scholarly journals Evaluation of the efficacy of MMX mesalazine therapy for moderate ulcerative colitis

2021 ◽  
pp. 113-123
Author(s):  
O. V. Knyazev ◽  
A. V. Kagramanova ◽  
A. A. Lishchinskaya

Introduction. Treatment of patients with ulcerative colitis (UC) requires continuous anti-relapse therapy. Mesalazines are the firstline disease-modifying drugs for the treatment of mild to moderate UC to manage exacerbations and to induce and maintain remission.This paper is aimed at comparing the efficacy of treatment of patients with pancolitis and left-sided ulcerative colitis of moderate severity, who received MMX mesalazine as monotherapy and MMX mesalazine combined with mesalazines in the form of microclysters and suppositories.Materials and methods. A comparative clinical evaluation of the outcomes of treatment of patients with moderate UC who received MMX mesalazine as monotherapy (group 1) and MMX mesalazine combined with topical mesalazine (microclysters, suppositories) (group 2) was carried out. 40 patients with UC (group 1) and 46 (group 2) were examined.Results and discussion. Two weeks after MMX mesalazine therapy initiation, 92.8% of patients in group 1 responded to MMX mesalazine therapy and continued using the drugs as monotherapy (without microclysters and suppositories). In group 1, 95.6% of patients responded to MMX mesalazine therapy and continued treatment with topical mesalazines (microclysters and suppositories). At week 12, 54.3% of 35 patients in group 1, who responded to MMX mesalazine therapy, achieved clinical remission, 45.7% achieved clinical endoscopic remission. The Mayo Score decreased from 8.0 ± 0.17 to 2.3 ± 0.3 points. At week 12, 57.1% of patients with UC in group 2, who responded to MMX mesalazine therapy, achieved clinical remission, and 42.9% achieved clinical and endoscopic remission. The Mayo Score decreased from 7.85 ± 0.14 to 2.4 ± 0.3 points. There was no statistically significant difference in the level of laboratory findings between the groups of patients at 12 weeks and at 52 weeks (p> 0.05).Conclusion. The long-term continuous administration of MMX mesalazine in patients with pancolitis and left-sided ulcerative colitis of moderate severity as monotherapy during the year is comparable in its efficacy with combined MMX mesalazine therapy and topical forms of mesalazine. 

2019 ◽  
pp. 80-86
Author(s):  
O. V. Knyazev ◽  
A. V. Kagramanova ◽  
A. A. Lishchinskaya ◽  
A. I. Parfenov

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 >2 g/day in combination with local mesalazine. Prolonged continuous use of Mesacol and Salofalk mesalazines for a year is comparable in efficacy.


2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S022-S024
Author(s):  
S Danese ◽  
S Vermeire ◽  
W Zhou ◽  
A Pangan ◽  
J Siffledeen ◽  
...  

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.


2021 ◽  
pp. 144-151
Author(s):  
O. V. Knyazev ◽  
A. V. Kagramanova ◽  
A. A. Lishchinskaya

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


2013 ◽  
Vol 7 ◽  
pp. S95 ◽  
Author(s):  
N. Inoue ◽  
K. Takabayashi ◽  
T. Takayama ◽  
K. Matsuoka ◽  
M. Naganuma ◽  
...  

2021 ◽  
Vol 2021 ◽  
pp. 1-13
Author(s):  
Xiaolei Liu ◽  
Yan Li ◽  
Kaichun Wu ◽  
Yongquan Shi ◽  
Min Chen

Aim. Increasing evidence supports the role of the gut microbiota in the etiology of ulcerative colitis (UC). Fecal microbiota transplantation (FMT) is a highly effective treatment against recurrent Clostridium difficile infection; however, its efficacy in UC is still controversial. A systematic review and meta-analysis was conducted to evaluate the efficacy and safety of FMT for treatment of active UC. Methods. We searched Cochrane, Medline, Web of Science, and Embase from inception to February 2020. Randomized controlled trials (RCTs) recruiting adults with active UC, which compared FMT with controls, were eligible. The primary outcome was combined clinical remission with endoscopic remission/response. Secondary outcomes included clinical remission, endoscopic remission, and serious adverse events. Relative risk (RR) with 95% confidence interval (CI) is reported. Results. Five RCTs with 292 participants were eligible for inclusion. When data were pooled for all patients, FMT was associated with a higher combined clinical remission with endoscopic remission/response; the RR of combined outcome not achieving after FMT vs. control was 0.79 (95% CI 0.70-0.88). FMT delivered via lower gastrointestinal route was superior to upper gastrointestinal route with regard to combined clinical remission with endoscopic remission/response ( RR = 0.79 , 95% CI 0.70-0.89). FMT with pooled donor stool ( RR = 0.69 , 95% CI 0.56-0.85) and higher frequency of administration ( RR = 0.76 , 95% CI 0.62-0.93) may be more effective with regard to clinical remission. There was no statistically significant difference in serious adverse events with FMT compared with controls ( RR = 0.98 , 95% CI 0.93-1.03). Conclusion. FMT shows a promising perspective with comparable safety and favorable clinical efficacy for the treatment of active UC in the short term. However, further larger, more rigorously conducted RCTs of FMT in UC are still needed in order to resolve the controversial questions.


2019 ◽  
Vol 13 (10) ◽  
pp. 1311-1317 ◽  
Author(s):  
Ajit Sood ◽  
Ramit Mahajan ◽  
Arshdeep Singh ◽  
Vandana Midha ◽  
Varun Mehta ◽  
...  

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.


Author(s):  
Serdar Başaranoğlu ◽  
Elif Ağaçayak ◽  
Ayşegül Deregözü ◽  
İlknur İnegöl Gümüş ◽  
Mustafa Acet ◽  
...  

<p><strong>OBJECTIVE:</strong> Uterine myomas are the most common benign pelvic tumours observed during the reproductive period.Increased risks of haemorrhage and postoperative morbidity lead professionals to avoid myomectomy at the time of Cesarean (C-section). The present study retrospectively analysed the data of patients who had undergone C-section only and those that had undergone C-section and simultaneous myomectomy.</p><p><strong>STUDY DESIGN:</strong> The data of 42 patients (Group 1) who had underwent caesarean myomectomy and of 50 patients underwent C-section only (Group 2) out of 92 patients that had been taken into C-section on the basis of obstetric indications were retrospectively analysed in this study. The relevant patient data were recorded with the inclusion of demographic data, gestational week, and preoperative and postoperative laboratory findings. Types, locations and sizes (the largest diameter) of individual myomas were identified and noted.</p><p><strong>RESULTS:</strong> The mean diameter of myomas was 66.3±30.2 mm. Ten patients that had underwent caesarean myomectomy (23.8%) developed a need for intensive care. No statistically significant difference was found in laboratory parameters between Group 1 and Group 2.</p><p><strong>CONCLUSION:</strong> Caesarean myomectomy, when performed by experienced obstetricians, does not lead to a significant increase in maternal morbidity and mortality. Although the short-term effects of this procedure are known, there is a need for the conduct of more comprehensive studies to establish its longterm effects on fertility or how it will affect the next pregnancy processes.</p>


2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S577-S578
Author(s):  
J Shin ◽  
G Seong ◽  
J H Song ◽  
S M Kong ◽  
T J Kim ◽  
...  

Abstract Background The advancement of therapeutic agents has made it possible to achieve endoscopic remission in inflammatory bowel disease. Consequently, the treatment goal of ulcerative colitis (UC) also has been changed to achieve endoscopic remission (ER). However, there was insufficient clinical evidence of whether a step-up treatment should be performed to achieve ER in clinical remission (CR) without ER. And there is inadequate data on the need to consider the distribution and severity of residual inflammation in UC. This retrospective study aimed to evaluate the prognostic significance (such as step-up therapy, hospitalisation, and colectomy) of the distribution and severity of residual inflammation in UC patients with CR. Methods A total of 134 UC patients who underwent endoscopic evaluation in CR and underwent colonoscopy more than 3 times between January 2000 and December 2018 were retrospectively reviewed. Patients were allocated by endoscopic healing state and distribution of inflammation to an ER (n = 33, 24.6%), residual non-rectal inflammation with patchy distribution (NRI) (n = 17, 12.7%) or residual rectal involvement with continuous or patchy distribution (RI) (n = 84, 62.7%). We reviewed the patient’s characteristics, endoscopic findings and ascertain poor outcome-free survival (PFS) until June 2019. Results In UC patient with CR, the PFS was significantly better in ER and NRI (p = 0.003). ER and NRI had similar PFS (p = 0.683). The baseline clinical characteristics of NRI and RI were not significantly different except for the pattern of residual inflammation (p &lt; 0.001). Multivariate analysis showed that NRI was a good prognostic factor of PFS for UC with CR Like ER (hazard ratio 0.53 (0.05–6.30), p = 0.615). Conclusion There was no statistically significant difference in the PFS between ER and NRI in the CR state of UC patients. Therefore, we propose selective escalation of treatment modality in CR patients, even if they do not reach ER.


2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S540-S541
Author(s):  
L Y Sassaki ◽  
D O Magro ◽  
R Saad-Hossne ◽  
J P Baima ◽  
C Flores ◽  
...  

Abstract Background Anti-TNF therapy represented a landmark in medical treatment of ulcerative colitis (UC). There is lack of data on the efficacy and safety of these agents in Brazilian patients, as public reimbursement is relatively recent. The present study aimed to analyze rates of clinical and endoscopic remission comparatively, between adalimumab (ADA) and infliximab (IFX), in Brazilian UC patients, and evaluate possible factors associated with remission after 1 year of treatment. Methods A national retrospective multicenter study (24 centers) was carried out including patients with moderate-to-severe UC treated with anti-TNF therapy. Disease activity was categorized using Mayo score at baseline, weeks 8, 26 and 52. Clinical remission was defined as a partial Mayo score ≤ 2. Endoscopic remission was defined as a Mayo endoscopic subscore ≤ 1. Patients were allocated in 2 groups (ADA and IFX) and a comparative efficacy study was performed. Statistical analysis: logistic regression model was used to study effects of predictor variables on categorical outcomes, such as presence or absence of remission at week 52. Statistical significance was assumed if p &lt;0.05. Results Overall, 393 patients were included (111 ADA and 282 IFX). The mean age was 41.86 ± 13.60 y, 61.58% women, most patients had extensive colitis (62.40%) and 19.39% previous exposure to biological agent. Overall, clinical remission rate was 66.78%, 71.62% and 82.82% at weeks 8, 26 and 52, respectively. Remission rates were higher in the IFX group at weeks 26 (75.12% vs. 62.65 %, p &lt;0.0001) and 52 (65.24% vs. 51.35%, p &lt;0.0001) – figure 1. Overall, endoscopic remission was observed in 50% of patients at week 26 and in 65.98% at week 52, with no difference between the two groups (p = 0.114). Colectomy was performed in 23 patients (5.99%). The variables associated with clinical remission after 1 year of treatment were age, non-prior exposure to biological therapy, use of IFX, endoscopic remission at week 26 and no need for optimization (table 1). The variables associated with endoscopic remission after 1 year were non-prior exposure to biological therapy, clinical and endoscopic remission at week 26 and no need for optimization. Conclusion In this national multicentric study, overall efficacy of anti-TNF therapy was similar to real world data with IFX and ADA. IFX treatment was associated with higher rates of clinical remission after 1 year in comparison to ADA. Patients naive to biological therapy presented higher rates of clinical and endoscopic remission. This is the first real world national study analyzing efficacy of anti-TNF agents in UC in Brazil.


VASA ◽  
2020 ◽  
Vol 49 (4) ◽  
pp. 281-284
Author(s):  
Atıf Yolgosteren ◽  
Gencehan Kumtepe ◽  
Melda Payaslioglu ◽  
Cuneyt Ozakin

Summary. Background: Prosthetic vascular graft infection (PVGI) is a complication with high mortality. Cyanoacrylate (CA) is an adhesive which has been used in a number of surgical procedures. In this in-vivo study, we aimed to evaluate the relationship between PVGI and CA. Materials and methods: Thirty-two rats were equally divided into four groups. Pouch was formed on back of rats until deep fascia. In group 1, vascular graft with polyethyleneterephthalate (PET) was placed into pouch. In group 2, MRSA strain with a density of 1 ml 0.5 MacFarland was injected into pouch. In group 3, 1 cm 2 vascular graft with PET piece was placed into pouch and MRSA strain with a density of 1 ml 0.5 MacFarland was injected. In group 4, 1 cm 2 vascular graft with PET piece impregnated with N-butyl cyanoacrylate-based adhesive was placed and MRSA strain with a density of 1 ml 0.5 MacFarland was injected. All rats were scarified in 96th hour, culture samples were taken where intervention was performed and were evaluated microbiologically. Bacteria reproducing in each group were numerically evaluated based on colony-forming unit (CFU/ml) and compared by taking their average. Results: MRSA reproduction of 0 CFU/ml in group 1, of 1410 CFU/ml in group 2, of 180 200 CFU/ml in group 3 and of 625 300 CFU/ml in group 4 was present. A statistically significant difference was present between group 1 and group 4 (p < 0.01), between group 2 and group 4 (p < 0.01), between group 3 and group 4 (p < 0.05). In terms of reproduction, no statistically significant difference was found in group 1, group 2, group 3 in themselves. Conclusions: We observed that the rate of infection increased in the cyanoacyrylate group where cyanoacrylate was used. We think that surgeon should be more careful in using CA in vascular surgery.


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