-TNF therapy in elderly patients taking into account eventual comorbidity. METHODS: In this retrospective single-centre study we compared 63 IBD patients initiating anti-TNF treatment at age 65 years (cases) to 118 IBD patients initiating anti-TNF at age <65 years (control 1) and 70 anti-TNF Naive IBD patients treated with azathioprine (AZA) and/or corticosteroids (CS) 65 years (control 2). Both control groups were matched to the case-group for type of IBD (Crohn's disease or ulcerative colitis), follow up, disease duration, and in case of control 1 for type of anti-TNF (adalimumab or infliximab) . Comorbidity was assessed using the Charlson Comorbidity Index (CCI). Both efficacy and safety of treatment were analyzed. RESULTS: Baseline characteristics are collected in Table 1. The short-term clinical response (CR) to anti-TNF was significantly lower in the elderly than in younger patients (67% vs. 87%; P<0.001). Primary responders, achieved a similar long-term outcome regardless of age. Considering all patients with a CCI =0, age of65 years remained a risk factor for lower short-term CR (62% vs. 87%; P<0.001). In the univariate analysis cases had numerically more infections, surgeries, severe adverse events (SAE), malignancies and mortality (Table 1). In the multivariate analysis age remained an independent risk factor for absence of short-term CR [ odds ratio 3.4 (95% confidence interval (1.4-6.6), P=0.005), severe infection [4.2 (1.2-14.4), P=0.025] and SAE [2 (1.1- 3.7), P=0.029]. Considering the 3 groups, age65 and CCI> 0 were risk factors for malignancy and mortality. CONCLUSION: Elderly patients treated with anti-TNF have a lower rate of clinical response (regardless of their comorbidity). The rate of adverse events is higher in elderly patients but especially in those with a higher comorbidity. Mo1180 Sustained Leukopenia Not Observed in Patients With Thiopurine-Associated Lymphoma and Ulcerative Colitis Elisabeth B. Cole, Ali Abbas, Yordanka N. Koleva, Nabeel Khan Background: Immunomodulators such as thiopurines (azathioprine and 6-mercaptopurine) are used to induce and maintain steroid-free remission in patients with ulcerative colitis (UC). However, despite their efficacy, patients with UC treated with thiopurines are at a four-fold increase in the risk of lymphoproliferative disorders compared to UC patients who have not been treated with thiopurines. A previous study suggested that patients with sustained leukopenia who are taking 6-mercaptopurine for inflammatory bowel disease may have an increased risk of hematologic malignancy. In order to further explore this association, our aim was to assess the frequency of sustained leukopenia during the year preceding diagnosis in a cohort of UC patients who developed lymphomas while being concurrently treated with thiopurines. Methods: We obtained nationwide data from the Veterans Affairs (VA) health care system from 2001 to 2011. We performed a retrospective cohort study, analyzing data on 36,891 patients from their date of diagnosis of UC in the VA health care system to a diagnosis of lymphomas or October 1, 2011. Thiopurine exposure was assessed using the VA pharmacy database. Patients who developed lymphomas were identified based on ICD-9 codes and confirmed by manual chart review. Follow-up was concluded at the time of development of lymphoma. All available values from complete blood counts (CBC) S-579 AGA Abstracts performed during the year prior to diagnosis of lymphoma were abstracted and analyzed. Leukopenia was considered to be a leukocyte count of 4.0x103/μL or less. Results: Of the 4,734 patients with UC treated with thiopurines, 18 patients developed lymphomas while being concurrently treated with thiopurines. The mean and median number of CBCs drawn per patient for hematologic monitoring in the year prior to diagnosis of lymphoma were 4 and 4, respectively. The mean leukocyte count for all patients across all months was 6.8x103/ μL. One patient developed sustained leukopenia, with a leukocyte count range between 2.9x103/μL and 3.5x103/μL during the seven months prior to lymphoma diagnosis. All other patients did not have leukopenia in the year prior to lymphoma diagnosis. Conclusion: Less than ten percent of patients being treated with thiopurines developed leukopenia in the year prior to diagnosis. This suggests that development of leukopenia may not be an indicator of impending lymphoproliferative disorders in UC patients being treated with thio- purines. Mo1181 Anti-TNF Therapy in Inflammatory Bowel Disease: Predictors of Weight Gain and Development of Obesity Anish Patel, Yelena Zadvornova, Daniel Stein, Amar S. Naik, Kari Best, Kathleen Idstein, Benson T. Massey, Lilani P. Perera Background: Anti-TNF (ATNF) agents have been successful in treating a wide range of inflammatory conditions, including refractory inflammatory bowel disease [(IBD) ulcerative colitis (UC) and Crohn's disease (CD)]. While only a few studies have assessed weight gain in IBD patients (pts), the issue has more thoroughly evaluated in the context of other chronic inflammatory diseases including psoriasis, plaque psoriasis, rheumatoid arthritis, and spondylarthropathy. Study aims were to evaluate the trend of weight gain over time on ATNF therapy (ATNFT) and to identify predictors of weight gain on ATNFT. Methods: A retrospective chart review of IBD pts aged >18 yrs that have been on ATNF for at least 6 months of therapy were included. Age, gender, ethnicity, disease type, disease phenotype and distribution, age at diagnosis, age at initiation of ATNFT, disease duration at the time of ATNF initiation, concomitant IMM, steroids and mesalamines, weight within 6 months before initiation of ATNFT, smoking status (before and after ATNFT) were recorded. Data for patients who gained weight (how much weight gain to be included?) on ATNFT were compared to those who did not to assess for any risk factors that may be predictive of weight gain. Pre-weight and Post-weight BMIs were calculated. Statistical analysis was per- formed using t test and logistic regression. Results: Review of the database identified 449 pts with at least 6 months of ATNF therapy. 318/449 (71%) gained weight (5.6+/-5.4 kg) on ATNFT. Pts who gained weight (WG) were less likely to be on combination therapy, had shorter disease duration at ATNF start, were younger at disease diagnosis, had higher QoL (SIBDQ) and lower disease activity (HB_UCDAI), compared to pts who did not gain weight (NWG). There was no difference in ATNF treatment duration, ATNF number, steroid use, 5 ASA use, disease type, CD phenotype, or CD/UC disease location between groups. There was also no difference in Vit D values, gender, race, smoking habits between groups. WG group had significantly higher proportion of normal and underweight BMIs compared to NWG group. NWG had higher proportion of overweight and obese patients. 5% of patients developed new onset of obesity (BMI > 30). Predictors of WG were shorter disease duration at ATNF start (p 0.007) and ATNF monotherapy (0.025). Linear regression between weight and treatment duration did show significant p-value of 0.000 but R2=0.03 indicating other factors are the main contributors of weight gain rather than ATNF. Conclusions: Weight gain is prevalent on ATNF therapy. Shorter disease duration at ATNF start and ATNF monotherapy were predictive factors of weight gain. While such weight gain may reflect clinical improvement, especially in underweight subjects, the new development of obesity is of clinical concern. AGA Abstracts

Mo1179 Efficacy and Safety of Anti-TNF Therapy in Elderly Patients With Inflammatory Bowel Disease

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Page 1: Mo1179 Efficacy and Safety of Anti-TNF Therapy in Elderly Patients With Inflammatory Bowel Disease

Mo1179

Efficacy and Safety of Anti-TNF Therapy in Elderly Patients WithInflammatory Bowel DiseaseTriana Lobatón Ortega, Severine Vermeire, Vera Ballet, Paul J. Rutgeerts, Gert A. VanAssche, Marc Ferrante

INTRODUCTION: The general increased life expectancy is reflected in the age of patientswith inflammatory bowel disease (IBD). The knowledge about efficacy and safety of anti-tumor necrosis factor (TNF) therapy in elderly is scarce and conflicting. Our objectives wereto assess the efficacy and safety of anti-TNF therapy in elderly patients taking into accounteventual comorbidity. METHODS: In this retrospective single-centre study we compared63 IBD patients initiating anti-TNF treatment at age ≥ 65 years (cases) to 118 IBD patientsinitiating anti-TNF at age <65 years (control 1) and 70 anti-TNF Naive IBD patients treatedwith azathioprine (AZA) and/or corticosteroids (CS) ≥65 years (control 2). Both controlgroups were matched to the case-group for type of IBD (Crohn's disease or ulcerative colitis),follow up, disease duration, and in case of control 1 for type of anti-TNF (adalimumab orinfliximab) . Comorbidity was assessed using the Charlson Comorbidity Index (CCI). Bothefficacy and safety of treatment were analyzed. RESULTS: Baseline characteristics are collectedin Table 1. The short-term clinical response (CR) to anti-TNF was significantly lower in theelderly than in younger patients (67% vs. 87%; P<0.001). Primary responders, achieved asimilar long-term outcome regardless of age. Considering all patients with a CCI =0, ageof≥ 65 years remained a risk factor for lower short-term CR (62% vs. 87%; P<0.001). Inthe univariate analysis cases had numerically more infections, surgeries, severe adverse events(SAE), malignancies and mortality (Table 1). In the multivariate analysis age remained anindependent risk factor for absence of short-term CR [ odds ratio 3.4 (95% confidenceinterval (1.4-6.6), P=0.005), severe infection [4.2 (1.2-14.4), P=0.025] and SAE [2 (1.1-3.7), P=0.029]. Considering the 3 groups, age≥65 and CCI> 0 were risk factors for malignancyand mortality. CONCLUSION: Elderly patients treated with anti-TNF have a lower rate ofclinical response (regardless of their comorbidity). The rate of adverse events is higher inelderly patients but especially in those with a higher comorbidity.

Mo1180

Sustained Leukopenia Not Observed in Patients With Thiopurine-AssociatedLymphoma and Ulcerative ColitisElisabeth B. Cole, Ali Abbas, Yordanka N. Koleva, Nabeel Khan

Background: Immunomodulators such as thiopurines (azathioprine and 6-mercaptopurine)are used to induce and maintain steroid-free remission in patients with ulcerative colitis(UC). However, despite their efficacy, patients with UC treated with thiopurines are at afour-fold increase in the risk of lymphoproliferative disorders compared to UC patients whohave not been treated with thiopurines. A previous study suggested that patients withsustained leukopenia who are taking 6-mercaptopurine for inflammatory bowel disease mayhave an increased risk of hematologic malignancy. In order to further explore this association,our aim was to assess the frequency of sustained leukopenia during the year precedingdiagnosis in a cohort of UC patients who developed lymphomas while being concurrentlytreated with thiopurines. Methods: We obtained nationwide data from the Veterans Affairs(VA) health care system from 2001 to 2011. We performed a retrospective cohort study,analyzing data on 36,891 patients from their date of diagnosis of UC in the VA health caresystem to a diagnosis of lymphomas or October 1, 2011. Thiopurine exposure was assessedusing the VA pharmacy database. Patients who developed lymphomas were identified basedon ICD-9 codes and confirmed by manual chart review. Follow-up was concluded at thetime of development of lymphoma. All available values from complete blood counts (CBC)

S-579 AGA Abstracts

performed during the year prior to diagnosis of lymphoma were abstracted and analyzed.Leukopenia was considered to be a leukocyte count of 4.0x103/μL or less. Results: Of the4,734 patients with UC treated with thiopurines, 18 patients developed lymphomas whilebeing concurrently treated with thiopurines. The mean and median number of CBCs drawnper patient for hematologic monitoring in the year prior to diagnosis of lymphoma were 4and 4, respectively. The mean leukocyte count for all patients across all months was 6.8x103/μL. One patient developed sustained leukopenia, with a leukocyte count range between2.9x103/μL and 3.5x103/μL during the seven months prior to lymphoma diagnosis. Allother patients did not have leukopenia in the year prior to lymphoma diagnosis. Conclusion:Less than ten percent of patients being treated with thiopurines developed leukopenia inthe year prior to diagnosis. This suggests that development of leukopenia may not be anindicator of impending lymphoproliferative disorders in UC patients being treated with thio-purines.

Mo1181

Anti-TNF Therapy in Inflammatory Bowel Disease: Predictors of Weight Gainand Development of ObesityAnish Patel, Yelena Zadvornova, Daniel Stein, Amar S. Naik, Kari Best, Kathleen Idstein,Benson T. Massey, Lilani P. Perera

Background: Anti-TNF (ATNF) agents have been successful in treating a wide range ofinflammatory conditions, including refractory inflammatory bowel disease [(IBD) ulcerativecolitis (UC) and Crohn's disease (CD)]. While only a few studies have assessed weight gainin IBD patients (pts), the issue has more thoroughly evaluated in the context of otherchronic inflammatory diseases including psoriasis, plaque psoriasis, rheumatoid arthritis,and spondylarthropathy. Study aims were to evaluate the trend of weight gain over timeon ATNF therapy (ATNFT) and to identify predictors of weight gain on ATNFT. Methods:A retrospective chart review of IBD pts aged >18 yrs that have been on ATNF for at least6 months of therapy were included. Age, gender, ethnicity, disease type, disease phenotypeand distribution, age at diagnosis, age at initiation of ATNFT, disease duration at the timeof ATNF initiation, concomitant IMM, steroids and mesalamines, weight within 6 monthsbefore initiation of ATNFT, smoking status (before and after ATNFT) were recorded. Datafor patients who gained weight (how much weight gain to be included?) on ATNFT werecompared to those who did not to assess for any risk factors that may be predictive ofweight gain. Pre-weight and Post-weight BMIs were calculated. Statistical analysis was per-formed using t test and logistic regression. Results: Review of the database identified 449pts with at least 6 months of ATNF therapy. 318/449 (71%) gained weight (5.6+/-5.4 kg)on ATNFT. Pts who gained weight (WG) were less likely to be on combination therapy,had shorter disease duration at ATNF start, were younger at disease diagnosis, had higherQoL (SIBDQ) and lower disease activity (HB_UCDAI), compared to pts who did not gainweight (NWG). There was no difference in ATNF treatment duration, ATNF number, steroiduse, 5 ASA use, disease type, CD phenotype, or CD/UC disease location between groups.There was also no difference in Vit D values, gender, race, smoking habits between groups.WG group had significantly higher proportion of normal and underweight BMIs comparedto NWG group. NWG had higher proportion of overweight and obese patients. 5% ofpatients developed new onset of obesity (BMI > 30). Predictors of WG were shorter diseaseduration at ATNF start (p 0.007) and ATNF monotherapy (0.025). Linear regression betweenweight and treatment duration did show significant p-value of 0.000 but R2=0.03 indicatingother factors are the main contributors of weight gain rather than ATNF. Conclusions:Weight gain is prevalent on ATNF therapy. Shorter disease duration at ATNF start andATNF monotherapy were predictive factors of weight gain. While such weight gain mayreflect clinical improvement, especially in underweight subjects, the new development ofobesity is of clinical concern.

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