scholarly journals P480. Efficacy of switching to pH-dependent release formulation of mesalazine at 3.6 g/day from time-dependent release formulation of mesalazine at 4.0 g/day in patients with Ulcerative Colitis

2015 ◽  
Vol 9 (suppl 1) ◽  
pp. S319-S320 ◽  
Keyword(s):  
Ulcerative Colitis ◽  
Time Dependent ◽  
Release Formulation ◽  
Ph Dependent

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 P630 Complete endoscopic remission is not only associated with higher mucosal concentrations of 5-aminosalicylic acid but also with N-acetyl-5-aminosalicylic acid in patients with ulcerative colitis

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S522-S523
Author(s):  
T Fukuda ◽  
M Naganuma ◽  
K Takabayashi ◽  
Y Hagihara ◽  
S Tanemoto ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Sigmoid Colon ◽  
Cross Sectional Study ◽  
Time Dependent ◽  
Aminosalicylic Acid ◽  
Cross Sectional ◽  
Endoscopic Remission ◽  
Ph Dependent ◽  
The Difference ◽  
Pre Treatment

Abstract Background The mechanisms behind 5-aminosalicylic acid (5-ASA) activity in ulcerative colitis (UC) are known to exert a beneficial effect by acting topically on colonic mucosa. this study investigated whether mucosal 5-ASA and N-acetyl-5-ASA (Ac-5-ASA) concentrations are associated with endoscopic remission. Methods This single-centre, prospective cross-sectional study was conducted between March 2018 and February 2019. Patients with UC who were treated with 5-ASA medications for at least 8 weeks prior to sigmoidoscopy were enrolled. All participants underwent sigmoidoscopy without pre-treatment, and biopsies were performed to extract approximately 10 mg of tissue from the sigmoid colon and rectum. Mucosal concentrations of 5-ASA and Ac-5-ASA were measured using liquid chromatography with tandem mass spectrometry. The main endpoint was defined as the difference in mucosal concentrations of 5-ASA and Ac-5-ASA according to the level of either the Mayo endoscopic subscore (MES) or the ulcerative colitis Endoscopic Index of Severity (UCEIS). Results Mucosal concentrations were analysed in 50 patients. In the sigmoid colon, the median 5-ASA concentration in patients with MES of 0 (17.3 ng/mg) was significantly higher than MES ≥1 (6.4 ng/mg) (p = 0.019). The median 5-ASA concentration in patients with UCEIS ≤1 (16.4 ng/mg) was also significantly higher than in patients with UCEIS ≥2 (4.63 ng/mg) (p = 0.047). Interestingly, the concentration of Ac-5-ASA was higher in patients with an MES of 0 (21.2 ng/mg) than in patients with an MES≥1 (5.81 ng/mg) (p = 0.022). Similarly, the Ac-5-ASA concentration was significantly higher in patients with a UCEIS≤1 (21.1 ng/mg) compared with that in patients with a UCEIS≥2 (7.8 ng/mg) (p = 0.048). Furthermore, we compared the concentrations of 5-ASA in patients receiving the maximum dose of the three different formulations (time-dependent, pH-dependent, or multimatrix system 5-ASA). 5-ASA concentrations in both sigmoid colon and the rectum tended to be lower in patients receiving time-dependent 5-ASA than patients receiving pH-dependent 5-ASA or multimatrix system 5-ASA, but the difference was not significant. Conclusion Although Ac-5ASA, a metabolite of 5-ASA is thought to have few pharmacological effect, this study demonstrated that patients with complete endoscopic remission had higher mucosal concentrations of not only 5-ASA but also Ac-5-ASA than patients with mild-to-moderate endoscopic severity. This result may be explained by the fact that Ac-5-ASA remains as a metabolite of 5-ASA after contributing to the suppression of inflammation in patients with endoscopic remission.

scholarly journals Optimization study of combined enteric and time-dependent polymethacrylates as a coating for colon targeted delivery of 5-ASA pellets in rats with ulcerative colitis

2021 ◽  
pp. 106072
Author(s):  
Hossein Shahdadi Sardou ◽  
Abbas Akhgari ◽  
Amir Hooshang Mohammadpour ◽  
Ali Beheshti Namdar ◽  
Hossein Kamali ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Targeted Delivery ◽  
Time Dependent ◽  
Optimization Study

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.

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