Inflammatory Bowel Disease Questionnaire Scores Research Articles

PGI50 THE RELATIONSHIP BETWEEN DISEASE SEVERITY AND HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH ULCERATIVE COLITIS IN JAPAN

Patients with ulcerative colitis (UC) experience abdominal pain and bloody diarrhea during the active phase of their disease, and their health-related quality of life (HRQOL) is often disrupted. Understanding patient's HRQOL along with disease severity is an important guide to select their treatment options for both patients and physicians. The aim of this study is to assess the relationship between disease severity and HRQOL in patients with UC in Japan. We conducted a multi-center, cross-sectional study in patients with UC. Patients with a variety of disease severity were recruited during their routine visits. Patients' disease severities were evaluated by their physicians using the Partial Mayo Score (pMayo). Patients were requested to fill in the Inflammatory Bowel Disease Questionnaire (IBDQ), EQ-5D, and the Work Productivity and Activity Impairment (WPAI), to assess their HRQOL and impairment in their daily work and activity. A total of 319 out-patients were enrolled from 12 health facilities. The mean age was 46 years old and 54% of patients were male. Of these, 60% of patients were in remission, 23% had a mild disease, and 18% had a moderate-to-severe disease based on the pMayo. The mean IBDQ scores were 190.5, 165.8 and 149.7 in remission, mild, and moderate-to-severe disease, respectively and these scores were statistically significant (P<0.001). The mean EQ-5D scores were also significantly lower in patients with moderate-to-severe symptoms than those in remission (mean=0.93, 0.86 and 0.79 in remission, mild and moderate-to-severe, respectively, p<0.001). A similar finding was observed with WPAI scores, where patients with moderate-to-severe disease symptoms had the largest impairment in both work and daily activity. The study demonstrated that UC disease severity is associated with patients' HRQOL. The more severe a level of disease the patients had, the greater impairment in HRQOL and work productivity patients experienced.

No Superiority of Tacrolimus Suppositories vs Beclomethasone Suppositories in a Randomized Trial of Patients With Refractory Ulcerative Proctitis

Ulcerative proctitis (UP) refractory to 5-aminosalicylic acid (5-ASA) suppositories is a challenge to treat, often requiring step up to immunomodulator or biological therapy. Topical tacrolimus is effective and safe in patients with refractory UP. However, it is not clear how tacrolimus suppositories fit into in the treatment algorithm of UP. We performed a randomized controlled, double-blind study at 8 hospitals in the Netherlands and Belgium from 2014 through 2017. Eighty-five patients with refractory UP (65% women) were randomly assigned to groups given once daily tacrolimus suppositories (2 mg; n= 43) or beclomethasone (3 mg; n= 42) for 4 weeks. The primary outcome was clinical response (decrease in Mayo score of 3 or more). Secondary outcomes included clinical remission, endoscopic response and remission, adverse events and quality of life. Outcomes were compared using Fisher's exact test and Mann-Whitney U test. Proportions of patients with clinical responses were 63% in the tacrolimus group and 59% in the beclomethasone group (P= .812); proportions of patients in clinical remission were 46% and 38%, respectively (P= .638). Proportions of patients with an endoscopic response were 68% and 60% in the tacrolimus group and in the beclomethasone group (P= .636); proportions in endoscopic remission rates were 30% and 13%, respectively (P= .092) Median increases in the inflammatory bowel disease questionnaire score were 18.0 in the tacrolimus group and 20.5 in the beclomethasone group (P= .395). Adverse event rates did not differ significantly between groups. In a 4-week randomized controlled trial, tacrolimus and beclomethasone suppositories induce comparable clinical and endoscopic responses in patients with UP refractory to 5-ASA. There were no significant differences in adverse events rates. Tacrolimus and beclomethasone suppositories are therefore each safe and effective treatment options for 5-ASA refractory disease. EUDRACT 2013-001259-11; Netherlands Trial Register NL4205/NTR4416.

690 Ustekinumab Maintained Clinically Meaningful Improvement in Health-Related Quality of Life in Patients With Moderate to Severe Crohn's Disease: Results From the IM-UNITI Long-Term Extension

INTRODUCTION: The IM-UNITI study evaluated the safety and efficacy of subcutaneous (SC) ustekinumab (UST) maintenance therapy in patients with moderately to severely active Crohn's disease (CD) who completed induction treatment with UST. Previously, we reported the effects of UST on health-related quality of life (HRQoL) through Wk44. Here, we evaluated HRQoL through Wk140 in patients who entered the long-term extension of the IM-UNITI study. METHODS: Patients who completed the safety and efficacy evaluation at Wk 44 of the maintenance study were eligible to continue their regimen in the extension study (placebo [PBO], UST 90 mg q12w, or UST 90 mg q8w). All patients who were treated in the extension study were included in this analysis of Inflammatory Bowel Disease Questionnaire (IBDQ) and SF-36 data according to the treatment they received during the extension study. The IBDQ is a 32-item questionnaire with 4 dimensions: bowel symptoms, systemic symptoms, emotional function, and social function. The total score ranges from 32 to 224, higher scores indicate better quality of life, and a change ≥16 points was defined as clinically meaningful. For SF-36, a change ≥5 points was defined as clinically meaningful. RESULTS: For patients who entered the extension, mean total IBDQ scores and SF-36 scores at maintenance baseline were comparable across treatment groups (Table 1). Patients who received UST maintained the improvement in IBDQ and SF-36 that was achieved by maintenance baseline through Wk140, and those who received PBO generally worsened. Through Wk 140, 26.5% of patients receiving PBO, 61.5% of patients receiving UST 90 mg q12w, and 59.3% of patients receiving UST 90 mg q8w had ≥16-point improvements from induction baseline in IBDQ score. In addition, 10.9%, 51.6%, and 54.2%, respectively, had ≥5-point improvements in SF-36 physical component summary scores, and 8.7%, 43.8%, and 43.7%, respectively, had ≥5-point improvements in SF-36 mental component summary scores during the same period. CONCLUSION: In patients who entered the long-term extension of the IM-UNITI study, those who received SC UST maintenance generally maintained improvements in IBDQ and SF-36 scores that were achieved through IV induction, and those who received PBO gradually lost these improvements.

2913 Health-Related Quality of Life in Patients With Inflammatory Bowel Disease at the University Hospital of the West Indies

INTRODUCTION: Inflammatory bowel disease (IBD) is a chronic condition that can significantly affect health-related quality of life (HRQoL). The aim of this study is to determine the HRQoL of patients with IBD seen at the Gastroenterology clinic at the University Hospital of the West Indies (UHWI). METHODS: A cross sectional study was conducted, which included seventy patients with IBD (CD 25, UC 44 and one patient with Indeterminate colitis). Data analyses were restricted to 69 patients who had CD or UC. All the patients completed the validated Inflammatory Bowel Disease Questionnaire (IBDQ) and a questionnaire with demographic data. Disease activity was measured using Crohn's Disease Activity Index (CDAI) for CD and Truelove and Witts severity index for UC. Data analysis was conducted using Stata 14 statistical software. RESULTS: Mean age was 44.3 ± 16.2 years, 56.5% females, mean disease duration 12.0 ± 11.0 years and mean age at diagnosis of IBD was 31.5 ± 13.4 years. Patients with CD had more frequent hospital admissions (3.9 ± 3.7 vs 0.9 ± 1.8; P value 0.001) and surgeries (0.75 ± 0.8 vs 0.1 ± 0.4; P value 0.001) compared to those with UC. The mean total IBDQ score was 179.6 ± 34.4 (CD was 175.0 ± 37.1 and 182.1 ± 33.0 for patients with UC). Patients with higher IBDQ scores were more likely to be male gender (OR 1.93, 95% CI 0.69–5.39, P value 0.207), married (OR 2.25, 95% CI 0.60-7.31, P value 0.177), educated to secondary school level (OR 2.05, 95% CI 0.46-9.06, P value 0.343), employed in the private sector (OR 3.00, 95% CI 0.83-10.90, P value 0.095) and on no medications (OR 3.24, 95% CI 0.27–0.80, P value 0.006). Higher IBDQ score was associated with fewer hospital admissions (OR 0.90, 95% CI 0.73-1.10, P value 0.287). The best score was seen in the systemic domain. The lowest score was seen in emotional domain for both diseases. Overall male patients had a better score for all domains. CONCLUSION: The HRQoL for patients with IBD at the UHWI was comparable to those in other studies. Patients with UC and male gender appeared to have better quality of life, but comparisons were limited by small sample size.

701 Item-Level Improvements in Inflammatory Bowel Disease Questionnaire Scores in Patients With Ulcerative Colitis Treated With Tofacitinib Induction Therapy

INTRODUCTION: Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Significant improvements have been reported in all Inflammatory Bowel Disease Questionnaire (IBDQ) domains for tofacitinib vs placebo (PBO) in patients (pts) with UC in OCTAVE Induction 1 &amp; 2 and OCTAVE Sustain. 1 The effect of tofacitinib on items within each IBDQ domain has not yet been analyzed. METHODS: We examined the effect of tofacitinib induction (10 mg twice daily [BID]) on individual IBDQ items in adults with moderate to severe UC. Data were pooled from the randomized, Phase 3 OCTAVE Induction 1 &amp; 2 studies (NCT01465763 &amp; NCT01458951). 2 Pts self-administered the IBDQ at baseline (BL), Week (Wk) 4, and Wk 8. IBDQ domains are: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items); higher scores indicate better health-related quality of life (HRQoL). 1,3 Change from BL (CFB) in IBDQ items was analyzed for tofacitinib vs PBO using a linear mixed-effects model, with fixed effects (treatment, study, prior tumor necrosis factor inhibitor treatment, BL corticosteroid use, geographical region, week, treatment-by-week interaction, and BL score) and a random effect (pts). No multiplicity adjustment was performed. RESULTS: Significant improvements (P &lt; 0.05) were observed in all IBDQ items with tofacitinib 10 mg BID vs PBO at Wks 4 and 8. The largest treatment differences (CFB; domain) were: “bowel movements been loose” at Wks 4 and 8 and also “problem with rectal bleeding” at Wk 8 (all 1.1 points) for the bowel symptoms domain; “getting a good night's sleep” at Wk 4 (0.8) and 8 (0.9) for the systemic symptoms domain; “fear of not finding a washroom” at Wk 4 (0.6) and 8 (0.8) and also “felt embarrassed” and “felt angry” at Wk 4 (both 0.6) for the emotional function domain; and “avoid attending events” at Wk 4 (0.8) and 8 (1.0) and also “difficulty doing leisure/sports” at Wk 8 (1.0) for the social function domain (Table 1). CONCLUSION: Tofacitinib improved all bowel-related and systemic symptoms, and all emotional and social functioning IBDQ items vs PBO, highlighting the broad impact of tofacitinib on HRQoL. This analysis provides a useful perspective on the most improved IBDQ domains with tofacitinib induction therapy, which may facilitate patient-physician dialogue.

Unmet Psychosocial Needs of Patients with Newly Diagnosed Ulcerative Colitis: Results from the Nationwide Prospective Cohort Study in Korea.

Background/AimsLimited data are available regarding psychosocial distress at the time of diagnosis of ulcerative colitis (UC). We investigated the psychosocial burden and factors related to poor health-related quality of life (HRQL) among patients newly diagnosed with moderate-to-severe UC who were affiliated with the nationwide prospective cohort study.MethodsWithin the first 4 weeks of UC diagnosis, all patients were assessed using the Hospital Anxiety and Depression Scale (HADS), Work Productivity and Activity Impairment questionnaire, Inflammatory Bowel Disease Questionnaire (IBDQ), and 12-Item Short Form (SF-12) health survey. A multiple linear regression model was used to identify factors associated with HRQL.ResultsBetween August 2014 and February 2017, 355 patients completed questionnaires. Significant mood disorders requiring psychological interventions, defined by a HADS score ≥11, were identified in 16.7% (anxiety) and 20.6% (depression) of patients. Patients with severe disease were more likely to have presenteeism, loss of work productivity, and activity loss than those with moderate disease (all p<0.05). Significant mood disorders had the strongest negative relationship with total IBDQ score, which indicates disease-specific HRQL (β coefficient: –22.1 for depression and –40.0 for anxiety, p<0.001). The scores of all SF-12 dimensions, which indicate general HRQL, were remarkably decreased in the study population compared indirectly with previously reported scores in the general population. The Mayo score, C-reactive protein level, and white blood cell count showed significant negative associations with the IBDQ score (p<0.05).ConclusionsPsychosocial screening and timely interventions should be incorporated into the initial care of patients newly diagnosed with UC.

Prospective cohort study of appendicectomy for treatment of therapy-refractory ulcerative colitis.

Appendicectomy may reduce relapses and need for medication in patients with ulcerative colitis, but long-term prospective data are lacking. This study aimed to analyse the effect of appendicectomy in patients with refractory ulcerative colitis. In this prospective multicentre cohort series, all consecutive patients with refractory ulcerative colitis referred for proctocolectomy between November 2012 and June 2015 were counselled to undergo laparoscopic appendicectomy instead. The primary endpoint was clinical response (reduction of at least 3 points in the partial Mayo score) at 12 months and long-term follow-up. Secondary endpoints included endoscopic remission (endoscopic Mayo score of 1 or less), failure (colectomy or start of experimental medication), and changes in Inflammatory Bowel Disease Questionnaire (IBDQ) (range 32-224), EQ-5D™ and EORTC-QLQ-C30-QL scores. A total of 28 patients (13 women; median age 40·5 years) underwent appendicectomy. The mean baseline IBDQ score was 127·0, the EQ-5D™ score was 0·65, and the EORTC-QLQ-C30-QL score was 41·1. At 12 months, 13 patients had a clinical response, five were in endoscopic remission, and nine required a colectomy (6 patients) or started new experimental medical therapy (3). IBDQ, EQ-5D™ and EORTC-QLQ-C30-QL scores improved to 167·1 (P < 0·001), 0·80 (P=0·003) and 61·0 (P < 0·001) respectively. After a median of 3·7 (range 2·3-5·2)years, a further four patients required a colectomy (2) or new experimental medical therapy (2). Thirteen patients had a clinical response and seven were in endoscopic remission. The improvement in IBDQ, EQ-5D™ and the EORTC-QLQ-C30-QL scores remained stable over time. Appendicectomy resulted in a clinical response in nearly half of patients with refractory ulcerative colitis and a substantial proportion were in endoscopic remission. Elective appendicectomy should be considered before proctocolectomy in patients with therapy-refractory ulcerative colitis.

Intestinal Permeability Measured by Urinary Sucrose Excretion Correlates with Serum Zonulin and Faecal Calprotectin Concentrations in UC Patients in Remission.

Background and Aims Ulcerative colitis (UC) is associated with an increased intestinal permeability, possibly through a dysbiosis of intestinal bacteria. We investigated which markers are most relevant to assess intestinal permeability in UC patients and whether probiotics had an effect on these markers. Methods In this twelve-week placebo-controlled randomized double-blind study, twenty-five subjects with UC in remission received either placebo or a multispecies probiotics. Samples of blood, urine, and faeces were taken at baseline, week 6, and week 12 to assess intestinal permeability and inflammation. Diaries and Bristol stool scale were kept to record stool frequency and consistency. Quality of life was scored from 32–224 with the inflammatory bowel disease questionnaire (IBD-Q). Results This group of UC patients, in clinical remission, did not show increased intestinal permeability at baseline of this study. During the study, no significant group or time effects were found for intestinal permeability measured by the 5-sugar absorption test, serum zonulin, and faecal zonulin. Likewise, the inflammatory markers C-reactive protein (CRP), calprotectin, and the cytokines IFNγ, TNFα, IL-6, and IL-10 were not significantly affected. Stool frequency and consistency were not significantly affected either. The IBD-Q score, 194 for the probiotics group and 195 for the placebo group, remained unaffected. Correlations were tested between all outcomes; urinary sucrose excretion was significantly correlated with serum zonulin (r = 0.62) and faecal calprotectin (r = 0.55). Faecal zonulin was not significantly correlated with any of the other markers. Conclusion Serum zonulin may be a more relevant biomarker of intestinal permeability than faecal zonulin, due to its correlation with other biomarkers of intestinal permeability. UC patients in remission did not show an effect of the probiotic treatment or a change in gut permeability. This should not discourage further studies because effects might be present during active disease or shortly after a flare up.

Presence of Irritable Bowel Syndrome Symptoms in Quiescent Inflammatory Bowel Disease Is Associated with High Rate of Anxiety and Depression

Inflammatory bowel disease (IBD; Crohn's disease, CD and Ulcerative colitis, UC) and irritable bowel syndrome (IBS) have overlapping symptoms. Few prevalence studies of IBS in quiescent IBD have used colonoscopy with histology to confirm inactive disease. The aims were (1) to determine the percentage of IBD patients in deep remission whose persistent IBS-like symptoms (IBD/IBS+) would cause them to be classified as having active disease, based on the calculation of Harvey Bradshaw Index (HBI) or UC disease activity index (UCDAI); (2) to identify demographic and disease characteristics that are associated with IBD/IBS+. This was a prospective study at a single tertiary care IBD center. 96/112 patients with colonoscopy and histology confirmed quiescent disease consented and completed Rome III criteria for IBS Survey, and the hospital anxiety and depression scale (HADS). Other demographic and disease specific data were collected. 36% (28/77) and 37% (7/19) of CD and UC patients, respectively, met diagnostic criteria for IBS. Significantly higher HBI/UCDAI scores (p = 0.005) and low short inflammatory bowel disease questionnaire (SIBDQ) scores (p ≤ 0.0001) were seen in IBD/IBS+ patients. 29% of patients in deep remission were mis-categorized by HBI/UCDAI as having active disease when they fulfilled Rome III criteria for IBS. Psychiatric diagnosis (OR 3.53 95% CI 1.2-10.2) and earlier onset of IBD (OR 1.056 95% CI 1.015-1.096) were associated with IBD/IBS+. Patients fulfilling IBS criteria had higher hospital anxiety and depression scale (HADS). IBD/IBS+ affect scoring of IBD disease activity scales and become less useful in guiding treatment plans.

Cost-effectiveness of laparoscopic ileocaecal resection versus infliximab treatment of terminal ileitis in Crohn’s disease: the LIR!C Trial

ObjectiveEvaluate the cost-effectiveness of laparoscopic ileocaecal resection compared with infliximab in patients with ileocaecal Crohn’s disease failing conventional therapy.DesignA multicentre randomised controlled trial was performed in 29 centres in The...

Randomized controlled trial: a pilot study of a psychoeducational intervention for fatigue in patients with quiescent inflammatory bowel disease.

Introduction:Fatigue is a frequent, debilitating symptom of inflammatory bowel disease (IBD). Despite this, studies report dissatisfaction among IBD patients regarding how little attention is given to fatigue-related issues during consultations. We performed a pilot randomized controlled trial (RCT) to assess whether a brief, structured, multidisciplinary psychological support program improved fatigue, mood and quality of life indices in patients with quiescent IBD.Methods:The intervention consisted of three small-group psychoeducational sessions over 6 months. Primary outcomes were effect on fatigue severity and impact scores. Secondary outcomes included effect on depression, anxiety, somatization scores, generic and disease-specific quality of life.Results:Twenty-three patients were enrolled, 10 in the intervention arm and 13 controls. Mean fatigue severity and impact scores improved for patients in the intervention group (by 14.5–13.1 and 49.7–45.8, respectively), and worsened in controls (by 11.5–12.6 and 33.5–35 respectively). Mean Short Form 36 (SF-36) scores for role limitations due to physical health decreased from 44.4 to 38.9 in the intervention group, but increased from 44.2 to 51.9 among controls. Energy scores in the intervention group improved from 17.8 to 26.6, but only from 31.4 to 31.7 among controls. Short IBD questionnaire scores improved in both groups, from 46.2 to 45.2 in controls compared with 44.4–40 in the intervention group.Discussion:In this small pilot RCT, positive effects were demonstrated on fatigue, energy levels and other quality of life outcomes. Larger, adequately powered studies with longer follow up are required.ClincialTrials.gov identifier: NCT02709434.

Regulation of faecal biomarkers in inflammatory bowel disease patients treated with oral mastiha (Pistacia lentiscus) supplement: A double-blind and placebo-controlled randomised trial.

There is a keen research upon the effects of nutraceuticals on inflammatory bowel disease. The purpose of this study was to explore the effect of mastiha supplement, rich in bioactive nutraceuticals, in active inflammatory bowel disease. This is a randomised, double-blind, placebo-controlled clinical trial. Α total of 60 inflammatory bowel disease patients were enrolled and randomly allocated to mastiha (2.8g/day) or placebo groups for 3months adjunct to stable medical treatment. Medical and dietary history, Inflammatory Bowel Disease Questionnaire (IBDQ), Harvey-Bradshaw index, partial Mayo score, biochemical indices, faecal, and blood inflammatory markers were assessed. A clinically important difference between groups in IBDQ was defined as primary outcome. Inflammatory Bowel Disease Questionnaire score significantly improved in verum compared with baseline (p=0.004). There was a significant decrease in faecal lysozyme in mastiha patients (p=0.018) with the mean change being significant (p=0.021), and significant increases of faecal lactoferrin (p=0.001) and calprotectin (p=0.029) in the placebo group. Fibrinogen reduced significantly (p=0.006) with a significant mean change (p=0.018), whereas iron increased (p=0.032) in mastiha arm. Our results show regulation of faecal lysozyme by mastiha supplement adjunctive to pharmacological treatments in active inflammatory bowel disease. An effect secondary to a prebiotic potency is proposed.

Systematic review with network meta-analysis: the impact of medical interventions for moderate-to-severe ulcerative colitis on health-related quality of life.

Patient-reported outcomes are important in the assessment of efficacy of intervention for ulcerative colitis (UC). To compare the impact of interventions for moderate-to-severe UC on health-related quality of life (HRQL). We searched Medline, Embase, CENTRAL and grey literature sources through October 2017. We included randomised controlled trials (RCTs) that compared infliximab, adalimumab, golimumab, vedolizumab or tofacitinib to each other or placebo. Outcomes included the change in quality of life scores and the proportion of patients with improvement in quality of life. We performed random-effect pairwise and network meta-analysis. We assessed confidence in estimates using the CINeMA (Confidence in Network Meta-Analysis) framework. Fourteen RCTs assessed HRQL using the Inflammatory Bowel Disease Questionnaire (IBDQ) (14 trials), the Short Form questionnaire-36 (SF-36) (seven trials) or the European Quality of Life-5 Dimensions questionnaire (EQ-5D) (three trials). At induction (13 trials), low to very low confidence evidence suggested that all agents significantly improved both generic and disease-specific HRQL scores compared to placebo. However, only infliximab (MD 18.58; 95% CI 13.19-23.97) and vedolizumab (MD 18.00; 95% CI 11.08-24.92) showed clinically meaningful improvement in IBDQ score. Differences among individual interventions were imprecise. For maintenance (four trials), very low confidence evidence suggested that vedolizumab, tofacitinib and adalimumab maintained improvement in HRQL. Induction treatment with infliximab, adalimumab, golimumab, vedolizumab or tofacitinib improves quality of life compared to placebo. Evidence on maintenance therapy is sparse and uncertain. Head-to-head comparisons could enhance confidence in conclusions about differences between drugs in terms of HRQL.

Cognitive-behavioural therapy in patients with inflammatory bowel diseases: A systematic review and meta-analysis.

This systematic review and meta-analysis aimed to evaluate the effects of cognitive-behavioural therapy in patients with inflammatory bowel diseases. Cochrane Library, Web of Science, Pubmed, EMBASE, and CINAHL were searched up to June 2017, as well as grey literature and databases hand searches. Quality assessment, heterogeneity, sensitivity analysis, and publication bias were performed. Stata12.0 software was used for pooled estimates. Seven eligible reports were included in the final analysis. Inflammatory Bowel Disease Questionnaire score was higher in the cognitive-behavioural therapy group than in the control group at the final follow-up in inflammatory bowel disease patients (P=0.008). There was no statistically significant difference in the Crohn's Disease Activity Index (P=0.751), Simple Clinical Colitis Activity Index score (P=0.747), State Anxiety score (P=0.988), Trait Anxiety score (P=0.681), and Perceived Stress Questionnaire score (P=0.936) at the final point of follow-up. A funnel plot showed no publication bias (P=0.98). Cognitive-behavioural therapy appeared to support higher quality of life in inflammatory bowel disease patients compared with a control group at the final follow-up point but had no effect on disease activity, anxiety, or perceived stress in patients with inflammatory bowel disease. Cognitive-behavioural therapy can be an acceptable adjunctive therapy for inflammatory bowel disease patients, but the effect of cognitive-behavioural therapy is limited.

Effects of psychological stress and social support on quality of life of patients with ulcerative colitis

Objective To explore effects of psychological stress and social support on quality of life of patients with ulcerative colitis(UC). Methods From February 2017 to February 2018, at the First Affiliated Hospital of Zhengzhou University, the data of 167 patients with UC were collected, which included education levels, monthly per capita income of the family, course of the disease, Mayo score and Montreal classification.Psychological stress was evaluated by perceived stress scale (PSS). Social support was assessed by social support rate scale (SSRS). Quality of life was measured by the inflammatory bowel disease questionnaire (IBDQ). Chi square test was performed for univariate correlation analysis, Pearson or Spearman correlation analysis was performed for the correlationship, and two classification logistic regression method was used for multivariate analysis. Results The PSS score was 23 (19, 31), and the SSRS score was 33.0 (29.0, 37.0), and the IBDQ score was 168.0(154.0, 183.0). The PSS score was negatively correlated with IBDQ scores (r=-0.590, P<0.01). SSRS score were positively correlated with the IBDQ score (r=0.329, P<0.01). The results of univariate correlation analysis indicated that the quality of life was higher in patients with high education, high monthly per capita income of the family, high medical insurance reimbarsement rate, clinical remission period and mild active period (χ2=4.338, 12.311, 9.896 and 25.159, all P<0.05). The results of multivariate analysis demonstrated that quality of life of patients with UC was correlated with psychological stress (odds ratio (OR)=0.871, 95% confidence interval (CI) 0.815 to 0.932), type of medical insurance (OR=2.024, 95%CI 1.168 to 3.507), social support (OR=1.065, 95%CI 1.002 to 1.132) and clinical disease activity (OR=0.362, 95%CI 0.193 to 0.679) (all P<0.05). Conclusion The quality of life of patients with UC is not only correlated with clinical activity of the disease, but also correlated with psychological stress, social support and type of medical insurance. Key words: Colitis, ulcerative; Stress, psychological; Social support; Quality of life

Continuous Clinical Response Is Associated With a Change of Disease Course in Patients With Moderate to Severe Ulcerative Colitis Treated With Golimumab

Responders to induction treatment sustain continuous clinical response (CCR) through 1 year in about 50% of patients in PURSUIT-M trial with golimumab maintenance in ulcerative colitis (UC). This post hoc analysis of PURSUIT-M describes the 1-year clinical, endoscopic, quality of life (QoL), and biomarker and 4-year clinical outcome in patients with sustained response to golimumab therapy for UC. We compared clinical, endoscopic, QoL, and calprotectin outcomes in CCR and non-CCR patients through 54 weeks in PURSUIT-M. Persistence on golimumab therapy and clinical response at 4 years was assessed for CCR and non-CCR patients. The relationship of colectomy with CCR status was determined. Among patients receiving golimumab maintenance, greater proportions of patients with vs without CCR at week 54 achieved clinical remission (67.1% vs 1.9%), corticosteroid-free remission (61.6% vs 1.9%), endoscopic remission (Mayo endoscopy score 0 [47.9% vs 1.3%]), and normal QoL (inflammatory bowel disease questionnaire score ≥170 [75.0% vs 24.4%]). CCR but not non-CCR patients maintained normalized calprotectin levels during maintenance. Among patients who entered the long-term extension study, a greater proportion of patients with vs without CCR maintained PGA 0 through week 216 (58% vs 42%). Colectomy was performed in 47 induction nonresponders and in 13 induction responders. None of the patients going onto colectomy achieved CCR through 54 weeks in PURSUIT-M. Continuous clinical response is associated with favorable short- and long-term clinical, endoscopic, QoL, and biomarker responses that may result in changing the course of disease and may prevent colectomy in patients with moderate to severe UC treated with golimumab. 10.1093/ibd/izy229_video1izy229.video15806022773001.

Long-Term Benefit of Golimumab for Patients with Moderately to Severely Active Ulcerative Colitis: Results from the PURSUIT-Maintenance Extension.

To evaluate the safety and efficacy of 3 additional years of subcutaneous golimumab maintenance in patients with moderately to severely active ulcerative colitis. The PURSUIT-maintenance long-term extension enrolled patients who had completed placebo or golimumab 50 mg or 100 mg treatment every 4 weeks [q4w] through Week 52 and evaluations at Week 54 [n = 666]; treatment continued through Week 212. Patients receiving placebo were discontinued after study unblinding. Efficacy endpoints, golimumab concentrations, and anti-drug antibodies were summarized as observed for golimumab-induction responders who continued golimumab therapy during the long-term extension. Observations relating to safety were summarized for all treated patients. Overall, 63% of patients who were receiving golimumab at the beginning of the extension remained on treatment through the end of the study. Among all treated patients in the extension, rates of adverse events of special interest [e.g. tuberculosis, demyelination, and malignancy] were infrequent. Nine deaths occurred during the extension [1 placebo, 1 golimumab 50 mg, and 7 golimumab 100 mg]. Serum golimumab concentrations were dose-proportional and were maintained over time. During the extension through Week 228, anti-drug antibody rates with golimumab 50 mg and 100 mg were 4.4% and 3.7%, respectively. Among golimumab-induction responders, 99.3% had no disease or mild disease activity as per the Physician's Global Assessment, 92.5% were corticosteroid-free, and 76.1% had an Inflammatory Bowel Disease Questionnaire score of ≥170 at Week 216. Subcutaneous golimumab treatment of moderately to severely active ulcerative colitis for up to 3 additional years during the extension maintained clinical benefit with no new safety signals observed.ClinicalTrials.gov number NCT00488631.

Development and validation of the Crohn\u2019s disease patient-reported outcomes signs and symptoms (CD-PRO/SS) diary

BackgroundThe clinical course of Crohn’s disease (CD) and the effect of its treatment are monitored through patient-reported signs and symptoms (S&S), and endoscopic evidence of inflammation. The Crohn’s Disease Patient-reported Outcomes Signs and Symptoms (CD-PRO/SS) measure was developed to standardize the quantification of gastrointestinal S&S of CD through direct report from patient ratings.MethodsThe CD-PRO/SS was developed based on data from concept elicitation (focus groups, interviews; n = 29), then refined through cognitive interviews of CD patients (n = 20). Measurement properties, including item-level statistics, scaling structure, reliability, and validity, were examined using secondary analyses of baseline and two-week clinical trial data of adults with moderate-to-severe CD (n = 238).ResultsFindings from qualitative interviews identified nine S&S items covering bowel and abdominal symptoms. The final CD-PRO/SS daily diary includes two scales: Bowel S&S (three items) and Abdominal Symptoms (three items), each scored separately. Each scale showed evidence of adequate reliability (α = 0.74 and 0.67, respectively); reproducibility (intraclass correlation coefficient > 0.80), and validity, with the last including moderate correlations with the Inflammatory Bowel Disease Questionnaire bowel symptom score and select items (ranging from r = 0.43–0.54). Scores distinguished patients categorized by patient global ratings of disease severity (p < 0.0001).ConclusionsResults suggest the CD-PRO/SS is a reliable and valid measure of gastrointestinal symptom severity in CD patients. Additional longitudinal data are needed to evaluate the ability of the CD-PRO/SS scores to detect responsiveness and inform the selection of responder definitions.

Reduced Unplanned Care and Disease Activity and Increased Quality of Life After Patient Enrollment in an Inflammatory Bowel Disease Medical Home

Specialty medical homes (SMHs) are a new health care model in which a multidisciplinary teamand specialists manage patients with chronic diseases. As part of a large integrated payer-provider network, we formed an inflammatory bowel diseases (IBDs) SMH and investigated its effects on health care use, disease activity, and quality of life (QoL). We performed a retrospective analysis of 322 patients (58% female; mean age, 34.6 y; 62% with Crohn's disease; 32% with prior IBD surgery) enrolled in an IBD SMH, in conjunction with the University of Pittsburgh Medical Center Health Plan, from June 2015 through July 2016. Patients had at least 1 year of follow up. We evaluated changes in numbers of emergency department visits and hospitalizations from the year before vs after SMH enrollment. Secondary measures included IBD activity assessments and QoL. Compared to the year before IBD SMH enrollment, patients had a 47.3% reduction in emergency department visits (P < .0001) and a 35.9% reduction in hospitalizations (P= .008). In the year following IBD SMH enrollment, patients had significant reductions in the median Harvey-Bradshaw Index score (reduced from 4 to 3.5; P= .002), and median ulcerative colitis activity index score (from 4 to 3; P= .0003), and increases in QoL (median short inflammatory bowel disease questionnaire score increased from 50 to 51.8; P < .0001). Patients in the most extreme (highest and lowest) quartiles had the most improvement when we compared scores at baseline vs after enrollment. Based on multivariable regression analysis, use of corticosteroids (odds ratio [OR], 2.72; 95% CI, 1.32-5.66; P= .007) or opioids (OR, 3.20; 95% CI, 1.32-7.78; P= .01), and low QoL (OR, 4.44; 95% CI, 1.08-18.250; P= .04) at enrollment were significantly associated with persistent emergency department visits and hospitalizations. We found development of an IBD SMH to be feasible and significantly reduce unplanned care and disease activity and increase patient QoL 1 year after enrollment.

Stem Cell Therapy in Refractory Perineal Crohn's Disease: Long-term Follow-up.

To describe the long-term outcomes of adipose-mesenchymal stem cells, platelet-rich plasma, and endorectal advancement flaps in patients with Perineal Crohn's Disease. This was a single-center, prospective, observational pilot study performed between March 2013 and December 2016. The study included adult patients diagnosed with Perianal Crohn's Disease (with complex perianal fistulas) refractory to previous surgical and/or biological treatment. Patients underwent surgical treatment in two stages. Stage 1: Fistula mapping, drainage, seton placement and lipoaspiration to obtain adipose-mesenchymal stem cells were performed. Stage 2: The setons were removed, and the fistula tract was debrided. A small endorectal advancement flap was created, with closure of the previous internal fistula opening. Then, 100-120 million adipose-mesenchymal stem cells mixed with platelet-rich plasma were injected into the internal fistula opening and fistula tract. The study included nine patients (seven females), with a median age of 36 years (r = 23-57). Eleven fistula tracks were treated, of which, two were pouch-vaginal fistulas. The median follow-up period was 31 months (r=21-37). At the end of the follow-up period, 10/11 (91%) fistulas were completely healed and 1/11 (9%) was partially healed. At the end of this period, there was no evidence of fistula relapse or adverse reactions in any patients. The Perianal Disease Activity Index and Inflammatory Bowel Disease Questionnaire scores significantly improved after the procedure. Combined therapy with adipose-mesenchymal stem cells, platelet-rich plasma and endorectal advancement flaps yielded good results in patients with refractory Perineal Crohn's Disease. This article is protected by copyright. All rights reserved.