scholarly journals Effectiveness of treatment of moderate ulcerative colitis with prolonged mesalazine in real clinical practice

2021 ◽  
pp. 144-151
Author(s):  
O. V. Knyazev ◽  
A. V. Kagramanova ◽  
A. A. Lishchinskaya
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Topical Therapy ◽  
Fecal Calprotectin ◽  
Mucosal Healing ◽  
Prolonged Release ◽  
Mayo Score ◽  
Endoscopic Remission ◽  
Oral Mesalazine ◽  
High Doses

Introduction. Ulcerative colitis (UC) is one of the severe therapeutic diseases. High doses of oral granular mesalazine are required to maintain clinical and endoscopic remission of UC, which may be sufficient and supposedly more acceptable for patients, as some studies showed that adherence to topical therapy is significantly lower than to oral 5-ASA drugs.Objective of the study. To evaluate the efficacy of therapy of patients with moderate left-sided ulcerative colitis (UC) and pancolitis receiving prolonged-release ethylcellulose-coated mesalazine.Materials and methods. The evaluation of the outcomes of treatment of UC patients who received prolonged-release mesalazine was carried out. We examined 87 patients with UC who received granular ethylcellulose-coated mesalazine, of those 38 (43.7%) men and 49 (56.3%) women. The average age of the enrolled patients was 38.3 ± 12.6 years.Results and discussion. After 2 weeks from the beginning of therapy with prolonged-release mesalazine, the majority of patients – 71 (81.6%) responded to the therapy. After 12 weeks, 71 (81.6%) of 87 UC patients, who responded to therapy with prolongedrelease mesalazine, remained in clinical remission. On average, the Mayo score in the group decreased from 7.6 ± 0.99 to 2.6 ± 0.25 points. There was a significant decrease in CRP, ESR, leukocytosis, and fecal calprotectin. After 26 weeks, Mayo score in the group of patients remained on average at the level of 2.2–2.3 points. The number of UC patients with colon mucosal healing was 32 (36.8%) patients. A year after the start of therapy with prolonged-release mesalazine, 69 (79.3%) UC patients who responded to therapy had a clinical remission, of those 32 (36.8%) patients had a clinical and endoscopic remission. During the year of observation, no case of surgical intervention or re-hospitalization due to exacerbation of the disease was recorded in patients with UC who achieved remission.Conclusions. Treatment of moderate active UC should begin with oral mesalazine ≥ 3 g per day in combination with topical mesalazine. The prolonged-release mesalazines are the most preferred

scholarly journals Effectiveness of treatment moderate ulcerative colitis with prolonged-release ethylcellulose-coated mesalazine in real clinical practice in Moscow

2021 ◽  
Vol 2 (2) ◽  
pp. 65-74
Author(s):  
Oleg V. Knyazev ◽  
Аnna V. Kagramanova ◽  
Alexey V. Veselov ◽  
Tatyana V. Skurko
Keyword(s):  
Ulcerative Colitis ◽  
Fecal Calprotectin ◽  
Response To Therapy ◽  
Prolonged Release ◽  
Inflammation Markers ◽  
Results Of Treatment ◽  
Mayo Score ◽  
Endoscopic Remission ◽  
Oral Mesalazine

Background and purpose. The aim of this work is to evaluate the efficacy of treatment patients with moderate left-sided and total ulcerative colitis (UC) with prolonged-release ethylcellulose-coated mesalazine. Materials and methods. The clinical analyses of results of treatment UC patients with prolonged-release ethylcellulose-coated mesalazine was performed. Eighty-seven patients with UC, treated with ethylcellulose coated microgranules of mesalazine, were examined: 38 (43,7%) men and 49 (56,3%) women. The age of patients was from 26 to 49 years, median age 38,3±12,6 year. Results. After 2 weeks prolonged-release ethylcellulose coated mesalazine treatment the response to therapy was demonstrated in majority of UC patients -71 (81,6%). After 12 weeks treatment prolonged remission persisted in 71 (81,6%) UC patients. Mayo score decreased from 7,6±0,99 to 2,6±0,25 points. Significant decrease of inflammation markers (CRP, ESR, leukocytosis, fecal calprotectin etc) was determined. After 26 weeks of treatment Mayo score was 2,2-2,3 points. Thirty-two (36,8%) UC patients showed healing of colon mucosa. After 1 year of prolonged-release ethylcellulose-coated mesalazine treatment clinical remission was determined in 69 (79,3%) UC patients with response to therapy, clinical-endoscopic remission — in 32 (36,8%) patients. During 1 year follow-up no cases of surgical procedure and readmission because of UC reccurence were noted. Conclusion. Treatment of moderate active UC should be started with oral mesalazine > 3 gr per day and rectal mesalazine. The most appropriate effective and high compliance forms of mesalazine are prolonged-release forms of meselazine.

scholarly journals MODERATE TO SEVERE ENDOSCOPIC INFLAMMATION IS FREQUENT AFTER ACHIEVING CLINICAL REMISSION IN PEDIATRIC ULCERATIVE COLITIS

2021 ◽  
Vol 27 (Supplement_1) ◽  
pp. S13-S13
Author(s):  
Chen Sarbagili-Shabat ◽  
Dror Weiner ◽  
Joram Wardi ◽  
Lee Abramas ◽  
Michal Yaakov ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Residual Disease ◽  
Activity Index ◽  
Final Analysis ◽  
Mucosal Healing ◽  
Sustained Remission ◽  
High Relapse Rate ◽  
Mayo Score

Abstract Background Pediatric ulcerative colitis (UC) is characterized by low sustained remission rates and frequent extension of disease even if clinical remission is obtained with therapy. Moderate to severe endoscopic activity is a risk factor for relapse while evidence regarding early mucosal healing or persistence of inflammation after remission in children is not available. Our aim was to evaluate if persistence of significant inflammation is common and could explain the high relapse rate in pediatric UC. Methods Pediatric UC patients with clinical remission, defined as pediatric UC activity index (PUCAI) scores < 10, were prospectively assessed for mucosal healing by endoscopy 3–5 months after remission was documented. Mayo score was assessed for each segment by a blinded adult gastroenterologist using central reading. Symptomatic patients prior to sigmoidoscopy were excluded Sustained remission was assessed retrospectively at 18 months follow-up. Results Forty-six children were enrolled, 28 children in continuous clinical remission at time of sigmoidoscopy were included in the final analysis. Mayo 0 was present in 12/28 (42.86%), Mayo 1 in 2/28 (7.1%) and Mayo 2–3 in 14/28 (50.0%) endoscopies. Among 23/28 patients with follow-up through 18 months, remission was sustained in 2/11 (18.18%) of patients with Mayo 2 and 3 versus 6/12 (50.0%) with Mayo score 0–1. Conclusion Over 50% of children assessed for mucosal healing 3–5 months after clinical remission is obtained have residual disease activity, primarily moderate to severe inflammation which was associated with lower sustained remission. Early sigmoidoscopy after clinical remission for assessment of mucosal disease should be considered in pediatric UC.

scholarly journals OP24 Efficacy and safety of upadacitinib induction therapy in patients with Moderately to Severely Active Ulcerative Colitis: Results from the phase 3 U-ACHIEVE study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S022-S024
Author(s):  
S Danese ◽  
S Vermeire ◽  
W Zhou ◽  
A Pangan ◽  
J Siffledeen ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Response ◽  
Induction Therapy ◽  
Clinical Remission ◽  
Janus Kinase ◽  
Phase 3 ◽  
Mayo Score ◽  
Significant Difference ◽  
Endoscopic Remission ◽  
Secondary Endpoints

Abstract Background An unmet therapeutic need remains in patients with ulcerative colitis (UC). U-ACHIEVE is one of two phase 3 induction trials evaluating the safety and efficacy of the selective Janus kinase–1 inhibitor upadacitinib (UPA) 45 mg once daily (QD) in adults with UC. Methods U-ACHIEVE is a multicentre, double-blind, placebo (PBO)–controlled trial (NCT02819635) that randomized patients with moderately to severely active UC 2:1 to UPA 45 mg QD or PBO for 8 weeks. Patients were stratified by response to biologic therapy (inadequate vs non–inadequate responder), baseline corticosteroid use (yes or no), and baseline adapted Mayo score (≤7 or >7). The primary endpoint was proportion of patients achieving clinical remission (per adapted Mayo Score) at week 8.Ranked secondary endpoints included endoscopic improvement, endoscopic remission, and clinical response per adapted Mayo Score at week 8; clinical response per partial adapted Mayo Score at week 2; and histologic-endoscopic mucosal improvement at week 8. Non-responder imputation incorporating multiple imputations for missing data due to COVID-19 are reported. Safety was assessed through week 8. Results 474 patients were randomized (UPA, n=319; PBO, n=155). Baseline characteristics were well balanced between groups (Table 1). A significantly higher proportion of patients receiving UPA (26.1%) vs PBO (4.8%) achieved clinical remission at week 8 (adjusted treatment difference [95% CI], 21.6% [15.8, 27.4]; P<0.001; Figure 1). For all ranked secondary endpoints, UPA was superior to PBO (P<0.001; Figure 1). A significant difference in clinical response favouring UPA vs PBO was seen as early as week 2 (60.1% vs 27.3%) and was sustained over 8 weeks (79.0% vs 41.6%; Figure 2). There were more serious adverse events (AEs), severe AEs, and AEs leading to study drug discontinuation with PBO (Table 2). The most common AEs were acne, creatine phosphokinase elevation, and nasopharyngitis with UPA and worsening of UC and anaemia with PBO. Incidence of serious infection was similar between UPA and PBO. Neutropenia and lymphopenia were reported more frequently with UPA vs PBO (Table 2).No adjudicated gastrointestinal perforation, major cardiovascular AEs, or thrombotic events and no active tuberculosis, malignancy, or deaths were reported. Conclusion In patients with moderately to severely active UC, UPA 45 mg QD induction therapy was superior to PBO in inducing clinical remission/response, and endoscopic remission/response over 8 weeks; responses were significant and rapid. UPA 45 mg QD was well tolerated; safety was comparable with the known safety profile of UPA, and no new safety signals were identified.

scholarly journals Long-term, Real-life, Observational Study in Treating Outpatient Ulcerative Colitis with Golimumab

2021 ◽  
Author(s):  
Antonio Tursi ◽  
Giammarco Mocci ◽  
Walter Elisei ◽  
Leonardo Allegretta ◽  
Raffaele Colucci ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Response ◽  
Clinical Remission ◽  
Real Life ◽  
Mucosal Healing ◽  
Term Treatment ◽  
Short Term Treatment ◽  
Mayo Score

Background and Aims: Several studies have found Golimumab (GOL) effective and safe in the short-term treatment of ulcerative colitis (UC), but few long-term data are currently available from real world. Our aim was to assess the long-term real-life efficacy and safety of GOL in managing UC outpatients in Italy. Methods: A retrospective multicenter study assessing consecutive UC outpatients treated with GOL for at least 3-month of follow-up was made. Primary endpoints were the induction and maintenance of remission in UC, defined as Mayo score ≤2. Several secondary endpoints, including clinical response, colectomy rate, steroid free remission and mucosal healing, were also assessed during the follow-up. Results: One hundred and seventy-eight patients were enrolled and followed up for a median (IQR) time of 9 (3-18) months (mean time follow-up: 33.1±13 months). Clinical remission was achieved in 57 (32.1%) patients: these patients continued with GOL, but only 6 patients (3.4%) were still under clinical remission with GOL at the 42nd month of follow-up. Clinical response occurred in 64 (36.4%) patients; colectomy was performed in 8 (7.8%) patients, all of them having primary failure. Steroid-free remission occurred in 23 (12.9%) patients, and mucosal healing was achieved in 29/89 (32.6%) patients. Adverse events occurred in 14 (7.9%) patients. Conclusions: Golimumab does not seem able to maintain long-term remission in UC in real life. The safety profile was good.

Novel Prognostic Biomarkers of Mucosal Healing in Ulcerative Colitis Patients Treated With Anti-TNF: Neutrophil-to-Lymphocyte Ratio and Platelet-to-Lymphocyte Ratio

2020 ◽  
Vol 26 (10) ◽  
pp. 1579-1587 ◽  
Author(s):  
Lorenzo Bertani ◽  
Federico Rossari ◽  
Brigida Barberio ◽  
Maria Giulia Demarzo ◽  
Gherardo Tapete ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Corticosteroid Treatment ◽  
Fecal Calprotectin ◽  
Mucosal Healing ◽  
Neutrophil To Lymphocyte Ratio ◽  
First Year ◽  
Platelet To Lymphocyte Ratio ◽  
Lymphocyte Ratio ◽  
Early Predictors

Abstract Background Anti-tumor necrosis factor drugs (anti-TNFs) are widely used for the treatment of ulcerative colitis (UC). However, many patients experience loss of response during the first year of therapy. An early predictor of clinical remission and mucosal healing is needed. The neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) are markers of subclinical inflammation poorly evaluated in UC patients treated with anti-TNFs. The aim of this multicenter study was to evaluate whether NLR and PLR could be used as prognostic markers of anti-TNF treatment response. Methods Patients with UC who started anti-TNF treatment in monotherapy were evaluated. Patients with concomitant corticosteroid treatment ≥20 mg were excluded. We calculated NLR, PLR, and fecal calprotectin before treatment and after induction. The values of NLR and PLR were correlated with clinical remission and mucosal healing at the end of follow-up (54 weeks) using the Mann-Whitney U test and then multivariate analysis was conducted. Results Eighty-eight patients were included. Patients who reached mucosal healing after 54 weeks of therapy displayed lower levels of both baseline NLR and PLR (P = 0.0001 and P = 0.04, respectively); similar results were obtained at week 8 (P = 0.0001 and P = 0.001, respectively). Patients who presented with active ulcers at baseline endoscopic evaluation had higher baseline NLR and PLR values compared with those without detected ulcers (P = 0.002 and P = 0.0007, respectively). Conclusions BothNLR and PLR showed a promising role as early predictors of therapeutic response to anti-TNF therapy in UC patients. If confirmed in larger studies, classification and regression trees proposed in this article could be useful to guide clinical decisions regarding anti-TNF treatment.

Sa1876 LOW FECAL CALPROTECTIN LEVEL PREDICTS HISTOLOGICAL HEALING AND PROLONGED CLINICAL REMISSION IN ULCERATIVE COLITIS PATIENTS WITH CLINICAL REMISSION AND MUCOSAL HEALING

2020 ◽  
Vol 158 (6) ◽  
pp. S-461-S-462
Author(s):  
Kousaku Kawashima ◽  
Naoki Oshima ◽  
Takafumi Yuki ◽  
Satoshi Kotani ◽  
Hiroki Sonoyama ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Fecal Calprotectin ◽  
Mucosal Healing ◽  
Calprotectin Level

scholarly journals P215 Endoscopic remission (Mayo score 0 rather than score 1) predicts long-term clinical remission in ulcerative colitis

2013 ◽  
Vol 7 ◽  
pp. S95 ◽  
Author(s):  
N. Inoue ◽  
K. Takabayashi ◽  
T. Takayama ◽  
K. Matsuoka ◽  
M. Naganuma ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Mayo Score ◽  
Endoscopic Remission

scholarly journals P148 Reproducibility of PICaSSO score by using narrow banding images (NBI) to assess mucosal and histological healing in ulcerative colitis (UC) patients

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S211-S212 ◽  
Author(s):  
R Cannatelli ◽  
O Nardone ◽  
U Shivaji ◽  
S C L Smith ◽  
A Bazarova ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Roc Curves ◽  
Mucosal Healing ◽  
Operating Characteristics ◽  
Mayo Score ◽  
Endoscopic Remission ◽  
Histological Activity ◽  
Index Of Severity ◽  
Virtual Chromoendoscopy ◽  
Sensitivity Specificity

Abstract Background The endoscopic and histological healing are key therapeutic targets in ulcerative colitis(UC) patients. PICaSSO (Paddington International virtual ChromoendoScopy ScOre)1,2 is a new Virtual Chromoendoscopy Endoscopic (VCE) score to better define mucosal healing by mucosal and vascular features. Originally validated using iSCAN platform, the aim of this study was to evaluate the reproducibility of PICaSSO with NBI near focus platform and to assess if this could predict histological healing. Methods We prospectively studied 78 UC patients (mean age 43.4 years, 52.6% male) who underwent colonoscopy for colitis assessment or surveillance using NBI near focus (Olympus, Japan). Endoscopic activity was assessed by using ulcerative colitis Endoscopic Index of Severity (UCEIS) and PICaSSO; whilst histological activity was scored by the Robarts Histology Index (RHI). ROC curves were performed to evaluate sensitivity, specificity and accuracy of endoscopy scores to predict histological healing. Results Out of 78 patients, 47 (60.3%) were in clinical remission according to the partial Mayo score. 28(35.9%) and 32(41.0%) were in endoscopic remission according to UCEIS≤1 and PICaSSO≤3, respectively. The best cut-off of UCEIS to predict histological healing was less or equal to 1. Sensitivity, specificity and accuracy were 84.6% (95% CI 63.5, 96.4), 88.5% (95% CI 70.1, 97.8) and 87.2% (95% CI 75.6, 93.6), respectively. The Area Under the ROC curve (AUROC) was 93.3% (95% CI 88.2, 98.3). The best threshold of PICaSSO in the prediction of histological healing was less or equal to 3. PICaSSO ≤ 3 have sensitivity of 96.2% (95% CI 76.9, 100), specificity of 86.5% (95% CI 67.3, 96.2) and accuracy of 89.7% (95% CI 77.6, 96.2) to predict histological healing, estimated as RHI ≤ 3. The AUROC was 95.3% (95% CI 91.1, 99.5). Conclusion PICaSSO VCE score can be easily and accurately reproduced with NBI near focus platform and it has better operating characteristics than UCEIS to predict histological healing defined by RHI. Reference

Fecal Calprotectin Thresholds to Predict Endoscopic Remission Using Advanced Optical Enhancement Techniques and Histological Remission in IBD Patients

2020 ◽  
Author(s):  
Rosanna Cannatelli ◽  
Alina Bazarova ◽  
Davide Zardo ◽  
Olga Maria Nardone ◽  
Uday Shivaji ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Surrogate Marker ◽  
Fecal Calprotectin ◽  
Cross Sectional Study ◽  
Mucosal Healing ◽  
Cross Sectional ◽  
Endoscopic Techniques ◽  
Endoscopic Remission ◽  
Endoscopic Score ◽  
Histological Remission

Abstract Background Fecal calprotectin (FC) is a common surrogate marker of mucosal healing (MH) in patients with ulcerative colitis (UC) and Crohn’s disease (CD). We investigated the optimum FC thresholds for defining endoscopic remission (ER) and histological remission (HR) using advanced endoscopic techniques. Patients and Methods In this cross-sectional study, we collected clinical, endoscopic, histological data, and FC from 76 UC and 41 CD patients. Receiver operating characteristic curves were created to evaluate the optimum cut-off of FC to predict ER evaluated by Mayo Endoscopic Score (MES), Ulcerative Colitis Endoscopic Index of Severity (UCEIS), and modified PICaSSO (Paddington International Virtual Chromoendoscopy Score) for UC patients and Simple Endoscopic Score (SES-CD) in CD patients; and HR was scored by the Robarts Histology Index (RHI) and Nancy Index for UC and modified Riley for CD. Results In UC patients, the best thresholds of FC to identify ER calculated with MES, UCEIS, and modified PICaSSO were 112, 148, and 161 mcg/g with accuracy of 86.9% 86.8%, and 81.6%, respectively. The best value of FC to predict HR was 112 mcg/g and 172 mcg/g with accuracy of 84.2% and 81.6% for RHI and Nancy Index, respectively. In CD patients, the best cut-off of FC to predict ER was 96 mcg/g with accuracy of 82.9%. The HR was best predicted by an FC value of 225 mcg/g with accuracy of 75.6%. Conclusions The FC value threshold between 112 and 172 mcg/g could identify ER and HR in UC patients, whereas a value under 225 mcg/g should be considered for CD patients.

Role of Faecal Microbiota Transplantation for Maintenance of Remission in Patients With Ulcerative Colitis: A Pilot Study

2019 ◽  
Vol 13 (10) ◽  
pp. 1311-1317 ◽  
Author(s):  
Ajit Sood ◽  
Ramit Mahajan ◽  
Arshdeep Singh ◽  
Vandana Midha ◽  
Varun Mehta ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Pilot Study ◽  
Clinical Remission ◽  
Faecal Microbiota ◽  
Mayo Score ◽  
Endoscopic Remission ◽  
Secondary Endpoints ◽  
Maintenance Of Remission ◽  
Histological Remission

Abstract Objectives To study the role of faecal microbiota transplantation [FMT] in maintenance of remission in ulcerative colitis [UC]. Methods In this pilot study, patients with UC in clinical remission achieved after multi-session FMT were randomly allocated to either maintenance FMT or placebo colonoscopic infusion every 8 weeks, for 48 weeks. The standard of care [SOC] therapy was continued in all patients. The primary endpoint was maintenance of steroid-free clinical remission [Mayo score ≤2, all subscores ≤1] at Week 48. Secondary endpoints were achievement of endoscopic remission [endoscopic Mayo score 0] and histological remission [Nancy grade 0, 1] at Week 48. Results In all, 61 patients in clinical remission were randomised to receive either FMT [n = 31] or placebo [n = 30]. The primary outcome was achieved in 27/31 [87.1%] patients allocated FMT versus 20/30 [66.7%] patients assigned placebo [p = 0.111]. Secondary endpoints of endoscopic remission (FMT: 18/31 [58.1%] versus placebo: 8/30 [26.7%], p = 0.026) and histological remission (FMT: 14/31 [45.2%] versus placebo: 5/30 [16.7%], p = 0. 033) were achieved in a significantly higher number of patients with FMT. Three patients receiving FMT [9.7%] and 8 patients on placebo [26.7%] relapsed. There were no serious adverse events necessitating discontinuation in patients on FMT; one patient who relapsed on placebo required colectomy. Conclusions Maintenance FMT in patients who are in clinical remission may help sustain clinical, endoscopic and histological remission in patients with UC.

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