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 DOP35 Ambulatory care management of 70 patients with Acute Severe Ulcerative Colitis in comparison to 700 inpatients: Insights from a multicentre UK cohort study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S073-S074
Author(s):  
K V Patel ◽  
J Segal ◽  
S Sebastian ◽  
S Subramanian ◽  
T Conley ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Ambulatory Care ◽  
Rescue Therapy ◽  
Corticosteroid Treatment ◽  
Inpatient Setting ◽  
Close Monitoring ◽  
Severe Ulcerative Colitis ◽  
Significant Difference ◽  
Secondary Outcomes

Abstract Background Acute severe ulcerative colitis (ASUC) traditionally requires inpatient hospital management for intravenous therapies and/or colectomy. Patients with ASUC can deteriorate rapidly and hence require close monitoring of vital signs correlated with clinical, biochemical and radiological investigations. Traditionally, patients are admitted to hospital to facilitate endoscopic assessment, exclude concomitant infective complications, monitor response to first-line corticosteroid treatment and determine the need for and timing of rescue therapy and/or colectomy. Ambulatory care pathways, which utilise outpatient monitoring and drug delivery, have been shown to deliver safe and effective treatment for conditions which have historically mandated hospitalisation e.g. pulmonary embolus. To date there are a paucity of data regarding the use of ambulatory pathways in ASUC cohorts. We used data from PROTECT, a UK multicentre observational COVID-19 i (IBD) study, to report the extent, safety and effectiveness of ASUC ambulatory pathways. Methods Adults (≥ 18 years old) meeting Truelove and Witts criteria between 01/01/2019- 01/06/2019 and 01/03/2020–30/06/2020 were recruited to PROTECT (Figure 1). We utilised demographic, disease phenotype, treatment outcomes and 3-month follow-up data. Primary outcome was rate of rescue therapy and/or colectomy. Secondary outcomes included corticosteroid response, response to rescue therapy, colectomy, mortality and hospital readmission within 3-months. We compared outcomes in 3 cohorts: i) patients treated entirely in inpatient setting; ambulatory patients subdivided into ii) patients hospitalised and subsequently discharged to ambulatory care; iii) patients managed as ambulatory from diagnosis . Results 38%(23/60) participating hospitals used ambulatory pathways. Of 770 eligible patients, 700(91%) patients received entirely inpatient care, 55(7%) patients were discharged to ambulatory pathways and 15(2%) patients were managed as ambulatory from diagnosis. The rate of rescue therapy and/or colectomy (49%[339/696] vs 41%[22/54] vs 67%[10/15], respectively, p=0.18) (figure 2) and secondary outcomes were similar among all three cohorts. After 3-months follow up from the index ASUC diagnosis there was no significant difference in either rate of UC flare, readmission to hospital with UC flare or colectomy between the cohorts. Conclusion In the largest description of ambulatory ASUC care to date, we report an emerging practice which challenges treatment paradigms. Our data suggest ambulatory ASUC treatment may be safe and effective in selected patients but further studies exploring clinical and cost effectiveness as well as patient and physician acceptability are needed.

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 P404 Prolonged steroid exposure prior to admission is associated with increased likelihood of rescue therapy and colectomy in acute severe ulcerative colitis

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S373-S374
Author(s):  
A Barnes ◽  
P Spizzo
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Rescue Therapy ◽  
Electronic Record ◽  
High Dose ◽  
Retrospective Case ◽  
Severe Ulcerative Colitis ◽  
Inflammatory Bowel ◽  
One Year

Abstract Background Steroid exposure has been associated with poorer outcomes following colectomy in acute severe ulcerative colitis. Current treatment algorithms suggest three days of high dose intravenous steroid before the decision to commence rescue therapy. We aimed to look at medium-term outcomes in acute severe ulcerative colitis and their predictors including steroid exposure prior to admission. Methods A retrospective case note and electronic record review were conducted at a tertiary inflammatory bowel disease referral centre of admissions for acute severe ulcerative colitis meeting Truelove and Witts criteria from 2013 to 2019. Identified admissions were categorised as: not on steroid prior to admission or on steroid for less than one week prior to admission, on steroid for over one week prior to admission, and on steroid for over one month prior to admission. Data were analysed using Chi-squared test and Fisher’s exact test as appropriate. Results In total, 109 admissions were identified for acute severe ulcerative colitis meeting Truelove and Witts criteria over 2013 to 2019. Rescue therapy was significantly more likely in patients with over one week of steroid exposure prior to admission (76.0% vs. 28.5%, p = 0.0001). Prior steroid exposure was not associated with failure of medical rescue therapy (p = 0.42). Patients with steroid exposure for at least one week prior to admission trended towards increased likelihood to undergo colectomy during admission (32.0% vs. 16.6%, p = 0.0.09) and were significantly more likely to undergo colectomy within one year of admission (44.0% vs. 21.4%, p = 0.028). Excluding patients with a first presentation of inflammatory bowel disease showed that patients with steroid exposure for at least one week prior to admission trended towards significance to undergo colectomy during admission (32.0% vs. 13.2%, p = 0.05) and were significantly more likely to undergo colectomy within one year of admission (44.0% vs. 20.7%, p = 0.036). Readmissions within one year of acute severe ulcerative colitis admission were not significantly different (40.0% vs. 29.7%, p = 0.33). Conclusion Prolonged steroid exposure prior to admission was associated with an increased likelihood of rescue therapy but was not predictive of response to medical rescue therapy. Colectomy rates at one year were significantly higher with over one week of steroid exposure prior to admission. Consideration should be given to early commencement of rescue therapy in those with prolonged steroid exposure prior to admission.

scholarly journals Acute severe ulcerative colitis: management advice for internal medicine and emergency physicians

2021 ◽  
Author(s):  
Konstantina Rosiou ◽  
Christian Philipp Selinger
Keyword(s):  
Ulcerative Colitis ◽  
Rescue Therapy ◽  
Medical Emergency ◽  
Close Monitoring ◽  
Surgical Morbidity ◽  
Severe Ulcerative Colitis ◽  
General Management ◽  
Management Measures ◽  
Management Advice ◽  
Team Setting

AbstractAcute severe ulcerative colitis is a medical emergency that warrants in-patient management. This is best served within a multidisciplinary team setting in specialised centres or with expert consultation. Intravenous corticosteroids remain the cornerstone in the management of ASUC and should be initiated promptly, along with general management measures and close monitoring of patients. Unfortunately, one-third of patients will fail to respond to steroids. Response to intravenous corticosteroid therapy needs to be assessed on the third day and rescue therapies, including cyclosporine and infliximab, should be offered to patients not responding. Choice of rescue therapy depends on experience, drug availability and factors associated with each individual patient, such as comorbidities, previous medications or contra-indications to therapy. Patients who have not responded within 7 days to rescue therapy must be considered for surgery. Surgery is a treatment option in ASUC and should not be delayed in cases of failure of medical therapy, because such delays increase surgical morbidity and mortality. This review summarises the current management of acute severe ulcerative colitis and discusses potential future developments.

scholarly journals Fecal calprotectin is a useful biomarker for predicting the clinical outcome of granulocyte and monocyte adsorptive apheresis in ulcerative colitis patients: a prospective observation study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Nobuhiro Ueno ◽  
Yuya Sugiyama ◽  
Yu Kobayashi ◽  
Yuki Murakami ◽  
Takuya Iwama ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Outcome ◽  
Sensitivity And Specificity ◽  
Reduction Rate ◽  
Fecal Calprotectin ◽  
Remission Induction ◽  
Clinical Activity ◽  
Observation Study ◽  
Mayo Score ◽  
Adsorptive Apheresis

Abstract Background Granulocyte and monocyte adsorptive apheresis (GMA) is widely used as a remission induction therapy for active ulcerative colitis (UC) patients. However, there are no available biomarkers for predicting the clinical outcome of GMA. We investigated the utility of Fecal calprotectin (FC) as a biomarker for predicting the clinical outcome during GMA therapy in active UC patients. Methods In this multicenter prospective observation study, all patients received 10 sessions of GMA, twice a week, for 5 consecutive weeks. FC was measured at entry, one week, two weeks, and at the end of GMA. Colonoscopy was performed at entry and after GMA. The clinical activity was assessed based on the partial Mayo score when FC was measured. Clinical remission (CR) was defined as a partial Mayo score of ≤ 2 and endoscopic remission (ER) was defined as Mayo endoscopic subscore of either 0 or 1. We analyzed the relationships between the clinical outcome (CR and ER) and the change in FC concentration. Result Twenty-six patients were included in this study. The overall CR and ER rates were 50.0% and 19.2%, respectively. After GMA, the median FC concentration in patients with ER was significantly lower than that in patients without ER (469 mg/kg vs. 3107 mg/kg, p = 0.03). When the cut-off value of FC concentration was set at 1150 mg/kg for assessing ER after GMA, the sensitivity and specificity were 0.8 and 0.81, respectively. The FC concentration had significantly decreased by one week. An ROC analysis demonstrated that the reduction rate of FC (ΔFC) at 1 week was the most accurate predictor of CR at the end of GMA (AUC = 0.852, P = 0.002). When the cut-off value of ΔFC was set at ≤ 40% at 1 week for predicting CR at the end of GMA, the sensitivity and specificity were 76.9% and 84.6%, respectively. Conclusion We evaluated the utility of FC as a biomarker for assessing ER after GMA and predicting CR in the early phase during GMA in patients with active UC. Our findings will benefit patients with active UC by allowing them to avoid unnecessary invasive procedures and will help establish new strategies for GMA.

scholarly journals Tofacitinib: An Option for Acute Severe Ulcerative Colitis?

2021 ◽  
pp. 1-3
Author(s):  
Sara Santos ◽  
Verónica Gamelas ◽  
Rita Saraiva ◽  
Guilherme Simões ◽  
Joana Saiote ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Improvement ◽  
Rescue Therapy ◽  
New Drugs ◽  
Multiple Drug ◽  
Disease Course ◽  
Efficacy And Safety ◽  
Severe Ulcerative Colitis ◽  
Rapid Absorption

Tofacitinib has emerged as a new option for ulcerative colitis. Its rapid absorption, metabolism, and clinical improvement make it an interesting option for rescue therapy in acute severe ulcerative colitis (ASUC), a situation with limited therapeutic options in patients with a long-term disease course and multiple drug failure. The management of ASUC in this setting becomes challenging, underlying the need for new drugs and data on their efficacy and safety. We describe 2 cases of acute episodes in which tofacitinib was used as a rescue therapy.

scholarly journals 19 Colectomy Rate for Moderate to Severe Ulcerative Colitis with Biologics

2021 ◽  
Vol 108 (Supplement_2) ◽  
Author(s):  
J W H Koh ◽  
C H Ng ◽  
M H Lee ◽  
Y H Chin ◽  
Z H Ong ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Current Literature ◽  
Biologic Therapy ◽  
Meta Analysis ◽  
Severe Ulcerative Colitis ◽  
Before And After ◽  
Arcsine Transformation ◽  
One Year

Abstract Introduction Biologics are recommended by both the ACG and ECCO community for the treatment of ulcerative colitis. Yet, current literature has yet to estimate the rate of colectomies after biologic therapy, and thus a pooled meta-analysis was conducted the rate of colectomies in 1month, 6 months, 1 year, 2years and five years after biologics. Method Medline and Embase were searched for articles examining biologics use in moderate to severe UC or acute severe UC (ASUC) from inception to 21st May 2020. Analysis of proportions were undertaken after a freeman-tukey double arcsine transformation. Results The pooled overall colectomy rates of ASUC and moderate to severe UC were 9% (CI: 4% - 14%) at one month, 18% (CI: 13% - 25%) at six months, 21% (CI:16% - 27%) at one year, 29% (CI:24% - 34%) at two years and 38% (CI:30% - 45%) at five years. Additionally, colectomy rates were consistently lower comparing between articles before and after 2010. At one-year, overall colectomy rate following infliximab use was at 25%, golimumab at 15%, vedolizumab at 14%, and adalimumab at 3%. Conclusions Colectomy rates in the era of biologics ranged from 8% to 38% and lower post-2010 showing significant improvement in management and supporting the utility of biologics in Ulcerative colitis management.

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.

Sign in / Sign up

Export Citation Format

Share Document