scholarly journals P710 The influence of probiotics to the efficacy of 5-ASA for the patients of ulcerative colitis

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S573-S574
Author(s):  
R YASUDA ◽  
K Uchiyama ◽  
T Takagi ◽  
M Kubota ◽  
S Sugino ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Colonic Mucosa ◽  
Activity Index ◽  
Time Dependent ◽  
Clinical Activity ◽  
Release Formulation ◽  
Significant Difference ◽  
Ph Dependent ◽  
Disease Location ◽  
Index Disease

Abstract Background 5-ASA is a key drug to treat the patients with mild-to-moderate ulcerative colitis (UC). Probiotics is sometimes used to UC patients for the purpose to correct dysbiosis of intestine. In theory, the efficacy of 5-ASA, especially pH-dependent release formulation of mesalazine may be weakened by the co-treatment with probiotics because of its effect leading to acidic condition in large intestine. However, the detail analysis about UC patients treating with 5-ASA and probiotics has not been elucidated. In the present study, we demonstrated the clinical course of UC patients treated by 5-ASA with probiotics to investigate the effect of probiotics to 5-ASA treatment. Methods The subjects were 85 UC patients who were in clinical remission and taking 5-ASA at the hospital of Kyoto Prefectural University of Medicine from January to March 2014. The clinical characteristics (age, sex, clinical activity index, disease location, and type of 5-ASA) and the rate of relapse until October 2019 were compared between probiotics group and no probiotics group. Furthermore, the rates of relapse were analysed for each specific 5-ASA between probiotics user and no probiotics user. The clinical activity index (CAI) was determined using Lichtiger index. The relapse of UC is defined by the increase of CAI, additional medication for UC, and endoscopic deterioration of colonic mucosa. Results Patients were included 39 cases in probiotics group and 46 cases in no probiotics group. There was no significant difference between probiotics and no probiotics group on the average age (53.1 ± 16.8 vs. 51.3 ± 14.2 years old, p = 0.59), the rate of male gender (41.0% vs. 41.3%, p =0.97), the average CAI (2.1 ± 0.64 vs. 2.0 ± 0.73, p = 0.59), disease location (extensive/left/rectum: 20/7/12 vs. 21/10/15 cases, p = 0.31), and type of 5-ASA (salazosulfapyridine/time-dependent mesalazine/pH-dependent mesalazine: 5/18/16 vs. 6/18/22 cases, p = 0.46). Besides, there was no significant difference between probiotics group and no probiotics group (51.3% vs. 52.2%, p = 0.93) about the rate of relapse. Regarding each specific 5-ASA usage, there was no significant difference on salazosulfapyridine (40.0% vs. 33.3%, p = 1), time-dependent mesalazine (44.4% vs. 50.0%, p = 1), and pH-dependent mesalazine (62.5% vs. 59.1%, p = 0.90) between probiotics user and no probiotics user. Conclusion In the present study, the co-treatment with probiotics did not affect the relapse with UC patients regardless the type of 5-ASA, suggesting that the usage of probiotics might not disturb the efficacy of 5-ASA for UC patients.

scholarly journals Therapeutic Efficacy of pH-Dependent Release Formulation of Mesalazine on Active Ulcerative Colitis Resistant to Time-Dependent Release Formulation: Analysis of Fecal Calprotectin Concentration

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Kousaku Kawashima ◽  
Shunji Ishihara ◽  
Takafumi Yuki ◽  
Koji Onishi ◽  
Yoshinori Kushiyama ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Efficacy ◽  
Activity Index ◽  
Fecal Calprotectin ◽  
Mucosal Healing ◽  
Time Dependent ◽  
Clinical Activity ◽  
Active Ulcerative Colitis ◽  
Release Formulation ◽  
Ph Dependent

Purpose. Few reports have compared the clinical efficacy of a pH-dependent release formulation of mesalazine (pH-5-ASA) with a time-dependent release formulation (time-5-ASA). We examined whether pH-5-ASA is effective for active ulcerative colitis (UC) in patients resistant to time-5-ASA.Methods. We retrospectively and prospectively analyzed the efficacy of pH-5-ASA in mildly to moderately active UC patients in whom time-5-ASA did not successfully induce or maintain remission. The clinical efficacy of pH-5-ASA was assessed by clinical activity index (CAI) before and after switching from time-5-ASA. In addition, the efficacy of pH-5-ASA on mucosal healing (MH) was evaluated in a prospective manner by measuring fecal calprotectin concentration.Results. Thirty patients were analyzed in a retrospective manner. CAI was significantly reduced at both 4 and 8 weeks after switching to pH-5-ASA. In the prospective study (n=14), administration of pH-5-ASA also significantly reduced CAI scores at 4 and 8 weeks in these patients who were resistant to time-5-ASA. In addition, fecal calprotectin concentration was significantly decreased along with improvement in CAI after switching to pH-5-ASA.Conclusions. Our results suggest that pH-5-ASA has clinical efficacy for mildly to moderately active patients with UC in whom time-5-ASA did not successfully induce or maintain remission.

scholarly journals P187 The significance of netrin-1 level in the clinical activity of ulcerative colitis, its association between TNF-α and IL-6

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S232-S232
Author(s):  
H Korkmaz ◽  
K Fidan
Keyword(s):  
Ulcerative Colitis ◽  
Proinflammatory Cytokines ◽  
Activity Index ◽  
Enzyme Linked Immunosorbent Assay ◽  
Control Group ◽  
Clinical Activity ◽  
Tnf Α ◽  
Significant Difference ◽  
And Control ◽  
Control Study

Abstract Background In this study, we investigated the importance of netrin-1 levels in ulcerative colitis (UC) in clinical activity of the disease, and its association with other proinflammatory cytokines IL-6 and TNF-α. Methods This study is a type of case–control study. Sixty-seven patients with UC (36 of them activation, 31 of remission) and 50 healthy controls were included in the study. UC patients; ‘Truelove Witts clinical activity index by remission (n = 31), mild activation (n = 21), moderate activation (n = 6) and severe activation (n = 9) were divided into groups. Netrin, IL-6 and TNF-α measurements in plasma samples were performed using enzyme-linked immunosorbent assay kit. Results Between the patient group and the control group; there was a statistically significant difference between netrin-1, IL-6, TNF-α, neutrophil, platelet (p < 0.05 for all). The plasma netrin-1 mean of UC with severe activation group (139.21 ± 48.09 pg/ml) was statistically significantly higher than that of the mild activation (p = 0,037), remission group (p = 0,001) and control group(p = 0,011). The plasma netrin-1 mean of UC with moderate activation group was statistically significantly higher than that of the mild activation(p = 0,045) and remission group(p = 0,004). Conclusion Our results reveal that plasma netrin-1 levels have been shown to be associated with UC activation, similar to proinflammatory cytokines such as TNF-α and IL-6, in UC.

scholarly journals P489 Rescue treatment with original versus biosimilar infliximab in biologic-naïve patients with moderate-severe Ulcerative Colitis and corticosteroid failure

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S475-S475
Author(s):  
C Muñoz-Villafranca ◽  
M Á Ogueta ◽  
P Ramírez de la Piscina ◽  
B Álvarez-Herrero ◽  
A Loizate ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Colonic Mucosa ◽  
Rescue Therapy ◽  
Basque Country ◽  
Clinical Activity ◽  
Severe Ulcerative Colitis ◽  
Mayo Score ◽  
Rescue Treatment ◽  
Significant Difference ◽  
One Year

Abstract Background Infliximab is effective as rescue therapy in moderate-severe Ulcerative Colitis (UC). Subsequently, a biosimilar of infliximab has been approved for the same indications, as its effectiveness is considered similar to the original infliximab. Our aim was to analyse the colectomy rate and the efficacy of original infliximab (Remicade®) versus biosimilar infliximab (Inflectra®) in patients with moderate-severe UC who failed to respond to intravenous corticosteroids. Methods We performed a retrospective and observational study in two hospitals in the Basque Country. All patients hospitalised between 2010–2020 with moderate-severe UC, without response to intravenous corticosteroids and rescue treatment with infliximab were consecutively included. Two cohorts were established: the first one from 2010 to 2015 in patients treated with Remicade®, and the second one from 2015 to 2020 in patients with Inflectra®. We assessed all patients that had received at least one dose of infliximab. Patients were followed for a period of one year until loss of response or colectomy. Early colectomy is the surgery performed until week 12, and late colectomy between week 12 and one year. At the moment of hospitalisation all patients were clinically and endoscopically evaluated by Mayo Score. The clinical response was assessed in week 14 and 52. Results A total of 85 patients were evaluated, 53 (64.4%) in Remicade® group and 32 (37.6%) in Inflectra® group. 21.17% (18/85) of the patients had a colectomy in one year. 77.7% of the colectomies took place in the first 12 weeks (14/18, 7 patient in each group). Rates of early (13.8% vs 21.9%, p=0.297) and late colectomy (17% vs 28.1%, p=0.223) showed a numerical but non-statistically significant difference in favour of Remicade®. Transfusion (OR=4.20, IC 95% [1.38–12.77], p=0.011) and the presence of cytomegalovirus in the colonic mucosa (OR=4.07, IC 95% [1.31–12.63], p=0.015) were univariate predictors of colectomy. A statistically significant difference was found in clinical remission at week 14 (49.1% vs 25%, p=0.040) but not at week 52 (73.7% vs 50%, p=0.074) in patients with Remicade® versus Inflectra®. Neither clinical activity nor mucosa activity showed relationship with risk of colectomy. Conclusion 1. The rescue therapy with infliximab in patients with moderate-severe Ulcerative Colitis who failed to respond to intravenous corticosteroids could show a favourable trend for Remicade® against Inflectra®. However, further research is needed to confirm it. 2. The need of transfusion and the presence of cytomegalovirus in the colonic mucosa could be predictive factors of colectomy.

scholarly journals Endoscopic score vs blood cell indices for determining timing of immunomodulator withdrawal in quiescent ulcerative colitis

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Kazuhiro Takenaka ◽  
Keiichi Tominaga ◽  
Mimari Kanazawa ◽  
Koh Fukushi ◽  
Takanao Tanaka ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Blood Cell ◽  
Activity Index ◽  
Mucosal Healing ◽  
Clinical Activity ◽  
Monitoring Methods ◽  
Mean Cell Volume ◽  
Remission Maintenance ◽  
Significant Difference ◽  
Activity Index Score

AbstractWhile immunomodulators (IMs) are used as key drugs in remission maintenance treatment for ulcerative colitis (UC), there has been no evidence to date for determining monitoring methods and drug withdrawal. Therefore, we examined if a decrease in white blood cell count (WBC) and an elevation in mean cell volume (MCV) could be used as optimization indices and if mucosal healing (MH) could be a rationale for determining the time of IM withdrawal. Subjects were 89 UC patients who were using IMs and for whom clinical remission had been maintained. Those with a Rachmilewitz Clinical Activity Index score of 4 or lower and those with a Mayo endoscopic subscore (MES) of 0 or 1 were defined as MH. The remission maintenance rates of the following comparative groups were examined: an IM continuation group and an IM withdrawal group; an IM continuation group with a WBC of less than 3000 or a MCV of 100 or greater and an IM continuation group with a WBC of 3000 or greater and a MCV of 99 or lower; an IM continuation group of patients for whom MH had been achieved and an IM continuation group of patients for whom MH had not been achieved; and an IM withdrawal group with a MES of 0 and an IM withdrawal group with a MES of 1. A significantly higher remission maintenance rate was observed in the IM continuation group compared to the withdrawal group (p < 0.01). No significant difference was observed between the IM continuation group with a WBC of less than 3000 or a MCV of 100 or greater and the IM continuation group with a WBC of 3000 or greater and a MCV of 99 or lower (p = 0.08). Higher remission maintenance rates were observed in the IM continuation group of patients for whom MH had been achieved compared to the IM continuation group of patients for whom MH had not been achieved (p = 0.03). No significant difference was observed between the IM withdrawal group with MES 0 and the IM withdrawal group with MES 1. (p = 0.48). This retrospective study showed that remission maintenance could be firmly obtained by continuing IM administration in case of endoscopic MH; however, MH was not an indicator of IM withdrawal.

scholarly journals A Phase 2a, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial of IBD98-M Delayed-Release Capsules to Induce Remission in Patients with Active and Mild to Moderate Ulcerative Colitis

Cells ◽  
2019 ◽  
Vol 8 (6) ◽  
pp. 523 ◽  
Author(s):  
Gionata Fiorino ◽  
Giacomo Carlo Sturniolo ◽  
Fabrizio Bossa ◽  
Andrea Cassinotti ◽  
Antonio Di Sabatino ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Response ◽  
Activity Index ◽  
Controlled Trial ◽  
Disease Activity Index ◽  
Fecal Calprotectin ◽  
Summary Score ◽  
Double Blind ◽  
Release Formulation ◽  
Delayed Release

IBD98-M is a delayed-release formulation of mesalamine (mesalazine) and SH with a potential therapeutic role in ulcerative colitis (UC). A total of 51 patients with a modified Ulcerative Colitis Disease Activity Index (UCDAI) score of ≥4 and ≤10, and a modified UCDAI endoscopy subscore ≥1 were randomized for 6 weeks of double-blind treatment with IBD98 0.8 g/day or IBD 1.2 g/day or placebo. The efficacy and safety of IBD98-M in mild to moderate active UC were primarily evaluated. At week 6, 1 (5.9%), 2 (12.5%), and 2 (11.1%) patients receiving IBD98-M 0.8 g, IBD98-M 1.2 g, and placebo, respectively, (p > 0.999) achieved clinical remission. Higher clinical response was seen in IBD98-M 1.2 g (31.3%) versus placebo (16.7%) and endoscopic improvement in IBD98-M 0.8 g (29.4%) versus placebo (22.2%) was seen. Fecal calprotectin levels were reduced in IBD98-M groups versus placebo (p > 0.05). IBD98-M patients achieved significant improvement in physical health summary score component of the SF-36 (p = 0.01 and p = 0.03 respectively) compared to placebo. IBD98-M did not meet the primary end point but had higher clinical response (1.2 g/day) and endoscopic improvement (0.8 g/day) compared to placebo. The safety result shown that IBD98-M treatment was safe and well tolerated in this patient population. No new safety signals or unexpected safety findings were observed during the study. Further trials with different stratification and longer follow-up may be needed to evaluate the efficacy.

scholarly journals Sa1211 Fecal Hemoglobin As a Marker for Mucosal Inflammation of Ulcerative Colitis: Usefulness of Combination With Rachmilewitz's Clinical Activity Index

2014 ◽  
Vol 146 (5) ◽  
pp. S-231
Author(s):  
Shigeru Kanaoka ◽  
Shigeru Kuriyama ◽  
Moriya Iwaizumi ◽  
Takanori Yamada ◽  
Mitsushige Sugimoto ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Activity Index ◽  
Mucosal Inflammation ◽  
Clinical Activity

scholarly journals The Th17/Treg Immune Imbalance in Ulcerative Colitis Disease in a Chinese Han Population

2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Yang Gong ◽  
Yifan Lin ◽  
Ning Zhao ◽  
Xiaojuan He ◽  
Aiping Lu ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Healthy Subjects ◽  
Activity Index ◽  
Treg Cells ◽  
Clinical Activity ◽  
Endoscopic Evaluation ◽  
Chinese Han ◽  
Han Population ◽  
Immune Balance ◽  
Immune Imbalance

Objective. To investigate the Th17/Treg immune balance in the ulcerative colitis (UC) patients in a Chinese Han population. Methods. Ninety UC patients and 30 healthy subjects were enrolled. The serum IL-17 and TGF-β1 levels of these participants were measured with ELISA; the percentage of Th17 and Treg cells in peripheral blood was determined with flow cytometry. Results. In UC patients, the levels of IL-17 and Th17 were significantly higher compared with healthy subjects; the percentage of Th17 and IL-17 level in moderate and severe subgroup was significantly higher than in mild subgroup; a positive correlation existed between these two indexes and clinical activity index and endoscopic evaluation. TGF-β1 level and Treg cells in UC patients were lower than healthy subjects. TGF-β1 level in moderate and severe subgroup was lower than in mild subgroup. There was a negative linear correlation between Treg cells and clinical activity index, endoscopic evaluation. A positive correlation was detected between Treg cells and TGF-β1 level. Conclusions. Th17/Treg immune imbalance might play a crucial role in the development of UC. To induce the production of Treg cells and TGF-β1, inhibit the level of Th17 and IL-17, and thus recover the Th17/Treg immune balance might imply new therapeutic targets in UC management.

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