- Email: [email protected]
Biosimilars for Inflammatory Bowel Disease
increases in the HRQoL scores. Both EQ-5D and SIBDQ questionnaires performed similarly in the detection of changes in HRQoL.
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INTRODUCTION: Behavioral health interventions (BHI) have been shown to improve symptoms and quality of life (QOL) in patients with gastrointestinal disorders, including irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD). However, traditional BHI may not be equally effective between different gastrointestinal disorders. The aim of this study was to better understand differences in health-related QOL domains between IBS and IBD. METHODS: Data were extracted from a clinical patient intake form and questionnaires between 2014-15 at a single center GI behavioral health clinic. The clinical intake included a checklist of psychosocial concerns, measure of psychological distress, and a measure of bowel specific QOL. The Irritable Bowel Syndrome Quality of Life (IBS-QOL), a standardized tool for assessing multiple domains influenced by GI conditions, was completed at baseline and termination. Individual QOL domain components and total QOL composite scores were compared between IBS and IBD patients using a chi-squared and Student's t-test, respectively. A multiple linear regression of baseline patient characteristics was used to model QOL score in efforts to predict those with poor QOL. RESULTS: The cohort of patients completing baseline surveys included 136 subjects, 106 with IBS and 30 with IBD; 76.4% were female with no difference in gender proportion by diagnosis ( p=0.865). Among individual QOL elements, IBD patients exhibited more anger over their diagnosis (median 3.5 vs. 3.0, p= 0.022), but less impact on sexual elements (median 4.0 vs. 2.5, p=0.043) compared to IBS patients. Mean QOL total scores did not differ between IBD and IBS patients (112.3 vs. 109.8, p=0.689). Multivariate linear regression of baseline psychosocial factors identified several factors predicting the total QOL score, including loss of independence, difficulties communicating about illness, and GI symptom severity as significant elements, with a model adjusted r2=0.5295, p<0.0001 (Figure 1). As part of a preliminary interim analysis examining 31 patients (n=8 IBD) who completed termination surveys, mean QOL improvement was 26.1 (SD 25.4) with 71.0% (22/31) achieving a QOL improvement of at least 20 points, indicating clinically meaningful response to BHI. While awaiting collection of all termination surveys, no difference in mean QOL improvement or achievement of ‡20pt QOL improvement was observed between IBD and IBS (p=0.745 and 0.430, respectively). CONCLUSIONS: QOL impairment is similar between IBD and IBS patients undergoing GI-focused BHI. Disability, reduction of independence from disease, and challenges in communicating complexities of illness have impact on QOL and may warrant more focus in BHI for both IBS and IBD. While the study is ongoing, similar degrees of threshold QOL improvement suggests that BHI techniques are effective for both IBS and IBD patients.
Influence of Sleep Disorder on Somatic Symptoms, Mental Health and Quality of Life of Patients With Chronic Constipation Ya Jiang BACKGROUND: Sleep disorder is one of the most common mental symptoms in chronic constipation (CC). CC patients with sleep disorder have more complaints about the somatic/ psychiatric symptoms and quality of life. AIM: To investigate the influence of sleep disorder on the somatic symptoms, mental health and quality of life of patients with chronic constipation. METHODS: One hundred and twenty-six adult outpatients with chronic constipation who were treated at the Department of Gastroenterology of the First Affiliated Hospital of Nanjing Medical University were included in the study. A questionnaire survey was conducted using a demographic information questionnaire, a constipation symptom questionnaire, the Pittsburgh Sleep Quality Index (PSQI) questionnaire, Constipation Scoring System (CSS) questionnaire, the Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire, the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire, General Anxiety Disorder-7(GAD-7) questionnaire, the Patient Health Questionnaire-9 (PHQ-9) for depression and SF-36 questionnaire. According to PSQI scores, patients with chronic constipation were divided into sleep disorder group and normal sleep group. The influence of sleep disorder on somatic symptoms of chronic constipation, mental state, constipationrelated quality of life and health-related quality of life were analyzed. RESULTS: Fifty-nine CC patients with sleep disorders and sixty-seven CC patients with normal sleep were enrolled in our study. Significant differences were observed in incidence rate of sensation of incomplete defection and blockage in two groups (all P< 0.05). The sleep disorder and normal sleep groups differed significantly in their CSS scores and rating of "rectal item" in PAC-SYM ( P= 0.041), but no significant difference was seen in other items of somatic symptoms. Scores of GAD-7, PHQ-9 and "worry/anxiety" item in PAC-QOL were all significantly higher in the sleep disorder group than in the normal sleep group (all P< 0.05). And seven-eighths of dimensions in SF-36 were significantly lower in CC patients with poor sleep. Furthermore, rating of GAD-7 and PHQ-9 were correlated positively with scores of somatic symptoms in CC patients (all P<0.01). PAC-QOL and SF-36 scores were all related to severity of constipation and anxiety or depression (all P< 0.05). CONCLUSION: Sleep disorder can impair the somatic health, mental health and quality of life of CC patients. The mutual effect exists between anxiety/depression and constipation and they work together to lower CC patients' quality of life. Sleep disorder plays an important role in this link.
Su1010 Comparison of Efficacy and Safety of Hyoscine Butylbromide Versus Anisodamine for Acute Gastric or Intestinal Spasm-Like Pain: Results From a Randomized, Double-Blind, Parallel-Group, Multi-Center Phase III Trial in Chinese Patients Chunping Zhu, Fei Jiang, Xiao-hua Hou, Rongquan Wang, Xiaozhong Guo, Hong Xu, Yiqi Du, Ursula Koehler, Hongbo Zhu, Zhaoshen Li Background: Acute gastric or intestinal spasm-like pain occurs in 30% of the adult population. Hyoscine butylbromide (HBB), an anticholinergic agent, relieves the pain of stomach and bowel cramps by inhibiting smooth muscle contractility, resulting in relief from spasms in the digestive system. Ten placebo-controlled studies have demonstrated a benefit with HBB for the treatment of abdominal pain or discomfort associated with cramping. Currently, the most common treatment option for acute gastric or intestinal spasm-like pain in China is anisodamine (654-II), an anticholinergic and a1-adrenergic receptor antagonist. Aims: The present trial compared the efficacy and safety of parenteral HBB versus anisodamine, for acute gastric or intestinal spasm-like pain, in Chinese patients. Method: Randomized, active-controlled, double-blind, parallel-group, multi-center trial. Patients were randomly assigned to HBB 20 mg or anisodamine 10 mg in a 1:1 ratio; patients were administered a single dose of either HBB or anisodamine, and if needed, a second dose was used. The primary endpoint was the pain intensity difference (PID) from pre-dose baseline at 20 min after the first injection. Results: A total of 299 Chinese patients were entered into this trial; 295 were treated: 153 and 142 in the HBB and anisodamine groups, respectively. Baseline demographics were balanced between the two treatment groups. For the primary endpoint, the PID from pre-dose baseline at 20 min after the first injection, the adjusted mean change (SE) from baseline was -4.09 (0.17; 95% CI -4.41, -3.76) for the HBB group and -3.66 (0.18; 95% CI -4.02, -3.31) for the anisodamine group. The adjusted mean difference between the two treatment groups was -0.42 (SE 0.23; 95% CI -0.88, 0.04), indicating that HBB was non-inferior to anisodamine. In the subsequent superiority test of HBB over anisodamine, the treatment effect was numerically in favor of HBB (p=0.0743). The percentage of patients with at least one adverse event (AE) was lower in the HBB group (13.1% [20/ 153]) than in the anisodamine group (17.6% [25/142]). The most frequently reported AEs (‡2% in either treatment group) were thirst (7.8%) and dry mouth (2.6%) in the HBB group, and thirst (7.0%), dry mouth (3.5%), and nodal arrhythmia (2.1%) in the anisodamine group. Conclusions: HBB 20 mg was non-inferior to anisodamine 10 mg in pain relief of Chinese patients with acute gastric or intestinal spasm-like pain. The treatment effect was slightly in favor of HBB. Both drugs were safe and well tolerated, and the patients in the HBB 20 mg group experienced fewer adverse events than those on in the anisodamine 10 mg group. These results suggest a favorable benefit-risk ratio of HBB in treating Chinese patients with acute gastric or intestinal spasm-like pain.
Figure 1. Factors predictive of baseline QOL score in IBS and IBD patients. Multivariate linear regression of factors on intake GI questionnaire demonstrated several factors that significantly contributed to models of predicting baseline QOL score. Diagnosis of IBS vs. IBD did not significantly impact quality of life.
Su1012 Canadian Patient and Caregiver Perspectives on Subsequent Entry Biologics/ Biosimilars for Inflammatory Bowel Disease Gail Attara, Brian Bressler, Robert Bailey, John.K. Marshall, Remo Panaccione, Guy Aumais Background Biologic medications have revolutionized the treatment of inflammatory bowel disease (IBD). Subsequent Entry Biologics (SEBs) or are not identical in structure, therapeutic equivalence, or approved indications, but are biosimilar to an original biologic medication. Given the recent presence of SEBs in Canada, there might be implications for IBD patients and/or caregivers. Methods To understand the perspectives of IBD patients and caregivers regarding SEBs and how Canadian drug programs will manage these products, during early 2015, the Gastrointestinal Society, a patient group, hosted a survey on its two websites: www.badgut.org and www.mauxdeventre.org. The physicians included in this project shared the links with their patients. To qualify, survey participants confirmed they either had IBD or were a caregiver of a person with IBD. Questions included demographic information, disease characteristics, as well as their understanding and opinions regarding SEBs, including the possibility of switching from an innovator biologic to a biosimilar. Results 423 respondents: 317 English, 106 French. 68% had Crohn's disease, 30% ulcerative colitis, 2% indeterminate IBD. 77% had at least a basic understanding of biologics and were currently prescribed an originator biologic - Remicade® (infliximab), Humira (adalimumab), or Simponi® (golimumab). 76% had heard about SEBs. Majority of patients selected cost then manufacturing process, as the top ways SEBs might differ from originator biologics. 52% believed that having the same international non-proprietary name (INN) implied that patients could safely switch between the products during a course of treatment and expect the same effectiveness and safety, even though Health Canada states they are not interchangeable. 95% of those surveyed said that it is important their physician, together with them, have sole authority
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AGA Abstracts
AGA Abstracts
Comparison of Quality of Life and Treatment Response in IBS and IBD Patients Undergoing GI-Focused Behavioral Health Interventions Megan E. Riehl, William D. Chey, Ryan W. Stidham
AGA Abstracts
to decide the most suitable biologic medication to treat their disease. The most important considerations in choosing SEB treatment for patients were safety, efficacy, and that both the originator and biosimilar have identical review and approval processes. 96% of respondents were concerned about limited medication choice during induction and/or maintenance therapy. Conclusions IBD patients who responded to our survey were quite familiar with SEBs, although they expressed high concerns around safety, efficacy, and regulatory process. The patient choice directive is very strong and shows the need for open dialogue among patients, physicians, manufacturers, and regulatory bodies for the safe introduction of SEBs into the marketplace.
Su1015 The Validity of a New Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) for Use in the Clinical Setting Hannes Holz, Natasha A. Koloski, Michael P. Jones, Marguerite DeBarros, Daniel Burger, Neal Martin, Johann Hammer, Moritz T. von Wulffen, Nicholas J. Talley, Gerald Holtmann Background: The lack of an instrument for the assessment of the severity and impact of gastrointestinal symptoms in the clinical setting prompted the development of the Structured Assessment of Gastrointestinal Symptoms (SAGIS) Instrument. We aimed to determine the reliability and validity of the SAGIS in the clinical setting. Methods: 45 patients with a variety of gastrointestinal problems referred for assessment and treatment at a large tertiary hospital were given the SAGIS prior to their consultation. The SAGIS includes questions on the severity of 23 upper and lower gastrointestinal symptoms over the past week. Responses are given on a 5 point likert scale that includes no problem, mild, moderate, severe and very severe problem. Patients also completed the validated Rome III questions for irritable bowel syndrome (IBS) and functional dyspepsia (FD), IBS Symptom Severity Scale (IBS-SSS) and the Hospital Anxiety and Depression Scale (HADS). A group of 194 patients were also given the SAGIS to complete again 1 week later to assess the test re test reliability of the measure. Results: Convergent validity was established by correlations between the individual scales of five SAGIS domains ( 1.)Epigastric Pain, 2.) IBS-D, 3.) Acid regurgitation, 4.) Nausea/Vomiting, 5.) Constipation) and the individual scales of the IBS-SSS and the HADS. Four of five SAGIS domains correlate well with the IBS-SSS (Pearson Correlation: 1.) 0.683, 2.) 0.500, 3.) 0.551, 4.) 0.474, 5.) 0.153) but none with either anxiety or depression from the HADS. Discriminant validity was assessed by correlations between the five SAGIS domains and the Rome III criteria for individuals who have IBS and FD versus do not meet criteria for these conditions. The results are supportive both in terms of where there is clear discrimination but also in terms of where there is not. For example, the IBS-D domain does clearly differentiate IBS from non-IBS but the epigastric pain domain does not, as one would expect (Wilcoxon-Mann-Whitney-Test: IBS-D 0.001, epigastric pain 0.07). The reverse is true when discriminating FD from non-FD, again as would be expected (Wilcoxon-Mann-Whitney-Test: IBS-D 0.5, epigastric pain 0.02).When n=194 patients were given the SAGIS and then retested 1 week later their paired scores for the five SAGIS domains did not change significantly with a maximum change of 12% from baseline and were well correlated ( 1.) 0.716, 2.) 0.615, 3.) 0.548, 4.) 0.634 5.) 0.660). The results indicate ordinal agreement between occasions. All Cohen's d values are well inside the small range (<0.4) (d values: 1.) 0.18, 2.) 0.11, 3.) 0.00, 4.) 0.04, 5.) 0.10). Overall the data support excellent test-retest reliability. Conclusions: The SAGIS is a reliable and valid measure that is suitable to assess severity and impact of GI symptoms in the clinical setting.
Su1013 Case-Control Analysis of Risk Factors for Poor Bowel Preparations in Outpatient Cohorts Marguerite DeBarros, Luke F. Hourigan, Natasha A. Koloski, Graeme Rich, Amanda Whaley, Louise Young, Nicholas J. Talley, Belinda Johnson, Gerald Holtmann Background: The quality of bowel preparation is a key determinant for the overall quality of colonoscopies since the polyp detection rate is adversely affected in patients with poor bowel preparation. In addition, poor bowel preparation can be costly since this may require repeat procedures. So far, quality improvement studies have aimed to improve the bowel prep regimen by modifying the regimen (e.g. split-prep versus single dose), the ingredients (e.g. PEG vs Sodium Phosphate Solution) or to identify risk factors such as underlying metabolic disorders. However, it may well be that other factors such as compliance or language barriers are critical for the quality of the bowel preparation. Methods: As part of our routine quality improvement program, we conducted a case-control study to identify risk factors associated with poor bowel preparation. In a standardised fashion, the quality of bowel preparations was assessed in all patients and those with poor bowel preparation identified. Prior to the procedure, all patients underwent standardised bowel preparation education and received split-preparation product free of charge. All patients with poor bowel preparation were matched by two patients with good bowel preparation from the same procedure list to minimise effects of inter-rater variability. For all patients and controls, comorbidities and socio-demographic background (as determined by postcode of primary residency) were assessed. Univariate (Chi-square) and logistic regression were used to quantitate. Results: Out of 434 consecutive colonoscopies during a two month period 22 were found to have a poor bowel preparation. Univariate analysis revealed that residence in a region with lower socio-economic background was a risk factor for poor bowel prep (RR 3.4, 95% CI 1.18-10.0). Age, sex, employment status, comorbidities or the need to use an interpreter were not associated with the quality of bowel prep. Conclusion: Our data demonstrates a link between socio-demographic factors and the quality of bowel preparations. It might be speculated that this is mediated via apprehension and compliance with the instructions for the bowel preparation. Our findings suggest targeted measures to improve the quality of bowel preparation in these groups.
Su1016 Fecal Immunochemical Test Versus Fecal Calprotectin for the Predictive Ability of the Prognosis of Ulcerative Colitis Asuka Nakarai, Sakiko Hiraoka, Jun Kato, Toshihiro Inokuchi, Shiho Takashima, Daisuke Takei, Yuusaku Sugihara, Masahiro Takahara, Keita Harada, Hiroyuki Okada
Su1014 Evidence of Content Validity and Psychometric Properties of Sf-36 for Measuring Health-Related Quality of Life of Patients With Crohn's Disease Aaron Yarlas, Michelle White, Mike Ingham, Chenglong Han
Abstract body Background: We previously reported that ulcerative colitis (UC) patients in clinical remission with Mayo endoscopic subscore (MES) 0 showed lower risk of relapse relative to those with MES 1-3, and a quantitative fecal immunochemical test (FIT) could be useful for evaluating relapse risk (DDW 2015). On the other hand, fecal calprotectin (Fcal) has also been reported as an important predictive factor of UC prognosis. The aim of this study was to compare the predictive ability of these two fecal markers for the clinical prognosis in UC. Methods: We prospectively observed the clinical prognosis of UC patients in clinical remission with MES 0, based on FIT and Fcal results. Results: In total, 87 UC patients in clinical remission with MES 0 were eligible to this study (46 male; median age 47 years). Their one-year relapse rate was 16%. We divided 87 patients into two groups according to the each median of FIT and Fcal results (the media of FIT; 50 ng/ml, Fcal; 65 µg/g), and compared the clinical prognosis of both groups. While the positive FIT result group (FIT > 50 ng/ml) showed statistically significantly higher risk of relapse relative to the negative FIT result group (FIT % 50 ng/ml) (Hazard ratio (HR) = 3.36; 95% confidence interval (CI), 1.98-8.60), there was no difference of clinical prognosis between the positive (Fcal > 65µg/g) and negative (Fcal % 65µg/g) Fcal result group (HR of relapse = 1.10; 95% CI, 0.47-2.65). Conclusions: FIT could predict the clinical prognosis of UC patients in clinical remission with MES 0. In contrast, Fcal could not predict in this study.
Objective: A literature review and cognitive debriefing interviews were conducted to assess the adequacy of evidence for the SF-36® Health Survey (SF-36) as a valid and reliable instrument for measuring Health Related quality of life (HRQOL) in patients with Crohn's disease (CD) in clinical trials. Methods: A literature search of several medical databases (eg Medline, Ovid) used search terms for variations of "SF-36" and "Crohn's disease" in the title or abstract of English language publications within the past 20 years. Among 327 identified abstracts, 76 full-text articles were reviewed, of which 34 articles were selected for data extraction based on appropriateness of content. Evidence of content validity and psychometric properties was evaluated based on the criteria specified in the FDA Guidance for Industry, "Patient-Reported Outcome Measures: Use in Medicinal Product Development to Support Labeling Claims." In addition, a cognitive debriefing study of the SF-36 was conducted via qualitative interviews with 16 patients with moderate-to-severe CD. Results: Concept elicitation studies supported content validity, where concepts reported by patients on the impact of CD on their daily functioning and well-being were well aligned with concepts measured by the SF-36 and were not redundant with disease-specific measures in HRQOL in CD. Cognitive debriefing interviews confirmed the relevance and comprehensiveness of all concepts covered by SF-36, as well as appropriateness of the instructions, response scales, and recall period. Evidence showed that SF-36 scores for patients with CD were consistently lower than normative scores from the general population and similar to patients with other chronic conditions such as diabetes and asthma. The literature supported the ability of SF36 scales and summary scores to detect clinically meaningful change in HRQOL in patients with CD receiving effective treatment. Convergent and discriminant validity were demonstrated by the evidence that SF-36 scores highly correlated with scores of other HRQOL measures in patients with CD and clinically meaningful differences were found on all SF36 scales when comparing patients with CD across levels of disease activity. Reported findings from samples of patients with CD included evidence for good internal consistency reliability (Cronbach's alphas ranging from 0.72 to 0.90) and good test-retest reliability (intraclass correlation coefficients ranging from 0.72 to 0.89) for all eight SF-36 scales. Conclusion: The comprehensive literature review and cognitive debriefing study demonstrated evidence for content validity and strong psychometric properties of SF-36 when used in patients with CD across different disease activities.
AGA Abstracts
Su1017 Comparative Short and Long-Term Efficacy of Infliximab and Adalimumab in Patients With Ulcerative Colitis Refractory to Corticosteroids: A Retrospective Study Naoki Yoshimura, Minako Sako, Masakazu Takazoe Background: Currently, anti-tumour necrosis factor (anti-TNF) biologics, infliximab (IFX) and adalimumab (ADA), are administered to induce and maintain clinical remission in patients with steroid-refractory ulcerative colitis (UC), while the subsequent loss of response to biologics during maintenance therapy remains a challenging clinical issue. This study was to evaluate the short and long-term efficacy of IFX and ADA in patients with moderately to severely active UC, anti-TNF naive, as well as those with prior exposure to an anti-TNF. Methods: In a single-centre retrospective setting, 111 consecutive patients with moderately to severely active UC refractory to corticosteroids were included. Seventy-six patients were treated with IFX; 64 naïve to an anti-TNF and 12 had switched from another anti-TNF, the remaining 35 patients were treated with ADA; 21 naïve, and 14 had switched. At week 8, clinical response rates were compared between the above 4 subgroups. Clinical response was defined as Rachmilewitz's clinical activity index (CAI) £4. The subsequent loss of response was defined as CAI ‡7. Patients with remission had received maintenance IFX (5mg/kg) every 8 weeks or ADA (40mg) at 2 weeks intervals. All patients were followed
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INTRODUCTION: Behavioral health interventions (BHI) have been shown to improve symptoms and quality of life (QOL) in patients with gastrointestinal disorders, including irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD). However, traditional BHI may not be equally effective between different gastrointestinal disorders. The aim of this study was to better understand differences in health-related QOL domains between IBS and IBD. METHODS: Data were extracted from a clinical patient intake form and questionnaires between 2014-15 at a single center GI behavioral health clinic. The clinical intake included a checklist of psychosocial concerns, measure of psychological distress, and a measure of bowel specific QOL. The Irritable Bowel Syndrome Quality of Life (IBS-QOL), a standardized tool for assessing multiple domains influenced by GI conditions, was completed at baseline and termination. Individual QOL domain components and total QOL composite scores were compared between IBS and IBD patients using a chi-squared and Student's t-test, respectively. A multiple linear regression of baseline patient characteristics was used to model QOL score in efforts to predict those with poor QOL. RESULTS: The cohort of patients completing baseline surveys included 136 subjects, 106 with IBS and 30 with IBD; 76.4% were female with no difference in gender proportion by diagnosis ( p=0.865). Among individual QOL elements, IBD patients exhibited more anger over their diagnosis (median 3.5 vs. 3.0, p= 0.022), but less impact on sexual elements (median 4.0 vs. 2.5, p=0.043) compared to IBS patients. Mean QOL total scores did not differ between IBD and IBS patients (112.3 vs. 109.8, p=0.689). Multivariate linear regression of baseline psychosocial factors identified several factors predicting the total QOL score, including loss of independence, difficulties communicating about illness, and GI symptom severity as significant elements, with a model adjusted r2=0.5295, p<0.0001 (Figure 1). As part of a preliminary interim analysis examining 31 patients (n=8 IBD) who completed termination surveys, mean QOL improvement was 26.1 (SD 25.4) with 71.0% (22/31) achieving a QOL improvement of at least 20 points, indicating clinically meaningful response to BHI. While awaiting collection of all termination surveys, no difference in mean QOL improvement or achievement of ‡20pt QOL improvement was observed between IBD and IBS (p=0.745 and 0.430, respectively). CONCLUSIONS: QOL impairment is similar between IBD and IBS patients undergoing GI-focused BHI. Disability, reduction of independence from disease, and challenges in communicating complexities of illness have impact on QOL and may warrant more focus in BHI for both IBS and IBD. While the study is ongoing, similar degrees of threshold QOL improvement suggests that BHI techniques are effective for both IBS and IBD patients.
Influence of Sleep Disorder on Somatic Symptoms, Mental Health and Quality of Life of Patients With Chronic Constipation Ya Jiang BACKGROUND: Sleep disorder is one of the most common mental symptoms in chronic constipation (CC). CC patients with sleep disorder have more complaints about the somatic/ psychiatric symptoms and quality of life. AIM: To investigate the influence of sleep disorder on the somatic symptoms, mental health and quality of life of patients with chronic constipation. METHODS: One hundred and twenty-six adult outpatients with chronic constipation who were treated at the Department of Gastroenterology of the First Affiliated Hospital of Nanjing Medical University were included in the study. A questionnaire survey was conducted using a demographic information questionnaire, a constipation symptom questionnaire, the Pittsburgh Sleep Quality Index (PSQI) questionnaire, Constipation Scoring System (CSS) questionnaire, the Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire, the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire, General Anxiety Disorder-7(GAD-7) questionnaire, the Patient Health Questionnaire-9 (PHQ-9) for depression and SF-36 questionnaire. According to PSQI scores, patients with chronic constipation were divided into sleep disorder group and normal sleep group. The influence of sleep disorder on somatic symptoms of chronic constipation, mental state, constipationrelated quality of life and health-related quality of life were analyzed. RESULTS: Fifty-nine CC patients with sleep disorders and sixty-seven CC patients with normal sleep were enrolled in our study. Significant differences were observed in incidence rate of sensation of incomplete defection and blockage in two groups (all P< 0.05). The sleep disorder and normal sleep groups differed significantly in their CSS scores and rating of "rectal item" in PAC-SYM ( P= 0.041), but no significant difference was seen in other items of somatic symptoms. Scores of GAD-7, PHQ-9 and "worry/anxiety" item in PAC-QOL were all significantly higher in the sleep disorder group than in the normal sleep group (all P< 0.05). And seven-eighths of dimensions in SF-36 were significantly lower in CC patients with poor sleep. Furthermore, rating of GAD-7 and PHQ-9 were correlated positively with scores of somatic symptoms in CC patients (all P<0.01). PAC-QOL and SF-36 scores were all related to severity of constipation and anxiety or depression (all P< 0.05). CONCLUSION: Sleep disorder can impair the somatic health, mental health and quality of life of CC patients. The mutual effect exists between anxiety/depression and constipation and they work together to lower CC patients' quality of life. Sleep disorder plays an important role in this link.
Su1010 Comparison of Efficacy and Safety of Hyoscine Butylbromide Versus Anisodamine for Acute Gastric or Intestinal Spasm-Like Pain: Results From a Randomized, Double-Blind, Parallel-Group, Multi-Center Phase III Trial in Chinese Patients Chunping Zhu, Fei Jiang, Xiao-hua Hou, Rongquan Wang, Xiaozhong Guo, Hong Xu, Yiqi Du, Ursula Koehler, Hongbo Zhu, Zhaoshen Li Background: Acute gastric or intestinal spasm-like pain occurs in 30% of the adult population. Hyoscine butylbromide (HBB), an anticholinergic agent, relieves the pain of stomach and bowel cramps by inhibiting smooth muscle contractility, resulting in relief from spasms in the digestive system. Ten placebo-controlled studies have demonstrated a benefit with HBB for the treatment of abdominal pain or discomfort associated with cramping. Currently, the most common treatment option for acute gastric or intestinal spasm-like pain in China is anisodamine (654-II), an anticholinergic and a1-adrenergic receptor antagonist. Aims: The present trial compared the efficacy and safety of parenteral HBB versus anisodamine, for acute gastric or intestinal spasm-like pain, in Chinese patients. Method: Randomized, active-controlled, double-blind, parallel-group, multi-center trial. Patients were randomly assigned to HBB 20 mg or anisodamine 10 mg in a 1:1 ratio; patients were administered a single dose of either HBB or anisodamine, and if needed, a second dose was used. The primary endpoint was the pain intensity difference (PID) from pre-dose baseline at 20 min after the first injection. Results: A total of 299 Chinese patients were entered into this trial; 295 were treated: 153 and 142 in the HBB and anisodamine groups, respectively. Baseline demographics were balanced between the two treatment groups. For the primary endpoint, the PID from pre-dose baseline at 20 min after the first injection, the adjusted mean change (SE) from baseline was -4.09 (0.17; 95% CI -4.41, -3.76) for the HBB group and -3.66 (0.18; 95% CI -4.02, -3.31) for the anisodamine group. The adjusted mean difference between the two treatment groups was -0.42 (SE 0.23; 95% CI -0.88, 0.04), indicating that HBB was non-inferior to anisodamine. In the subsequent superiority test of HBB over anisodamine, the treatment effect was numerically in favor of HBB (p=0.0743). The percentage of patients with at least one adverse event (AE) was lower in the HBB group (13.1% [20/ 153]) than in the anisodamine group (17.6% [25/142]). The most frequently reported AEs (‡2% in either treatment group) were thirst (7.8%) and dry mouth (2.6%) in the HBB group, and thirst (7.0%), dry mouth (3.5%), and nodal arrhythmia (2.1%) in the anisodamine group. Conclusions: HBB 20 mg was non-inferior to anisodamine 10 mg in pain relief of Chinese patients with acute gastric or intestinal spasm-like pain. The treatment effect was slightly in favor of HBB. Both drugs were safe and well tolerated, and the patients in the HBB 20 mg group experienced fewer adverse events than those on in the anisodamine 10 mg group. These results suggest a favorable benefit-risk ratio of HBB in treating Chinese patients with acute gastric or intestinal spasm-like pain.
Figure 1. Factors predictive of baseline QOL score in IBS and IBD patients. Multivariate linear regression of factors on intake GI questionnaire demonstrated several factors that significantly contributed to models of predicting baseline QOL score. Diagnosis of IBS vs. IBD did not significantly impact quality of life.
Su1012 Canadian Patient and Caregiver Perspectives on Subsequent Entry Biologics/ Biosimilars for Inflammatory Bowel Disease Gail Attara, Brian Bressler, Robert Bailey, John.K. Marshall, Remo Panaccione, Guy Aumais Background Biologic medications have revolutionized the treatment of inflammatory bowel disease (IBD). Subsequent Entry Biologics (SEBs) or are not identical in structure, therapeutic equivalence, or approved indications, but are biosimilar to an original biologic medication. Given the recent presence of SEBs in Canada, there might be implications for IBD patients and/or caregivers. Methods To understand the perspectives of IBD patients and caregivers regarding SEBs and how Canadian drug programs will manage these products, during early 2015, the Gastrointestinal Society, a patient group, hosted a survey on its two websites: www.badgut.org and www.mauxdeventre.org. The physicians included in this project shared the links with their patients. To qualify, survey participants confirmed they either had IBD or were a caregiver of a person with IBD. Questions included demographic information, disease characteristics, as well as their understanding and opinions regarding SEBs, including the possibility of switching from an innovator biologic to a biosimilar. Results 423 respondents: 317 English, 106 French. 68% had Crohn's disease, 30% ulcerative colitis, 2% indeterminate IBD. 77% had at least a basic understanding of biologics and were currently prescribed an originator biologic - Remicade® (infliximab), Humira (adalimumab), or Simponi® (golimumab). 76% had heard about SEBs. Majority of patients selected cost then manufacturing process, as the top ways SEBs might differ from originator biologics. 52% believed that having the same international non-proprietary name (INN) implied that patients could safely switch between the products during a course of treatment and expect the same effectiveness and safety, even though Health Canada states they are not interchangeable. 95% of those surveyed said that it is important their physician, together with them, have sole authority
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AGA Abstracts
AGA Abstracts
Comparison of Quality of Life and Treatment Response in IBS and IBD Patients Undergoing GI-Focused Behavioral Health Interventions Megan E. Riehl, William D. Chey, Ryan W. Stidham
AGA Abstracts
to decide the most suitable biologic medication to treat their disease. The most important considerations in choosing SEB treatment for patients were safety, efficacy, and that both the originator and biosimilar have identical review and approval processes. 96% of respondents were concerned about limited medication choice during induction and/or maintenance therapy. Conclusions IBD patients who responded to our survey were quite familiar with SEBs, although they expressed high concerns around safety, efficacy, and regulatory process. The patient choice directive is very strong and shows the need for open dialogue among patients, physicians, manufacturers, and regulatory bodies for the safe introduction of SEBs into the marketplace.
Su1015 The Validity of a New Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) for Use in the Clinical Setting Hannes Holz, Natasha A. Koloski, Michael P. Jones, Marguerite DeBarros, Daniel Burger, Neal Martin, Johann Hammer, Moritz T. von Wulffen, Nicholas J. Talley, Gerald Holtmann Background: The lack of an instrument for the assessment of the severity and impact of gastrointestinal symptoms in the clinical setting prompted the development of the Structured Assessment of Gastrointestinal Symptoms (SAGIS) Instrument. We aimed to determine the reliability and validity of the SAGIS in the clinical setting. Methods: 45 patients with a variety of gastrointestinal problems referred for assessment and treatment at a large tertiary hospital were given the SAGIS prior to their consultation. The SAGIS includes questions on the severity of 23 upper and lower gastrointestinal symptoms over the past week. Responses are given on a 5 point likert scale that includes no problem, mild, moderate, severe and very severe problem. Patients also completed the validated Rome III questions for irritable bowel syndrome (IBS) and functional dyspepsia (FD), IBS Symptom Severity Scale (IBS-SSS) and the Hospital Anxiety and Depression Scale (HADS). A group of 194 patients were also given the SAGIS to complete again 1 week later to assess the test re test reliability of the measure. Results: Convergent validity was established by correlations between the individual scales of five SAGIS domains ( 1.)Epigastric Pain, 2.) IBS-D, 3.) Acid regurgitation, 4.) Nausea/Vomiting, 5.) Constipation) and the individual scales of the IBS-SSS and the HADS. Four of five SAGIS domains correlate well with the IBS-SSS (Pearson Correlation: 1.) 0.683, 2.) 0.500, 3.) 0.551, 4.) 0.474, 5.) 0.153) but none with either anxiety or depression from the HADS. Discriminant validity was assessed by correlations between the five SAGIS domains and the Rome III criteria for individuals who have IBS and FD versus do not meet criteria for these conditions. The results are supportive both in terms of where there is clear discrimination but also in terms of where there is not. For example, the IBS-D domain does clearly differentiate IBS from non-IBS but the epigastric pain domain does not, as one would expect (Wilcoxon-Mann-Whitney-Test: IBS-D 0.001, epigastric pain 0.07). The reverse is true when discriminating FD from non-FD, again as would be expected (Wilcoxon-Mann-Whitney-Test: IBS-D 0.5, epigastric pain 0.02).When n=194 patients were given the SAGIS and then retested 1 week later their paired scores for the five SAGIS domains did not change significantly with a maximum change of 12% from baseline and were well correlated ( 1.) 0.716, 2.) 0.615, 3.) 0.548, 4.) 0.634 5.) 0.660). The results indicate ordinal agreement between occasions. All Cohen's d values are well inside the small range (<0.4) (d values: 1.) 0.18, 2.) 0.11, 3.) 0.00, 4.) 0.04, 5.) 0.10). Overall the data support excellent test-retest reliability. Conclusions: The SAGIS is a reliable and valid measure that is suitable to assess severity and impact of GI symptoms in the clinical setting.
Su1013 Case-Control Analysis of Risk Factors for Poor Bowel Preparations in Outpatient Cohorts Marguerite DeBarros, Luke F. Hourigan, Natasha A. Koloski, Graeme Rich, Amanda Whaley, Louise Young, Nicholas J. Talley, Belinda Johnson, Gerald Holtmann Background: The quality of bowel preparation is a key determinant for the overall quality of colonoscopies since the polyp detection rate is adversely affected in patients with poor bowel preparation. In addition, poor bowel preparation can be costly since this may require repeat procedures. So far, quality improvement studies have aimed to improve the bowel prep regimen by modifying the regimen (e.g. split-prep versus single dose), the ingredients (e.g. PEG vs Sodium Phosphate Solution) or to identify risk factors such as underlying metabolic disorders. However, it may well be that other factors such as compliance or language barriers are critical for the quality of the bowel preparation. Methods: As part of our routine quality improvement program, we conducted a case-control study to identify risk factors associated with poor bowel preparation. In a standardised fashion, the quality of bowel preparations was assessed in all patients and those with poor bowel preparation identified. Prior to the procedure, all patients underwent standardised bowel preparation education and received split-preparation product free of charge. All patients with poor bowel preparation were matched by two patients with good bowel preparation from the same procedure list to minimise effects of inter-rater variability. For all patients and controls, comorbidities and socio-demographic background (as determined by postcode of primary residency) were assessed. Univariate (Chi-square) and logistic regression were used to quantitate. Results: Out of 434 consecutive colonoscopies during a two month period 22 were found to have a poor bowel preparation. Univariate analysis revealed that residence in a region with lower socio-economic background was a risk factor for poor bowel prep (RR 3.4, 95% CI 1.18-10.0). Age, sex, employment status, comorbidities or the need to use an interpreter were not associated with the quality of bowel prep. Conclusion: Our data demonstrates a link between socio-demographic factors and the quality of bowel preparations. It might be speculated that this is mediated via apprehension and compliance with the instructions for the bowel preparation. Our findings suggest targeted measures to improve the quality of bowel preparation in these groups.
Su1016 Fecal Immunochemical Test Versus Fecal Calprotectin for the Predictive Ability of the Prognosis of Ulcerative Colitis Asuka Nakarai, Sakiko Hiraoka, Jun Kato, Toshihiro Inokuchi, Shiho Takashima, Daisuke Takei, Yuusaku Sugihara, Masahiro Takahara, Keita Harada, Hiroyuki Okada
Su1014 Evidence of Content Validity and Psychometric Properties of Sf-36 for Measuring Health-Related Quality of Life of Patients With Crohn's Disease Aaron Yarlas, Michelle White, Mike Ingham, Chenglong Han
Abstract body Background: We previously reported that ulcerative colitis (UC) patients in clinical remission with Mayo endoscopic subscore (MES) 0 showed lower risk of relapse relative to those with MES 1-3, and a quantitative fecal immunochemical test (FIT) could be useful for evaluating relapse risk (DDW 2015). On the other hand, fecal calprotectin (Fcal) has also been reported as an important predictive factor of UC prognosis. The aim of this study was to compare the predictive ability of these two fecal markers for the clinical prognosis in UC. Methods: We prospectively observed the clinical prognosis of UC patients in clinical remission with MES 0, based on FIT and Fcal results. Results: In total, 87 UC patients in clinical remission with MES 0 were eligible to this study (46 male; median age 47 years). Their one-year relapse rate was 16%. We divided 87 patients into two groups according to the each median of FIT and Fcal results (the media of FIT; 50 ng/ml, Fcal; 65 µg/g), and compared the clinical prognosis of both groups. While the positive FIT result group (FIT > 50 ng/ml) showed statistically significantly higher risk of relapse relative to the negative FIT result group (FIT % 50 ng/ml) (Hazard ratio (HR) = 3.36; 95% confidence interval (CI), 1.98-8.60), there was no difference of clinical prognosis between the positive (Fcal > 65µg/g) and negative (Fcal % 65µg/g) Fcal result group (HR of relapse = 1.10; 95% CI, 0.47-2.65). Conclusions: FIT could predict the clinical prognosis of UC patients in clinical remission with MES 0. In contrast, Fcal could not predict in this study.
Objective: A literature review and cognitive debriefing interviews were conducted to assess the adequacy of evidence for the SF-36® Health Survey (SF-36) as a valid and reliable instrument for measuring Health Related quality of life (HRQOL) in patients with Crohn's disease (CD) in clinical trials. Methods: A literature search of several medical databases (eg Medline, Ovid) used search terms for variations of "SF-36" and "Crohn's disease" in the title or abstract of English language publications within the past 20 years. Among 327 identified abstracts, 76 full-text articles were reviewed, of which 34 articles were selected for data extraction based on appropriateness of content. Evidence of content validity and psychometric properties was evaluated based on the criteria specified in the FDA Guidance for Industry, "Patient-Reported Outcome Measures: Use in Medicinal Product Development to Support Labeling Claims." In addition, a cognitive debriefing study of the SF-36 was conducted via qualitative interviews with 16 patients with moderate-to-severe CD. Results: Concept elicitation studies supported content validity, where concepts reported by patients on the impact of CD on their daily functioning and well-being were well aligned with concepts measured by the SF-36 and were not redundant with disease-specific measures in HRQOL in CD. Cognitive debriefing interviews confirmed the relevance and comprehensiveness of all concepts covered by SF-36, as well as appropriateness of the instructions, response scales, and recall period. Evidence showed that SF-36 scores for patients with CD were consistently lower than normative scores from the general population and similar to patients with other chronic conditions such as diabetes and asthma. The literature supported the ability of SF36 scales and summary scores to detect clinically meaningful change in HRQOL in patients with CD receiving effective treatment. Convergent and discriminant validity were demonstrated by the evidence that SF-36 scores highly correlated with scores of other HRQOL measures in patients with CD and clinically meaningful differences were found on all SF36 scales when comparing patients with CD across levels of disease activity. Reported findings from samples of patients with CD included evidence for good internal consistency reliability (Cronbach's alphas ranging from 0.72 to 0.90) and good test-retest reliability (intraclass correlation coefficients ranging from 0.72 to 0.89) for all eight SF-36 scales. Conclusion: The comprehensive literature review and cognitive debriefing study demonstrated evidence for content validity and strong psychometric properties of SF-36 when used in patients with CD across different disease activities.
AGA Abstracts
Su1017 Comparative Short and Long-Term Efficacy of Infliximab and Adalimumab in Patients With Ulcerative Colitis Refractory to Corticosteroids: A Retrospective Study Naoki Yoshimura, Minako Sako, Masakazu Takazoe Background: Currently, anti-tumour necrosis factor (anti-TNF) biologics, infliximab (IFX) and adalimumab (ADA), are administered to induce and maintain clinical remission in patients with steroid-refractory ulcerative colitis (UC), while the subsequent loss of response to biologics during maintenance therapy remains a challenging clinical issue. This study was to evaluate the short and long-term efficacy of IFX and ADA in patients with moderately to severely active UC, anti-TNF naive, as well as those with prior exposure to an anti-TNF. Methods: In a single-centre retrospective setting, 111 consecutive patients with moderately to severely active UC refractory to corticosteroids were included. Seventy-six patients were treated with IFX; 64 naïve to an anti-TNF and 12 had switched from another anti-TNF, the remaining 35 patients were treated with ADA; 21 naïve, and 14 had switched. At week 8, clinical response rates were compared between the above 4 subgroups. Clinical response was defined as Rachmilewitz's clinical activity index (CAI) £4. The subsequent loss of response was defined as CAI ‡7. Patients with remission had received maintenance IFX (5mg/kg) every 8 weeks or ADA (40mg) at 2 weeks intervals. All patients were followed
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