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Su1006 Risk of Relapse After Azathioprine (AZA) Discontinuation in Inflammatory Bowel Disease (IBD) Patients in Maintained Remission
Su1006
AGA Abstracts
Risk of Relapse After Azathioprine (AZA) Discontinuation in Inflammatory Bowel Disease (IBD) Patients in Maintained Remission Marisa Iborra, Julia Herreras, Marta M. Bosca-Watts, Xavier Cortés, Belén Navarro, María Teresa Blázquez Martínez, Galo A. Trejo, Belen Beltran, Pilar Nos The benefits of immunosuppressive therapies on the prevention of relapses have been demonstrated in IBD patients. However, the moment at which AZA could be stopped, after being in a long-term remission, remains controversial. The aim of this study was to identify potential predictors of relapse after AZA discontinuation in IBD patients who presented long-term and sustained remission before AZA removal. Methods: A multicenter study including 55 IBD patients, 33 Crohn`s disease (CD) and 22 ulcerative colitis (UC) patients, who had stopped AZA treatment while in prolonged remission. The following variables were collected: demographic data, the Montreal classification, indication of AZA treatment, steroiddependence and steroid-refractory status, AZA treatment duration and time until relapse. The presence of clinical and/or endoscopic remission and biologic values (C- reactive protein (CRP), fecal calprotectin (FC) and hemoglobin (Hb) levels) at AZA interruption were collected. FC and CRP measurements were assessed at 6 and 12 months in order to monitor whether the remission was maintained. Results: The main characteristics of the population are showed in table 1. Patients had been in remission for a mean time of 3-4 years. No UC patients had received biological therapy before taking AZA, whereas 3 (9.1%) CD patients had been previously treated with anti-TNF. Endoscopic remission was evaluated in 13 UC (59%) and 18 CD (55%) patients. After AZA discontinuation, 19 UC (86%) and 16 CD (49%) patients were treated with high doses of salicylates. Time-to-relapse rate after AZA withdrawal was estimated using the Kaplan-Meier method (figure 1). The median followup time after AZA interruption was 36.7 months; overall relapse was 32% (7 patients) in UC and 33% (11patients) in CD. The cumulative relapse rates at 1, 2, 3 and 5 years were 23.4%, 28.2%,28.2% and 46.2% respectively in UC patients and 12.9%, 20.1%, 24.6% and 46.7% respectively in CD patients. Among the 18 relapsing patients, 14 were retreated by AZA and 12 achieved successful remission. CRP, FC and Hb levels at AZA interruption and CRP and FC levels at 6 and 12 months after AZA discontinuation were not associated with risk of relapse. A multivariate analysis showed that the steroid-dependence status and the late or early introduction of AZA in UC and CD respectively were predictors of relapse. Conclusions: Half of the IBD patients who discontinue AZA therapy have a disease relapse after 5 years. However, 50% of the patients tolerate desintensification for a long period without relapsing. The steroid dependence status is an important factor that should be taken into account when deciding to discontinue AZA. It may help identify which patients should be closely monitored because they are prone to relapse. A prospective study should be performed to confirm this finding.
Su1007 Development and Validation of a Questionnaire to Assess Irritable Bowel Syndrome, Gastrointestinal Symptoms and Nutritional Habits Among Endurance Athletes Lauren Killian, Soo-Yeun Lee Background: Gastrointestinal (GI) symptoms are reported in a large proportion of endurance athletes, with many similarities in symptom type and distribution to irritable bowel symptom (IBS) patients. While many studies report athlete GI symptoms, to the best of our knowledge, no studies have examined actual IBS diagnoses or fit to IBS diagnostic criteria among this group. Objective: The objective of this study was to develop and validate a questionnaire to assess actual IBS diagnoses by a medical professional or fit to either Manning or Rome III diagnostic criteria for IBS among endurance athletes. Methods: A 92 item Endurance Athlete Questionnaire was developed which incorporated portions of an existing athlete GI symptom questionnaire, the Manning criteria and the Rome III Diagnostic Questionnaire for Adult Functional GI Disorders focusing on functional bowel disorders. Other important factors included gastrointestinal symptoms, nutritional habits and symptom mitigation strategies. The questionnaire was targeted at endurance athletes who will have completed at least one of the following events within 2015: marathon, ultra-marathon, half-distance triathlon, or full-distance triathlon. Content validity was established by expert reviewers and face validity was evaluated by endurance athletes who had completed at least one of the qualifying events within the last three years. Test-retest reliability was assessed with a group of target athletes recruited through local running and triathlon clubs as well as social media. Results: Six expert reviewers evaluated content validity, of which three were gastroenterologists and three were Registered Dietitians specializing in working with athletes. Reviewers suggested slight modifications in wording, but no major problems were identified. Face validity was evaluated by nine endurance athletes. All athletes understood the items and a few minor modifications in wording were suggested. Athletes also recommended the addition of a question on tobacco and alcohol use. The questionnaire was administered to target population athletes (n=45) on two occasions, separated by 1-2 weeks. Analysis was performed on the applicable item scores of 42 subjects (3 subjects reported a major GI issue within the last week on only one questionnaire). The Pearson correlation coefficient for the test-retest was significant at 0.810 (p<0.001). Conclusion: The Endurance Athlete Questionnaire had good content and face validity and proved to be a reliable measure of GI symptoms and IBS diagnostic criteria among endurance athletes. This questionnaire is needed to evaluate diagnosed and undiagnosed IBS in endurance athletes as well as symptomatic athletes who do not fit the diagnostic criteria. This will aid in future research examining nutritional modifications that may help mitigate athlete GI symptoms.
Su1008 Health-Related Quality of Life Improves During One Year of Postoperative Prophylactic Drug Therapy After Ileocecal Intestinal Resection in Crohn's Disease Patients: Results of the APPRECIA Randomized Trial Carlos Taxonera, Antonio Lopez-Sanroman, Isabel Vera, Pilar Nos Background: Health-related quality of life (HRQoL) is impaired in patients with Crohn‘s disease (CD). HRQoL improvement after intestinal resection for complicated CD is uncertain, due to the high rate of postoperative disease recurrence. The aim of our study was to assess HRQoL changes in CD patients undergoing ileocecal intestinal resection, who received postoperative drug therapy with either adalimumab or azathioprine. Methods: In the prospective multicenter APPRECIA trial, CD patients undergoing ileocecal intestinal resection were randomized 1/1 to receive postoperative therapy with azathioprine or adalimumab. Primary endpoint was endoscopic recurrence (Rutgeerts' 2b, 3, 4) at week 52. Changes in HRQoL were a secondary objective of the study. HRQoL was measured at baseline (2 weeks after surgery) and at weeks 24 and 52, using the generic EuroQoL-5 dimensions questionnaire (EQ-5D) and the disease-specific Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Baseline-endpoint changes in SIBDQ and EQ-5D were assessed using two-samples t-test for SIBDQ score and Wilcoxon test for EQ-5D score. Results: In the APPRECIA trial, study drugs were administered to 86 patients. A total of 73 CD patients (44 adalimumab group, 29 azathioprine group) completed all questionnaires and were evaluable. HRQoL was poor at baseline, but improved significantly at weeks 24 and 52 in both treatment groups (p<0.01 for SIBDQ and EQ-5D at weeks 24 and 52). At both weeks 24 and 52, we found no significant differences between treatments, either in total scores or in individual dimensions of the EQ-5D and SIBDQ scores. Mean improvement in HRQoL scores from baseline to week 52 were significantly greater in patients without endoscopic recurrence (p=0.01 for SIBDQ and p=0.04 for EQ-5D). Conclusion: In CD patients postoperative prophylactic drug therapy (with azathioprine or adalimumab) after ileocecal intestinal resection, resulted in a significant and sustained improvement in HRQoL. There were no significant differences in HRQoL between treatment groups. Patients without endoscopic recurrence had greater
AGA Abstracts
S-442
AGA Abstracts
Risk of Relapse After Azathioprine (AZA) Discontinuation in Inflammatory Bowel Disease (IBD) Patients in Maintained Remission Marisa Iborra, Julia Herreras, Marta M. Bosca-Watts, Xavier Cortés, Belén Navarro, María Teresa Blázquez Martínez, Galo A. Trejo, Belen Beltran, Pilar Nos The benefits of immunosuppressive therapies on the prevention of relapses have been demonstrated in IBD patients. However, the moment at which AZA could be stopped, after being in a long-term remission, remains controversial. The aim of this study was to identify potential predictors of relapse after AZA discontinuation in IBD patients who presented long-term and sustained remission before AZA removal. Methods: A multicenter study including 55 IBD patients, 33 Crohn`s disease (CD) and 22 ulcerative colitis (UC) patients, who had stopped AZA treatment while in prolonged remission. The following variables were collected: demographic data, the Montreal classification, indication of AZA treatment, steroiddependence and steroid-refractory status, AZA treatment duration and time until relapse. The presence of clinical and/or endoscopic remission and biologic values (C- reactive protein (CRP), fecal calprotectin (FC) and hemoglobin (Hb) levels) at AZA interruption were collected. FC and CRP measurements were assessed at 6 and 12 months in order to monitor whether the remission was maintained. Results: The main characteristics of the population are showed in table 1. Patients had been in remission for a mean time of 3-4 years. No UC patients had received biological therapy before taking AZA, whereas 3 (9.1%) CD patients had been previously treated with anti-TNF. Endoscopic remission was evaluated in 13 UC (59%) and 18 CD (55%) patients. After AZA discontinuation, 19 UC (86%) and 16 CD (49%) patients were treated with high doses of salicylates. Time-to-relapse rate after AZA withdrawal was estimated using the Kaplan-Meier method (figure 1). The median followup time after AZA interruption was 36.7 months; overall relapse was 32% (7 patients) in UC and 33% (11patients) in CD. The cumulative relapse rates at 1, 2, 3 and 5 years were 23.4%, 28.2%,28.2% and 46.2% respectively in UC patients and 12.9%, 20.1%, 24.6% and 46.7% respectively in CD patients. Among the 18 relapsing patients, 14 were retreated by AZA and 12 achieved successful remission. CRP, FC and Hb levels at AZA interruption and CRP and FC levels at 6 and 12 months after AZA discontinuation were not associated with risk of relapse. A multivariate analysis showed that the steroid-dependence status and the late or early introduction of AZA in UC and CD respectively were predictors of relapse. Conclusions: Half of the IBD patients who discontinue AZA therapy have a disease relapse after 5 years. However, 50% of the patients tolerate desintensification for a long period without relapsing. The steroid dependence status is an important factor that should be taken into account when deciding to discontinue AZA. It may help identify which patients should be closely monitored because they are prone to relapse. A prospective study should be performed to confirm this finding.
Su1007 Development and Validation of a Questionnaire to Assess Irritable Bowel Syndrome, Gastrointestinal Symptoms and Nutritional Habits Among Endurance Athletes Lauren Killian, Soo-Yeun Lee Background: Gastrointestinal (GI) symptoms are reported in a large proportion of endurance athletes, with many similarities in symptom type and distribution to irritable bowel symptom (IBS) patients. While many studies report athlete GI symptoms, to the best of our knowledge, no studies have examined actual IBS diagnoses or fit to IBS diagnostic criteria among this group. Objective: The objective of this study was to develop and validate a questionnaire to assess actual IBS diagnoses by a medical professional or fit to either Manning or Rome III diagnostic criteria for IBS among endurance athletes. Methods: A 92 item Endurance Athlete Questionnaire was developed which incorporated portions of an existing athlete GI symptom questionnaire, the Manning criteria and the Rome III Diagnostic Questionnaire for Adult Functional GI Disorders focusing on functional bowel disorders. Other important factors included gastrointestinal symptoms, nutritional habits and symptom mitigation strategies. The questionnaire was targeted at endurance athletes who will have completed at least one of the following events within 2015: marathon, ultra-marathon, half-distance triathlon, or full-distance triathlon. Content validity was established by expert reviewers and face validity was evaluated by endurance athletes who had completed at least one of the qualifying events within the last three years. Test-retest reliability was assessed with a group of target athletes recruited through local running and triathlon clubs as well as social media. Results: Six expert reviewers evaluated content validity, of which three were gastroenterologists and three were Registered Dietitians specializing in working with athletes. Reviewers suggested slight modifications in wording, but no major problems were identified. Face validity was evaluated by nine endurance athletes. All athletes understood the items and a few minor modifications in wording were suggested. Athletes also recommended the addition of a question on tobacco and alcohol use. The questionnaire was administered to target population athletes (n=45) on two occasions, separated by 1-2 weeks. Analysis was performed on the applicable item scores of 42 subjects (3 subjects reported a major GI issue within the last week on only one questionnaire). The Pearson correlation coefficient for the test-retest was significant at 0.810 (p<0.001). Conclusion: The Endurance Athlete Questionnaire had good content and face validity and proved to be a reliable measure of GI symptoms and IBS diagnostic criteria among endurance athletes. This questionnaire is needed to evaluate diagnosed and undiagnosed IBS in endurance athletes as well as symptomatic athletes who do not fit the diagnostic criteria. This will aid in future research examining nutritional modifications that may help mitigate athlete GI symptoms.
Su1008 Health-Related Quality of Life Improves During One Year of Postoperative Prophylactic Drug Therapy After Ileocecal Intestinal Resection in Crohn's Disease Patients: Results of the APPRECIA Randomized Trial Carlos Taxonera, Antonio Lopez-Sanroman, Isabel Vera, Pilar Nos Background: Health-related quality of life (HRQoL) is impaired in patients with Crohn‘s disease (CD). HRQoL improvement after intestinal resection for complicated CD is uncertain, due to the high rate of postoperative disease recurrence. The aim of our study was to assess HRQoL changes in CD patients undergoing ileocecal intestinal resection, who received postoperative drug therapy with either adalimumab or azathioprine. Methods: In the prospective multicenter APPRECIA trial, CD patients undergoing ileocecal intestinal resection were randomized 1/1 to receive postoperative therapy with azathioprine or adalimumab. Primary endpoint was endoscopic recurrence (Rutgeerts' 2b, 3, 4) at week 52. Changes in HRQoL were a secondary objective of the study. HRQoL was measured at baseline (2 weeks after surgery) and at weeks 24 and 52, using the generic EuroQoL-5 dimensions questionnaire (EQ-5D) and the disease-specific Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Baseline-endpoint changes in SIBDQ and EQ-5D were assessed using two-samples t-test for SIBDQ score and Wilcoxon test for EQ-5D score. Results: In the APPRECIA trial, study drugs were administered to 86 patients. A total of 73 CD patients (44 adalimumab group, 29 azathioprine group) completed all questionnaires and were evaluable. HRQoL was poor at baseline, but improved significantly at weeks 24 and 52 in both treatment groups (p<0.01 for SIBDQ and EQ-5D at weeks 24 and 52). At both weeks 24 and 52, we found no significant differences between treatments, either in total scores or in individual dimensions of the EQ-5D and SIBDQ scores. Mean improvement in HRQoL scores from baseline to week 52 were significantly greater in patients without endoscopic recurrence (p=0.01 for SIBDQ and p=0.04 for EQ-5D). Conclusion: In CD patients postoperative prophylactic drug therapy (with azathioprine or adalimumab) after ileocecal intestinal resection, resulted in a significant and sustained improvement in HRQoL. There were no significant differences in HRQoL between treatment groups. Patients without endoscopic recurrence had greater
AGA Abstracts
S-442