Moderate Ulcerative Colitis Patients Research Articles

P833 Burden of steroid use in patients with moderate ulcerative colitis in Europe and the United States

Abstract Background Steroids are an effective short-term therapy option for induction of remission of ulcerative colitis (UC). However, long-term and frequent steroid use is common in clinical practice despite the risks of complications and adverse events.1 We aimed to describe disease burden in moderate UC patients (pts) based on their steroid use history. Methods Data were drawn from the Adelphi UC Disease Specific Programme™, a cross-sectional survey of gastroenterologists (GIs) and their pts in France, Germany, Italy, Spain, the UK and US from Jan 2020–Mar 2021. GIs reported patient demographics, clinical characteristics, treatments and healthcare resource utilization (HCRU). Pts reported quality of life (QoL) via the EQ-5D, short inflammatory bowel disease questionnaire (SIBDQ), and work productivity and activity impairment (WPAI) questionnaire. Pts had received 5-ASA or immunomodulator with no biologic or Janus kinase inhibitor in the 90 days following treatment initiation, had a history of physician-assessed moderate disease severity or a Mayo endoscopic subscore of 2, and no history of colectomy. Pts were categorized as: no steroids (NS; never received steroids), short term/intermittent (ST/I; currently receiving intermittent steroids or received steroids within the last two years for <90 days), or long term/escalated (LT/E; received steroids for ≥90 days within the last two years or had undergone steroid dose escalation within their current course). Analyses were descriptive. Results Overall, 217NS, 88 ST/I and 172 LT/E pts were analysed (Table 1). Median (interquartile range) total steroid use duration was 4.1 (1.6–22.3) months for ST/I and 14.9 (5.8–36.7) months for LT/E. NS (24.4%), ST/I (25.0%) and LT/E (26.2%) pts experienced abdominal pain; 0.5%, 4.6% and 5.2% had severe/extremely severe pain, respectively. Non-bloody diarrhoea was reported by 16.6%, 14.8%, 20.9% of pts, respectively. In the last 12 months, mean (standard deviation; SD) number of health care visits for NS, ST/I and LT/E was 6.1 (6.2), 7.3 (4.8), 8.0 (7.1); mean (SD) number of tests was 20.8 (17.2), 23.3 (15.7), 25.2 (18.2), respectively. NS, ST/I and LT/E patients reported mean EQ-5D scores (0.85, 0.81, 0.79), SIBDQ total scores (54.6, 49.7, 48.3) and overall work impairment (19.4, 23.1, 27.7). Key comorbidities experienced by ST/I and LT/E were hypertension, depression and diabetes (Figure 1). Conclusion Patients with long-term or escalated steroid use had high symptom burden, frequent comorbidities, high HCRU, and poor QoL. This highlights the need for alternative treatment approaches for moderate UC patients to avoid long-term steroid use. 1. Cross R.K. Inflamm Bowel Dis. 2017;23(10):1689–1701

P658 Safety and efficacy of MH002, an optimized live biotherapeutic product, for the treatment of mild to moderate ulcerative colitis: a first-in-disease, double-blind, randomized clinical trial

Abstract Background Treatment options for patients with mild to moderate ulcerative colitis (UC) failing 5-ASA are limited. MH002 is an optimized consortium of 6 non-pathogenic, well-characterized commensal bacteria with immune modulating, wound healing and gut barrier protective effects. This study evaluated the safety, efficacy, and mechanistic effects of MH002 in mild to moderate UC. Methods In this 2:1-randomized, double-blind, placebo-controlled first-in-disease study (EudraCT 2020-001355-33), 45 patients with mild to moderate active UC (Modified Mayo Score [MMS] =4-8 but including Mayo Endoscopic Sub-score [MES] ≥2) received treatment with 400mg MH002 or placebo (PBO) once daily for 8 wks. Full colonoscopies with biopsies were performed at baseline and wk8, biopsies and endoscopy videos were scored by blinded central readers. The primary endpoint was the rate of treatment-emergent adverse events (TEAEs). Exploratory efficacy endpoints included clinical remission (MMS ≤2 with all sub-scores ≤1 and rectal bleeding sub-score =0), endoscopic improvement (MES ≤1), and UC-100 and biomarker normalisation (C-reactive protein [CRP] ≤5mg/L, faecal calprotectin [FCP] ≤250mg/kg). Changes from baseline (CFBL) in MES and stool consistency (Bristol Stool Form Scale) were also evaluated. Results MH002 was safe and well tolerated: a TEAE was reported in 11/31 (35%) patients with MH002 and in 8/14 (57%) with PBO. Most TEAEs were mild and unrelated to study treatment. Early discontinuations (7/45; 16%) occurred similarly in both groups. At wk8, patients achieved clinical remission, endoscopic improvement, and biomarker improvements at higher rates with MH002 vs PBO (Table 1). Clinical remission rates were 14% for MH002 vs 7% for PBO (Per-protocol Set [PPS]: 18% vs 0%). Significant differences in favour of MH002 over PBO were seen in the CFBL for MES at wk8 (P=0.05, 1-sided Wilcoxon) and for stool consistency at wk2 (P=0.0057, 1-sided Student t). In total, 14/45 (31%) and 36/42 (86%) patients had elevated CRP and FCP levels at baseline, resp. Of these, more patients treated with MH002 achieved normalisation at wk8 (CRP: 60% vs 25%; FCP: 36% vs 15%). Decreases in FCP and stool consistency with MH002 were observed as early as wk2 and were greater than with PBO through wk8 (Fig 1). Conclusion MH002 treatment was safe and well tolerated and resulted in clinically meaningful improvements in disease activity and inflammatory parameters. MH002 therefore represents a promising new treatment for mild to moderate UC patients insufficiently controlled with 5ASA. These results warrant further development in a phase 2/3 study.

The significance of PD-1/PD-L1 imbalance in ulcerative colitis.

To investigate the expression and significance of programmed cell death protein 1 (PD-1) and programmed cell death ligand-1 (PD-L1) in the mucosal tissues and peripheral blood of patients with ulcerative colitis (UC). Eighty patients with UC were recruited from January 2021 to August 2022 from the Shanxi Province People's Hospital. PD-1 and PD-L1 expression was assessed by immunohistochemistry in mucosal tissues. An enzyme-linked immunosorbent assay was used to measure soluble PD-1 and PD-L1 levels in peripheral blood serum, and the membrane-bound forms of PD-1 (mPD-1), (T-helper cell) Th1 and Th17, in peripheral blood were determined by flow cytometry. PD-1 expression was observed only in the monocytes of the mucosal lamina propria of UC patients, while PD-L1 was mainly located in both epithelial cells and monocytes on the cell membrane. The expression level of PD-1/PD-L1 in the monocytes and epithelial cells of mucosal lamina propria increased with disease activity (P < 0.05). The percentages of PD-1/T and PD-1/CD4+T in the peripheral blood of moderate UC patients (PD-1/T 12.83 ± 6.15% and PD-1/CD4+T 19.67 ± 9.95%) and severe UC patients (PD-1/T 14.29 ± 5.71% and PD-1/CD4+T 21.63 ± 11.44%) were higher than in mild UC patients (PD-1/T 8.17 ± 2.80% and PD-1/CD4+T 12.44 ± 4.73%; P < 0.05). There were no significant differences in PD-1/CD8+T cells between mild and severe UC patients (P > 0.05). There was a statistically significant difference in the expression level of sPD-L1 between the UC groups and healthy controls, and the expression level of sPD-L1 increased with disease severity (P < 0.05); however, there was no statistically significant difference in sPD-1 expression levels between the UC groups and healthy controls (P > 0.05). The correlation coefficients between Th1 and sPD-L1, PD-1/T, PD-1/CD4+T and PD-1/CD8+T were 0.427, 0.589, 0.486, and 0.329, respectively (P < 0.001). The correlation coefficients between Th17 and sPD-L1, PD-1/T, PD-1/CD4+T and PD-1/CD8+T were 0.323, 0.452, 0.320, and 0.250, respectively (P < 0.05). The expression level of PD-1/PD-L1 was correlated with UC disease activity, and two forms of PD-1 and PD-L1 may be used as a potential marker for predicting UC and assessing disease progression in UC patients. PD-1/PD-L1 imbalance was a significant phenomenon of UC immune dysfunction. Future research should focus on two forms of PD-1/PD-L1 signaling molecules to better understand the pathogenesis of UC and to identify potential drug therapies.

Medication Formulation Preference of Mild and Moderate Ulcerative Colitis Patients: a European Survey

Introduction: Patient adherence is a major challenge for the successful management of any chronic disease, and ulcerative colitis (UC) is no exception. Patient adherence is closely related to patient preference of medication and formulation used. Aim: The aim of this study was to investigate patient and physician perspectives around UC treatment preference. Methods: This study was conducted in France, Germany, Spain, and the UK. Physicians and UK inflammatory bowel disease (IBD) nurses answered an online questionnaire. In addition, adult mild-to-moderate UC patients, treated with oral mesalazine, were invited to answer a 30-min online survey which included a conjoint exercise. Results: 400 patients, 160 physicians, and 20 IBD nurses participated in the survey. 68% of patients were taking tablets and 32% granules. Physicians stated that from their perspective patients are more adherent to tablets than granules (76% vs. 24%), patients tended to have better relief of symptoms with tablets (69% vs. 31%), and patients found tablets to be the most convenient formulation (61% vs. 39%). From the patients’ perspective, when questioned which formulation they prefer, 58% answered tablets, 37% granules, and 5% none of these. When patients were asked about some negative attributes of tablets, the highest agreement was for “I would like to take fewer each day” (6.1/10) and “I wish I could take fewer at a time” (5.4/10). Conclusions: The majority of UC patients in this survey prefer the tablet formulation. A high strength tablet overcoming the high pill burden could be a good solution to address patient expectations.

Comparative evaluation of the effectiveness of monotherapy of ulcerative colitis with mesalazine MMX and combination therapy with non-prolonged mesalazines with rectal forms

Introduction. According to clinical guidelines, the treatment of patients with ulcerative colitis (UC) is carried out as combination therapy with mesalazine in rectal forms.The aim was to compare the effectiveness of treatment of moderate severity UC patients receiving mesalazine MMH as monotherapy and mesalazine in combination with mesalazine for rectal use.Materials and methods. Comparative clinical analysis of the results of treatment of patients with moderate UC receiving mesalazine MMX as monotherapy (1st group, 44 patients) and mesalazine in combination with mesalazine for rectal use (microclysters, suppositories) (2nd group, 40 patients) was performed.Results and discussion. After 2 weeks of therapy with mesalazine MMX, 95.0% of the 1st group patients responded to therapy with mesalazine MMX and continued treatment with it as monotherapy (without microclysters and suppositories). In Group 2, 97.2% of patients responded to mesalazine therapy and continued treatment with topical forms of mesalazine - microglia and suppositories. After 12 weeks, 87.5% of the 44 patients in Group 1 who responded to mesalazine MMX therapy and 88.9% of the 40 patients in Group 2 who responded to mesalazine therapy achieved clinical remission. After 52 weeks, 82.5% of 44 Group 1 patients and 86.1% of 40 Group 2 patients remained in clinical remission. The Meio index decreased from 7.9 ± 0.13 to 2.4 ± 0.4 points in group 1 and from 8.0 ± 0.17 to 2.3 ± 0.2 in group 2. There was no statistically significant difference in the level o laboratory indices between the groups after 12 and 52 weeks (p &gt; 0.05).Conclusion. Our study confirms that continuous regular administration of MMX mesalazine as monotherapy in doses according to the clinical guidelines is comparable in its effectiveness to combined therapy with non prolonged mesalazine and topical forms of mesalazine in patients with UC of moderate severity.

Body Composition Changes and Related Factors in Patients with Ulcerative Colitis: A Retrospective Single-Center Study in China.

BackgroundThis study retrospectively explored body composition changes and related factors in patients with ulcerative colitis (UC).Material/MethodsPatients with UC and healthy individuals who served as the healthy control at the Affiliated Hospital of Qingdao University September 2017 to August 2018 were retrospectively analyzed. Clinical data and laboratory examination indexes were collected. The skeletal muscle area (SMA) of the third lumbar vertebra cross-section, the subcutaneous fat area (SFA), and the visceral fat area (VFA) at the umbilical level were measured by computed tomography (CT), and the skeletal muscle index (SMI) was calculated to evaluate the loss of muscle mass.ResultsData from a total of 80 patients (median age, 49.49 years; 44 [55%] men) with active UC in the UC group and 80 healthy people age- and sex-matched in the healthy control group were collected. The incidence of low SMI and malnutrition was remarkably higher in the UC group than in the healthy control group (P<0.05). Low SMI was observed in 62.5% of UC patients who had a normal body mass index. Based on classification by the Truelove and Witts’ criteria, the prevalence of malnutrition in severe UC patients was remarkably higher than that in mild and moderate UC patients (P<0.05). Based on the disease extent, the prevalence of low SMI in E3 type UC was dramatically higher than that in E2 type (P=0.028).ConclusionsLoss of muscle mass was related to disease extent in patients with UC. Loss of muscle mass is more likely to be associated with malnutrition.

Effects of saffron supplementation on oxidative/antioxidant status and severity of disease in ulcerative colitis patients: A randomized, double-blind, placebo-controlled study.

Supplementation with saffron helps improve antioxidant status. Oxidative stress plays an important role in ulcerative colitis (UC). The present study aimed to investigate the effect of saffron supplementation on disease severity and Oxidative/Antioxidant factors in patients with UC. This randomized double-blinded study was conducted on 80 mild to moderate UC patients. Participants were randomly divided into intervention (100 mg saffron/daily) and placebo (100 mg maltodextrin/daily) groups. Of all the participants, 75 completed the study. After 8 weeks, there were significantly increased in the mean score of simple clinical colitis activity index questionnaire (3.83 ± 1.78 to 3 ± 1.60, p = .004), the serum levels of total antioxidant capacity (2.68 ± 0.90 to 2.79 ± 0.87, p = .016), superoxide dismutase (60.69 ± 9.59 to 66.30 ± 10.79, p = .009) and glutathione peroxidase (22.05 ± 14.27 to 29.67 ± 17.97, p = .011) in patients received saffron compared to the placebo group. Whereas, there was no significant difference in serum levels of malondialdehyde between the two groups. Finally, dietary saffron as an alternative therapy may effective in improving antioxidant factors and reducing the severity of disease in UC patients.

Inflammatory biomarkers response to two dosages of vitamin D supplementation in patients with ulcerative colitis: A randomized, double-blind, placebo-controlled pilot study

This study was designed to determine the effects of two dosages of vitamin D supplementation on inflammatory biomarkers in patients with ulcerative colitis (UC). Fifty mild to moderate active UC patients were randomly assigned to consume either 2000 or 1000 IU/day vitamin D for 12 weeks. Inflammatory biomarkers, disease activity, quality of life, anthropometric indices, dietary intakes, and physical activity were measured at the beginning and the end of the study. Serum level of hs-CRP decreased in both groups at the end of study, but the changes were not significantly different within and between groups. Serum level of TNF-α in the high dose group was reduced at the end of the study non-significantly (P-value=0.289). In the low dose group, a significant increase in serum TNF-α concentration was observed (p≤0.001). The changes in serum TNF-α were significantly different between two groups (p=0.005); however, after adjusting for the effect of confounders, the significance effect was disappeared (p=0.162). Activity of NF-κB increased in both groups while this increase was significant in the low dose group compared to the baseline (p≤0.001), and to high dose group (p=0.006). After adjustment for confounders, the difference between groups remained statistically significant (p=0.002). Our results indicate that 12 weeks supplementation with 2000 IU/day vitamin D prevents from systematic inflammation, while decreasing disease activity in patients with mild to moderate active UC. Further studies are needed to find the optimum dosage and duration of supplementation. This Trial was registered at IRCT.ir with number of IRCT 20100524004010N22.

The effectiveness of mesalazine therapy of ulcerative colitis of moderate severity in real clinical practice

Aim of the study. To compare the efficacy of treatment of patients with moderate left-sided and overall affection ulcerative colitis (UC) receiving equivalent doses of mesalazines – Mesacol and Salofalk.Materials and methods. 90 UC patients of medium severity who received mesalazine Salofalk (group 1) were included, of which 41 (45.5%) were males and 49 (54.5%) females, mean age 35.8 ± 2.5 years, and 96 UC patients of medium severity who received mesalazine Mesacol (group 2), of whom 42 (43.75%) were males and 54 (56.25%) females, mean age 37.1 ± 3.1 years. Patient follow-up time was 12 weeks. The efficacy of the therapy was assessed taking into account 1) response to therapy in 2 weeks from the beginning of therapy; 2) achievement and maintenance of clinical remission (persistent remission) within 12 weeks after the beginning of therapy. Results and discussions. After 2 weeks 78 (86,7%) patients of the 1st group responded to the therapy with mesalazine Salofalc (stool frequency decreased to 4–6 t/day, presence of pathological impurities in the stool decreased, according to laboratory indices anemia and leukocytosis decreased, and the level of CRP and ESR decreased). Twelve patients (13.3%) did not have a proper response to therapy. In the 2nd group of patients receiving Mesacol mesalazine, 80 (83,4%) out of 96 patients responded to the therapy, and 16 patients (16,6%) did not respond. After 12 weeks, 78 (86.7%) of the 90 UC Group 1 patients who responded to mesalazine Salofalk treatment still had clinical remission. The Mayo index in the group decreased from an average of 7.98 ±0.11 to 2.9 ±0.24 points. After 12 weeks, in group 2 UC patients (n = 96), 80 patients (83.4%) who responded to Mesalazine Mesacol therapy also had clinical remission. The Mayo Index in Group 2 decreased on average from 7.8 ± 0.1 to 2.8 ± 0.25 points. One year after the start of Salofalk mesalazine therapy, clinical remission remained in 76 (84.4%) of the 90 UC patients who responded to therapy, of whom 32 (35.5%) had clinical endoscopic remission. In the second group of UC patients receiving Mesacol, clinical remission remained in 78 (82.0%) out of 96 patients who responded to therapy, clinical endoscopic remission in 32 (35.5%) patients with UC. When comparing the duration of remission among UC patients receiving mesalazine Salofalk and patients receiving mesalazine Mesacol, there was no statistically significant difference (p = 0.45).Conclusion. Mesalazines remain the first line of treatment for mild and moderate UC patients. Treatment of moderately active UC should start with oral mesalazine &gt;2 g/day in combination with local mesalazine. Prolonged continuous use of Mesacol and Salofalk mesalazines for a year is comparable in efficacy.

The Effect of Vitamin D on Serum Asymmetric Dimethylarginine in Patients with Mild to Moderate Ulcerative Colitis.

Purpose: In inflammatory bowel disease increased asymmetric dimethylarginine (ADMA) levels could inhibit nitric oxide (NO) synthase. Vitamin D may increase activity and expression of endothelial NO synthase, which could be done through its possible mechanism of decreasing ADMA levels. The aim of this study is to investigate the possible effect of Vitamin D3 on serum ADMA levels in ulcerative colitis (UC) patients. Methods: Ninety mild to moderate UC patients were randomized. Each patient received one single muscular injection of 300,000IU (7500μg) Vitamin D3 (Vitamin D group) or 1ml normal saline (Placebo group). At baseline and 90 days after the intervention measurements were done. Data were analyzed using independent t-test and analysis of covariance. Baseline correlations were assessed by Pearson and Spearman correlation coefficients. Results: Following data analysis of 86 participants (40 in placebo and 46 in vitamin D group), there was no correlation between baseline ADMA with baseline vitamin D, ESR and hs-CRP at baseline (p=0.77) and at the end of study (p=0.82). Serum ADMA levels were not statistically different between two groups. Adjustment for baseline ADMA levels and baseline body mass index (BMI) did not change the results. With subgroup analyses based on gender and vitamin D level no statistical differences in ADMA levels between two groups were found. Conclusions: In this study, we found no significant changes in serum ADMA levels 3 months following a high dose vitamin D administration in mild to moderate UC patients. Further studies in vitamin D deficient patients are needed.

Vitamin D Decreases Beck Depression Inventory Score in Patients with Mild to Moderate Ulcerative Colitis: A Double-Blind Randomized Placebo-Controlled Trial

ABSTRACTThe prevalence of depression in inflammatory bowel disease (IBD) is significantly more than in controls. Some studies assessed the link between vitamin D and depression. The aim of this study was to assess the effect of vitamin D on Beck Depression Inventory (BDI) score in ulcerative colitis (UC) patients. In this double-blind randomized controlled trial, 90 mild to moderate UC patients were assigned to receive a single injection of 300,000 IU vitamin D3 or 1 ml normal saline as placebo. At baseline and 3 months later, measurements of BDI score and serum 25-OH-vitamin D3 were done. Data were compared by independent sample t test, Mann–Whitney U test, and analysis of covariance (ANCOVA). Baseline BDI scores were not statistically different between the two groups (p = .4); scores decreased in the vitamin D group after the intervention (p = .023). Further subgroup analysis regarding baseline serum vitamin D levels and adjusted for baseline BDIs revealed lowering effect of vitamin D on BDI scores only in subgroup with baseline serum vitamin D levels equal to or higher than 30 ng/ml (p < .001). In this study, there was a statistically significant reduction in BDI score in mild to moderate UC patients 3 months after 300,000 IU vitamin D3 injection. Subgroup analysis showed that patients with sufficient baseline vitamin D may benefit from supplementation more than vitamin D–deficient patients, which indicates that higher serum vitamin D levels may be needed for its antidepressant effect.

Relationship between gene polymorphisms of T cell immunoglobulin domain and mucin domain protein-3 and ulcerative colitis

Objective To investigate the relationship between gene polymorphisms of T cell immunoglobulin domain and mucin domain protein-3 (Tim-3) and ulcerative colitis (UC) in Han nationality of Zhejiang. Methods A total of 391 UC patients and 573 healthy controls were recruited. Two single nucleotide polymorphisms (SPNs) of Tim-3 (rs1036199 and rs10515746) were examined by the improved multiple ligase detection reaction technique. Chi-square test or Fisher′s exact test was performed to analyze the differences in the distribution of Tim-3 gene polymorphisms and its influence on the location and severity. Haploview 4.2 software was used to analyze linkage disequilibrium (LD) and haplotype. Results The frequencies of genotype CA+ AA and mutant allele A of rs10515746 in UC were lower than those in healthy controls (1.79%, 7/391 vs 4.19%, 24/573; 0.90%, 7/782 vs 2.18%, 25/1 146; χ2= 4.295 and 4.712, P=0.038 and 0.030). However, there was no significant differences in frequencies of genotype CA+ CC and mutant allele C of gene rs1036199 between UC patients and the healthy controls (1.79%, 7/391 vs 3.49%, 20/573; 0.90%, 7/782 vs 1.74%, 20/1 146; both P>0.05). The frequencies of genotype CA+ AA and mutant allele A of rs10515746 in mild and moderate UC patients were both higher than those in severe UC patients (2.87%, 7/244 vs 0; 1.43%, 7/488 vs 0), and the differences were statistically significant (Fisher′s exact test, P=0.049 and 0.048). The analysis for LD indicated that rs1036199and rs10515746 were close LD (D′=0.92, r2=0.72). Furthermore, the frequency of haplotype CA formed by the mutant alleles C and A of these two SNPs was lower in UC patients than that in healthy controls (0.64%, 5/782 vs 1.74%, 20/1 146), and the difference was statistically significant (χ2=4.441, P=0.035). Conclusions Tim-3 (rs10515746) gene mutation may not only decrease the incidence, but also reduce the severity of UC. Moreover, the haplotype CA formed by the mutant alleles of rs1036199 and rs10515746 may also reduce the incidence of UC. Key words: T cell immunoglobulin domain and mucin domain protein-3; Colitis, ulcerative; Gene; Polymorphism, single nucleotide

Real life results in using 5-ASA for maintaining mild to moderate UC patients in Japan, a multi-center study, OPTIMUM Study

BackgroundEfficacy of maintenance therapy in ulcerative colitis (UC) in the remission stage has been reported to depend on release profile or dosing regimen of oral 5-aminosalicylic acid (5-ASA) products used. Aim of this study is to investigate real life results in using oral 5-ASA products for maintaining mild to moderate UC patients in Japan.MethodsAdult UC outpatients treated with oral 5-ASA products were enrolled from 379 sites in Japan between July 2012 and July 2013, and followed for 52 weeks. Remission maintenance rate was evaluated by products and dosages. Factors affecting recurrence were also examined.ResultsA total of 5695 UC patients were registered. Among the 4677 patients in whom remission maintenance was observed, remission maintenance rate at week 52 was 80.2%. As for disease duration and dosage, Pentasa® 4000 mg/day in 2 divided doses was administered to 480 (21.0%) patients in remission and 341 (46.6%) patients in active stage, and Asacol® 3600 mg/day in 3 divided doses was administered to 696 (46.4%) patients in remission and 473 (67.3%) patients in active stage.The remission maintenance rate at week 52 by dosage and frequency did not significantly differ between Pentasa® Tablets at 4000 mg/day in 2 divided doses (76.5%) and Asacol® Tablets at 3600 mg/day in 3 divided doses (76.1%, P = 0.7868).Factors affecting the risk of relapse in UC were identified. Significantly persistent remission maintenance was noted in patients in whom duration of remission maintenance until enrollment was 12 to <24 months or ≥24 months relative to the reference category of <3 months (12 to <24 months: HR 0.600 [0.486–0.740], p < 0.0001]; ≥24 months: HR 0.352 [0.289–0.431], p < 0.0001).ConclusionsEfficacy of real life results in using oral 5-ASA products for maintaining mild to moderate UC patients was favorable. Maintaining remission for 12 months or longer after induction therapy was shown to reduce recurrence risk thereafter.Trial registrationUMIN 000008563 (the date of registration: July 30, 2012), ClinicalTrials.gov NCT01654783 (the date of registration: July 30, 2012)

PP051-MON: Energy Metabolism of Severe and Moderate Ulcerative Colitis Patients

PP051-MON: Energy Metabolism of Severe and Moderate Ulcerative Colitis Patients

Effects of Jianpi herbal suppository on hemorheology and CD62p in patients with ulcerative colitis

ObjectiveTo compare the effects of a Chinese herbal suppository (Jianpi suppository) and Western Medicine (mesalazine) on hemorheology and CD62p in patients with ulcerative colitis (UC). MethodsIn a randomized trial, 120 mild to moderate UC patients were randomly divided into two equal groups. The Jianpi suppository group used Chinese herbal suppository rectally, while the mesalazine group was treated with mesalazine tablets orally. Two 15-day courses of treatment were carried out in both groups. Changes in the hemorheology and CD62p indices in patients were observed. ResultsThe hemorheology and CD62p indices in the Jianpi suppository group decreased significantly more than those of the mesalazine group. ConclusionJianpi suppository is effective in improving the hypercoagulability of UC patients, and therefore may be worth using in clinical practice.

Medical resource utilization and associated costs in patients with ulcerative colitis in the UK

Limited evidence is available on the economic burden of ulcerative colitis (UC) in the UK, particularly relating to the impact of relapse frequency on direct medical costs. This study identifies and assesses medical resource utilization (MRU) and associated direct costs in mild and moderate UC patients in the UK. A retrospective chart review of patients with mild-to-moderate UC diagnosed at least 1 year before the study was performed. From 33 general practitioner (GP) and 34 gastroenterologist sites, charts of the last three UC patients fulfilling the inclusion criteria were reviewed. Descriptive statistics were calculated for MRU and 2011 costs (GB£) by number of relapses. The study population included 201 patients with a mean age of 39.9 years; 44% were women and the mean disease duration was 7.4 years. UC-related costs of each MRU category increased with the number of relapses. Comparing patients without relapse with those with more than two relapses, the mean annual UC-related costs were £14 versus £2556 for hospitalizations; £218 versus £988 for visits (including nurse, GP, specialist, and other visits); £21 versus £1303 for procedures; £17 versus £188 for diagnostics; and £1168 versus £6660 for all-cause total costs. Age, sex, and site of data reporting (GP vs. gastroenterologist) were not associated with MRU or costs. Patients with mild-to-moderate UC incurred considerable costs that increased markedly with the number of relapses. These findings support the importance of maintenance therapies in UC that reduce or prevent relapses. Quantifying the relationship between relapse rate and costs will inform future health economic studies.

P476 Gender specific differences in quality of life in Danish paediatric patients with inflammatory bowel disease

P475 Granulocyte and Monocyte Apheresis (GMA) Adacolumn® in mild to moderate ulcerative colitis patients with steroid resistance or dependence and azathioprine intolerance or resistance: a prospective multicenter study (preliminary data) G. Imperiali1 *, M.M. Terpin2, A. Amato1, A. Bortoli3, G. Meucci4. 1Valduce Hospital, Gastroenterology, Como, Italy, 2Legnano Hospital, Gastroenterology, Legnano, Italy, 3Rho Hospital, Gastroenterology, Rho, Italy, 4S. Giuseppe Hospital, Gastroenterology, Milano, Italy

P475 Granulocyte and Monocyte Apheresis (GMA) – Adacolumn® in mild to moderate ulcerative colitis patients with steroid resistance or dependence and azathioprine intolerance or resistance: a prospective multicenter study (preliminary data)

P475 Granulocyte and Monocyte Apheresis (GMA) Adacolumn® in mild to moderate ulcerative colitis patients with steroid resistance or dependence and azathioprine intolerance or resistance: a prospective multicenter study (preliminary data) G. Imperiali1 *, M.M. Terpin2, A. Amato1, A. Bortoli3, G. Meucci4. 1Valduce Hospital, Gastroenterology, Como, Italy, 2Legnano Hospital, Gastroenterology, Legnano, Italy, 3Rho Hospital, Gastroenterology, Rho, Italy, 4S. Giuseppe Hospital, Gastroenterology, Milano, Italy

Association of death receptor 4 and death receptor 5 gene polymorphisms with ulcerative colitis susceptibility

Objective To explore the association of death receptor (DR) 4 and DR5 gene polymorphisms with ulcerative colitis (UC) susceptibility.Methods A total of 362 UC patients and 490 healthy individuals were recruited.The genotype of three locus of DR4 (rs20575,rs13278062)and DR5 (rs1047266) were detected by mini-sequencing technique (SNaPshot).Chi-square test and Fisher's exact test were performed to compare the differences in the distribution of allele and genotypic frequencies.The association of DR4 and DR5 polymorphisms with clinical pathological characteristics of UC patients was analyzed by unconditional Logistic regression analysis.Results The frequencies of variant allele G and genotype CG + GG of DR4 (rs20575) in UC group were higher than those in healthy control group (3.18％ (23/724) vs 1.63％(16/980),x2=4.439,OR=1.977,95％CI:1.037 to3.769; P=0.035; 6.08％(22/362) vs3.27％(16/490),x2=3.863,OR 1.917,95％CI:0.992 to 3.705,P=0.049).And the frequencies of variant allele G and genotype CG+GG of DR4 (rs20575) of severe UC patients were higher than those of mild and moderate UC patients (8.00％(8/100) vs 2.40％ (15/624),OR-3.530,95％CI:1.456 to 8.560,P=0.008; 16.00％(8/50) vs 4.49％(14/312),OR=4.054,95％CI:1.605 to 10.243,P=0.004).There were no significant differences in the variant allele and genotypic frequencies of DR4 (rs13278062) between UC group and healthy control group (both P＞0.05).The frequencies of variant allele T and genotype GT+TT of DR4 (rs13278062) of severe UC patients were lower than those of mild and moderate UC patients (23.00％(23/100) vs 36.06％(225/624),OR=0.530,95％CI:0.323 to 0.868,P=0.011;42.00％(21/50) vs 61.22％(191/312),OR=0.459,95％CI:0.250 to 0.8410,P=0.010).There were no significant differences in the variant allele and genotypic frequencies of DR5 (rs1047266)between UC group and healthy control group (both P＞0.05).Conclusions The risk of suffering UC increases in mutant allele G of DR4 (rs20575) carriers.The mutation of DR4 (rs13278062) gene may influence the severity of UC.However,DR5 (rs1047266) gene polymorphism is not related to UC. Key words: Colitis, ulcerative; Apoptosis; Point mutation; Alleles; Polymorphism, genetic

Medication adherence and persistence in the treatment of Canadian ulcerative colitis patients: analyses with the RAMQ database.

BackgroundAlthough high non-adherence to medication has been noticed for ulcerative colitis (UC), little is known about adherence to mesalamine treatments and determinants that can predict adherence. The objective of this study was to assess adherence and persistence to mesalamine treatments and their potential determinants in mild to moderate UC patients in a real-life setting in Quebec, Canada.MethodsA retrospective prescription and medical claims analysis was conducted using a random sample of mesalamine users with UC. For inclusion, patients were required to initiate an oral mesalamine treatment between January 2005 and December 2009. Patients with a diagnosis of Crohn’s disease were excluded. Treatment adherence (medication possession ratio [MPR]) and persistence were evaluated over a 1-year period after the index prescription using the Kaplan-Meier method with log-rank test and stepwise regression to identify potential determinants.ResultsA sample of 1,681 of the new oral mesalamine users (mean age = 55.3) patients was obtained. Overall, the percentage of patients with a MPR of 80% or greater at 12 months was 27.7%, while persistence was 45.5%. Among patients treated with mesalamine delayed/extended-release tablets (Mezavant®), adherence and persistence were 40.9% and 71.9%, respectively. Predictors of high adherence included, male gender (OR=1.3; 95% confidence interval [CI]=1.1–1.6), older age (>60 years; OR=1.6; 95% CI=1.3–2.0) and current use of corticosteroids (OR=1.4; 95% CI=1.1–1.8). Predictors of high persistence included male sex (OR=1.4; 95% CI=1.1–1.7), current use of corticosteroids (OR=1.4; 95% CI=1.1–1.7) and presence of hypertension or respiratory diseases (OR=1.2; 95% CI=1.01–1.55).ConclusionsThe majority of patients with UC exhibited low adherence and persistence to mesalamine treatments. Various determinants of improved adherence and persistence were identified.