scholarly journals P466 Acute Severe Ulcerative Colitis in the modern era: biologic therapy-exposed patients and salvage therapy with intensified infliximab

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S457-S457
Author(s):  
K Fasoulas ◽  
K Soufleris ◽  
N Kafalis ◽  
P Kevrekidou ◽  
S Bouzoukas ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Medical Therapy ◽  
Salvage Therapy ◽  
Biologic Therapy ◽  
Rescue Therapy ◽  
Fecal Calprotectin ◽  
Disease Extent ◽  
Severe Ulcerative Colitis ◽  
Modern Era

Abstract Background Acute Severe Ulcerative Colitis (ASUC) is still associated with significant morbidity and risk of colectomy, almost 70 years since the landmark study of Truelove-Witts established steroid efficacy and 15 years since the Järnerot study introduced infliximab as an effective rescue therapy. It remains unclear if management of ASUC in the modern era (biologic-exposed patients and intensified infliximab regimens) leads to different outcomes. Methods A retrospective review of all recently hospitalized ASUC patients was performed. We aimed to compare rates of colectomy, response to steroids, and response to salvage infliximab in bio-naive and bio-exposed patients. Intensified infliximab was used as salvage therapy: 10 mg/kg infusions, aiming a trough level of at least 10 μg/ml at Week 10. We also tried to identify disease and patient related characteristics predictive of colectomy or response to medical therapy. Results 50 patients were included (male 66%, mean age: 47.4 years) and followed up for a mean of 24.2 months. 24 patients (48%) experienced ASUC while on biologic therapy: 11 on infliximab, 6 on vedolizumab, 5 on adalimumab, 2 on golimumab. Endoscopy showed deep ulcers at 23 patients (47%). Fecal calprotectin was > 1800 ng/ml in all patients. Half the patients (25) received rescue therapy with Infliximab due to steroid refractoriness. Eleven patients (22%) underwent colectomy, 2 (4%) of which during the index hospitalization. Although colectomy rates were similar among bio-naïve and bio-exposed (20% vs 25%, p:0.675), bio-exposed patients were more refractory to steroids (0dds Ratio:3.6 ;95% CI:1.01–13.2, p:0.047). Response to rescue infliximab was similar (Odds Ratio:0.45 ;95% CI:0.13–1.5, p:0.215), even in patients failing standard dosed infliximab. High CRP levels (4.89 mg/dl vs 2.64 mg/dl, p:0.014) and low albumin levels (3.4 g/dl vs 3.9 g/dl, p:0.013) were predictive of colectomy in contrast to endoscopic severity and disease extent. Conclusion ASUC remains a therapeutic challenge in the modern era, with considerable refractoriness to medical therapy and colectomy risk: 50% of our group of ASUC patients responded to steroids and 22% underwent colectomy within two years of follow-up. High inflammatory burden, depicted by high CRP values and hypoalbuminemia can predict need for colectomy. Bio-exposed patients were more refractory to steroids but they showed comparable response to intensified infliximab, so they can be managed in the same way, at least until therapy with small molecules proves more efficient by future studies.

scholarly journals Long-term outcomes of acute severe ulcerative colitis in the rescue therapy era: A multicentre cohort study

2020 ◽  
pp. 205064062097740
Author(s):  
Stefano Festa ◽  
Maria L Scribano ◽  
Daniela Pugliese ◽  
Cristina Bezzio ◽  
Mariabeatrice Principi ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Tumour Necrosis ◽  
Rescue Therapy ◽  
Tumour Necrosis Factor Alpha ◽  
Necrosis Factor Alpha ◽  
Severe Ulcerative Colitis ◽  
Factor Alpha ◽  
Necrosis Factor

Background The long-term course of ulcerative colitis after a severe attack is poorly understood. Second-line rescue therapy with cyclosporine or infliximab is effective for reducing short-term colectomy but the impact in the long-term is controversial. Objective The purpose of this study was to evaluate the long-term course of acute severe ulcerative colitis patients who avoid early colectomy either because of response to steroids or rescue therapy. Methods This was a multicentre retrospective cohort study of adult patients with acute severe ulcerative colitis admitted to Italian inflammatory bowel disease referral centres from 2005–2017. All patients received intravenous steroids, and those who did not respond received either rescue therapy or colectomy. For patients who avoided early colectomy (within three months from the index attack), we recorded the date of colectomy, last follow-up visit or death. The primary end-point was long-term colectomy rate in patients avoiding early colectomy. Results From the included 372 patients with acute severe ulcerative colitis, 337 (90.6%) avoided early colectomy. From those, 60.5% were responsive to steroids and 39.5% to the rescue therapy. Median follow-up was 44 months (interquartile range, 21–85). Colectomy-free survival probability was 93.5%, 81.5% and 79.4% at one, three and five years, respectively. Colectomy risk was higher among rescue therapy users than in steroid-responders (log-rank test, p = 0.02). At multivariate analysis response to steroids was independently associated with a lower risk of long-term colectomy (adjusted odds ratio = 0.5; 95% confidence interval, 0.2–0.8), while previous exposure to anti-tumour necrosis factor alpha agents was associated with an increased risk (adjusted odds ratio = 3.0; 95% confidence interval, 1.5–5.7). Approximately 50% of patients required additional therapy or new hospitalization within five years due to a recurrent flare. Death occurred in three patients (0.9%). Conclusions Patients with acute severe ulcerative colitis avoiding early colectomy are at risk of long-term colectomy, especially if previously exposed to anti-tumour necrosis factor alpha agents or if rescue therapy during the acute attack was required because of steroid refractoriness.

scholarly journals P562 5-ASA in ulcerative colitis: Are they really needed in the biological therapy era?

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S474-S474
Author(s):  
C Arieira ◽  
F Dias de Castro ◽  
T Cúrdia Gonçalves ◽  
M J Moreira ◽  
J Cotter
Keyword(s):  
Colorectal Cancer ◽  
Ulcerative Colitis ◽  
Biologic Therapy ◽  
Fecal Calprotectin ◽  
Inflammatory Biomarkers ◽  
Faecal Calprotectin ◽  
Reactive Protein ◽  
Maintenance Of Remission ◽  
Treatment Escalation

Abstract Background Biologic therapy has demonstrated efficacy for induction and maintenance of remission in ulcerative colitis (UC). However, it remains unclear whether oral aminosalicylates (5-ASA) should be continued or stopped after treatment escalation to biologics. The aim of the study was to evaluate differences in inflammatory biomarkers or the occurrence of complications in UC patients being treated with a combination of 5-ASA and biologics vs. biologics alone. Methods Retrospective study, including patients with UC and on biologic therapy with a minimum follow-up of 6 months. Collected inflammatory biomarkers were faecal calprotectin, C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). The occurrence of complications was defined as the need of hospitalisation, need of corticosteroids or other top-up therapy, surgery and the occurrence of dysplasia or colorectal cancer. Results We included 65 patients with UC, 56.9% female with a mean age of 32.8 (±12.8) years. The median follow-up was 30 (6–132) months. Regarding extension, 61.5% were E3, 35.4% E2 and 3.1% E1. While 44 patients (67.7%) were on 5-ASA and biologics (infliximab = 32, adalimumab = 6, vedolizumab = 6), 21 (32.3%) were on biologics alone (infliximab = 13, adalimumab = 3, vedolizumab = 5). The median duration of biologic therapy was 30 (6–126) months. Regarding baseline characteristics, including age, gender, duration of the disease or biologic therapy and age at UC diagnosis, there were no differences between groups. No differences regarding inflammatory biomarkers were observed – fecal calprotectin (p = 0.39), CRP (p = 0.9) and ESR (p = 0.61). No differences were found regarding complications, namely the need of hospitalisation (p = 0.06) or need of corticosteroids (p = 0.89). Only one patient developed dysplasia (under infliximab and 5-ASA). Any of the included patients needed surgery or developed colorectal cancer. Conclusion About two-thirds of the UC patients under biologics are co-treated with 5-ASA. No differences between UC patients under combination biologics+5-ASA vs. biologics alone were found regarding inflammatory biomarkers or the occurrence of complications. These results raise the question if continuing 5-ASA in UC patients under biologics is really necessary.

scholarly journals Efficacy of tofacitinib as a «rescue therapy» in patients with severe ulcerative colitis

2021 ◽  
Vol 20 (3) ◽  
pp. 43-50
Author(s):  
D. V. Podolskaya ◽  
M. V. Shapina ◽  
T. A. Baranova ◽  
I. A. Tishaeva ◽  
T. L. Alexandrov ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Rescue Therapy ◽  
Clinical Manifestations ◽  
Stool Frequency ◽  
Line Treatment ◽  
Second Line ◽  
Severe Ulcerative Colitis ◽  
Laboratory Changes ◽  
Time Of Administration

AIM: to evaluate the effectiveness of tofacitinib as a second line treatment.PATIENTS AND METHODS: the study included 12 patients, 4 (33.34%) males and 8 (66.66%) females. The median age was 41 ± 5 years. All patients admitted to the hospital with a severe flare-up of ulcerative colitis, which was the inclusion criterion in this study. Clinical manifestations, laboratory parameters, and colonoscopy were done at the time of administration of tofacitinib, on days 3 and 7, and after 12 weeks.RESULTS: a fast clinical response on 3 day of treatment, reduction in stool frequency, decrease blood in stool was noted in 10 (83.3%) patients. After 7 days from the start of TFCS therapy, all patients showed a decrease from severe activity to mild activity, as well as a decrease in inflammatory blood markers and hemoglobin levels. During the follow-up for 12 weeks, 100% of patients showed positive clinical and laboratory changes. In 10 (83.4%) patients, remission or maintenance of negligible minimal activity was noted.CONCLUSION: the results obtained show that the use of TFTB in hormone-resistant patients can be effective as a second line of “rescue therapy”.

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 Efficacy of tofacitinib as a «rescue therapy» in patients with severe ulcerative colitis

2021 ◽  
Vol 20 (3) ◽  
pp. 43-50
Author(s):  
D. V. Podolskaya ◽  
M. V. Shapina ◽  
T. A. Baranova ◽  
I. A. Tishaeva ◽  
T. L. Alexandrov ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Rescue Therapy ◽  
Clinical Manifestations ◽  
Stool Frequency ◽  
Line Treatment ◽  
Second Line ◽  
Severe Ulcerative Colitis ◽  
Laboratory Changes ◽  
Time Of Administration

AIM: to evaluate the effectiveness of tofacitinib as a second line treatment.PATIENTS AND METHODS: the study included 12 patients, 4 (33.34%) males and 8 (66.66%) females. The median age was 41 ± 5 years. All patients admitted to the hospital with a severe flare-up of ulcerative colitis, which was the inclusion criterion in this study. Clinical manifestations, laboratory parameters, and colonoscopy were done at the time of administration of tofacitinib, on days 3 and 7, and after 12 weeks.RESULTS: a fast clinical response on 3 day of treatment, reduction in stool frequency, decrease blood in stool was noted in 10 (83.3%) patients. After 7 days from the start of TFCS therapy, all patients showed a decrease from severe activity to mild activity, as well as a decrease in inflammatory blood markers and hemoglobin levels. During the follow-up for 12 weeks, 100% of patients showed positive clinical and laboratory changes. In 10 (83.4%) patients, remission or maintenance of negligible minimal activity was noted.CONCLUSION: the results obtained show that the use of TFTB in hormone-resistant patients can be effective as a second line of “rescue therapy”.

Does Hospitalization Predict the Disease Course in Ulcerative Colitis? Prevalence and Predictors of Hospitalization and Re- Hospitalization in Ulcerative Colitis in a Population-based Inception Cohort (2000-2012)

2015 ◽  
Vol 24 (3) ◽  
pp. 287-292 ◽  
Author(s):  
Petra A. Golovics ◽  
Laszlo Lakatos ◽  
Michael D. Mandel ◽  
Barbara D. Lovasz ◽  
Zsuzsanna Vegh ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Cox Regression ◽  
Diagnostic Procedures ◽  
Population Based ◽  
Disease Course ◽  
Inception Cohort ◽  
Disease Extent ◽  
Cox Regression Analysis ◽  
Hospitalization Rates

Background & Aims: Limited data are available on the hospitalization rates in population-based studies. Since this is a very important outcome measure, the aim of this study was to analyze prospectively if early hospitalization is associated with the later disease course as well as to determine the prevalence and predictors of hospitalization and re-hospitalization in the population-based ulcerative colitis (UC) inception cohort in the Veszprem province database between 2000 and 2012. Methods: Data of 347 incident UC patients diagnosed between January 1, 2000 and December 31, 2010 were analyzed (M/F: 200/147, median age at diagnosis: 36, IQR: 26-50 years, follow-up duration: 7, IQR 4-10 years). Both in- and outpatient records were collected and comprehensively reviewed. Results: Probabilities of first UC-related hospitalization were 28.6%, 53.7% and 66.2% and of first re-hospitalization were 23.7%, 55.8% and 74.6% after 1-, 5- and 10- years of follow-up, respectively. Main UC-related causes for first hospitalization were diagnostic procedures (26.7%), disease activity (22.4%) or UC-related surgery (4.8%), but a significant percentage was unrelated to IBD (44.8%). In Kaplan-Meier and Cox-regression analysis disease extent at diagnosis (HR extensive: 1.79, p=0.02) or at last follow-up (HR: 1.56, p=0.001), need for steroids (HR: 1.98, p<0.001), azathioprine (HR: 1.55, p=0.038) and anti-TNF (HR: 2.28, p<0.001) were associated with the risk of UC-related hospitalization. Early hospitalization was not associated with a specific disease phenotype or outcome; however, 46.2% of all colectomies were performed in the year of diagnosis. Conclusion: Hospitalization and re-hospitalization rates were relatively high in this population-based UC cohort. Early hospitalization was not predictive for the later disease course.

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 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.

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