scholarly journals P616 Sustainability of thiopurines monotherapy in ulcerative colitis: a nationwide analysis from the epi-IIRN cohort

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S559-S559
Author(s):  
O Atia ◽  
C Friss ◽  
A Mendelovici ◽  
E Shteyer ◽  
E Orlanski-Meyer ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Treatment Duration ◽  
Cox Regression ◽  
Health Maintenance Organizations ◽  
Disease Course ◽  
Aminosalicylic Acid ◽  
Health Maintenance ◽  
Israeli Population ◽  
Pediatric Onset

Abstract Background Thiopurines have been long used to maintain remission in ulcerative colitis (UC) but are also associated with toxicity and therapeutic failure. We aimed to assess the sustainability rate of thiopurines commenced as monotherapy in UC, and to explore predictors of sustainability. Methods This study was performed on data from four Health Maintenance Organizations (HMOs), covering 98% of the Israeli population. We included all biologic-naïve UC patients diagnosed after 2005 and treated with thiopurines monotherapy for at least three months. Treatment with 5- aminosalicylic acid (ASA) was allowed if initiated prior to or during the first three months from initiation of thiopurines. Sustainability was defined as continued thiopurines treatment without switching therapy, adding biologics or requiring surgery. At most one short steroid course was allowed. Cox regression model was used to explore estimated predictors to sustainability. Results A total of 1,897 (370 [20%] pediatric-onset and 1,527 [80%] adults) thiopurines-treated patients were included with a 15,033 person-years of follow-up. The median time from UC diagnosis to initiation of thiopurines was 12.7 months (IQR 4.6–30.9), and the median treatment duration was 13.0 months (6.3–28.4). Sustainability rate was evident in 92% of patients after 6 months from initiation of thiopurines and 83%, 65% and 42% at one, three and five years, thereafter. Sustainability was associated with early initiation of thiopurines during disease course (HR 0.99 [95%CI 0.985–0.995]) and lack of 5-ASA at initiation of thiopurines (HR 0.7 [95%CI 0.6–0.8]). Conclusion As many as two thirds of biologic-naïve UC patients treated with thiopurines monotherapy sustain this treatment after five years, especially when initiated early and without 5-ASA.

scholarly journals DOP46 Sustainability rate of immunomodulators monotherapy in patients with Crohn’s Diseases: A population-based analysis from the epi-IIRN cohort

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S083-S083
Author(s):  
O Atia ◽  
C Friss ◽  
A Mendelovici ◽  
E Shteyer ◽  
D Yogev ◽  
...  
Keyword(s):  
Regression Model ◽  
Cox Regression ◽  
Health Maintenance Organizations ◽  
Population Based ◽  
Disease Course ◽  
Cox Regression Model ◽  
Health Maintenance ◽  
Israeli Population ◽  
Type Of Failure

Abstract Background Immunomodulators (IMM), including thiopurines and methotrexate (MTX), have been long used to maintain remission in Crohn’s disease (CD), both associated with remission, but also with toxicity and therapeutic failure. We aim to compare the sustainability of thiopurines and MTX commenced as monotherapy in patients with CD, and to explore predictors of sustainability. Methods This study was performed on data from four Health Maintenance Organizations (HMOs), covering 98% of the Israeli population. We included all biologic-naïve CD patients diagnosed after 2005 and treated with IMM monotherapy for at least three months. Sustainability was defined as continues IMM treatment without switching therapy, adding biologics or requiring surgery. In addition, at most one short steroid course was allowed. Cox regression model was used to explore estimated predictors to sustainability. To compare sustainability rate between thiopurines and MTX we used propensity score (PS) matching, and thereafter Cox regression model. Results A total of 4,891 (1,551 [32%] pediatric-onset and 3,340 [68%] adults) IMM-treated patients were included with 37,825 person-years of follow up, of whom 4,339 (89%) were treated with thiopurines and 552 (11%) with MTX. The median time from CD diagnosis to initiation of IMM was 6.1 months (IQR 1.7–19.7), and the median course duration was 11.9 months (6.1–25.3). Sustainability rate was recorded in 92% of patients after 6 months from initiation of IMM and 81%, 69% and 65% at one, three and five years, thereafter. The most common type of failure was escalation to biologics (67%), while 17% required repeated steroid courses and 15% underwent surgery. Sustainability was associated with earlier initiation of IMM during the disease course (HR 0.98 [95%CI 0.97–0.985]) and lack of steroids at initiation of IMM (HR 0.7 [95%CI 0.6–0.8]). A PS adjusted analysis that included 337 thiopurnes-treated patients individually matched with 337 MTX-treated patients, showed sustainability was significantly better with thiopurines (HR 0.7 [95%CI 0.5–0.8]). Conclusion Two thirds of biologic-naïve CD patients treated with IMM monotherapy sustain this treatment after five years, especially when initiated early during the disease course. Sustainability was more likely in those treated with thiopurines compared with MTX.

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 P296 Stopping 5-aminosalicylic acid in patients with ulcerative colitis who are in clinical remission does not increase risks of flare

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S325-S326
Author(s):  
J W Y Mak ◽  
N T K Yuen ◽  
T C F Yip ◽  
R H M Lam ◽  
B K H Lam ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Cox Regression ◽  
Controlled Trial ◽  
Blood Parameters ◽  
Aminosalicylic Acid ◽  
Healthcare Database ◽  
Increased Risk ◽  
One Year

Abstract Background 5-aminosalicylic acid (ASA) has been the mainstay of treatment for ulcerative colitis (UC). However, it is unclear whether the medication can be stopped in patients with stable disease. We aimed to examine whether 5-ASA can be safely withdrawn in UC patients who have been in steroid-free clinical remission for at least 1 year. Methods This is a retrospective cohort study using a territory-wide healthcare database in Hong Kong. Primary outcome was development of UC flare defined as a composite of new corticosteroid use, UC-related hospitalization or surgery within 5 years after stopping-5ASA. UC patients who were on oral 5-ASA ≥ 2grams daily for at least 1 year, who had C-reactive protein &lt;1mg/dL and no escalation of 5-ASA dosage, no UC-related hospitalization and no use of corticosteroid in the past 1 year were included. UC patients who were on biologics were excluded. Patients were classified as stopping 5-ASA if 5-ASA had ever been withdrawn for at least 90 days within the follow-up period. We performed multivariable Cox regression models adjusting for demographics, blood parameters and immunosuppressants used. Adjusted hazard ratio (aHR) with 95% confidence interval (CI) was reported comparing groups stopping 5-ASA and those continuing 5-ASA. Results A total of 1408 patients with UC were included with a median follow-up duration of 41.8 months [Interquartile range (IQR): 17.2-60 months)]. Stopping 5-ASA was not associated with an increased risk of UC flare (aHR 0.99, 95% CI 0.76-1.30, p=0.722). Higher haemoglobin level at baseline was protective against flare (aHR 0.91, 95% CI 0.85-0.97, p=0.03), while higher CRP level at baseline was associated with an increased risk of flare (aHR 1.06, 95% CI 1.03-1.09, p&lt;0.001). Results were similar in sensitivity analysis investigating stopping 5-ASA for ≥ 180 days which showed no difference in risk of flare comparing groups continuing and stopping 5-ASA (aHR 1.02, 95%CI 0.71-1.48,p=0.912). There were no differences in the risk of requiring colectomy (HR: 2.23, 95% CI 0.67-7.49, p=0.193) or development of colorectal cancer (HR: 0.76, 95% CI 0.22-2.65, p=0.671) in patients who stopped 5-ASA and those who continued 5-ASA. Conclusion Stopping 5-ASA in patients with UC who have been in clinical remission for over one year was not associated with increased risk of flare. These results should be validated in prospective randomized controlled trial.

scholarly journals DOP44 Long term outcomes of patients with untreated IBD - A population-based analysis from the epi-IIRN

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S081-S082
Author(s):  
R Magen Rimon ◽  
O Atia ◽  
C Friss ◽  
N Ledderman ◽  
S Greenfeld ◽  
...  
Keyword(s):  
Induction Therapy ◽  
Maintenance Treatment ◽  
Cox Regression ◽  
Drug Prescription ◽  
Health Maintenance Organizations ◽  
Population Based ◽  
Health Maintenance ◽  
Maintenance Medication ◽  
Israeli Population

Abstract Background Therapy in IBD is recommended in order to treat or prevent complications. In this nationwide study we aimed to assess the incidence of patients with IBD who were not receiving maintenance treatment after diagnosis and the duration of non-treatment. Methods This study was performed on data from four Health Maintenance Organizations (HMOs), covering 98% of the Israeli population. We included all patients with IBD diagnosed from 2005 to 2019. Non-treatment was defined as lack of drug prescription of maintenance medication for at least six months from diagnosis. Sustainability was defined as lack of maintenance medications and without IBD-related surgeries. Cox regression model was used to explore estimated predictors of sustainability. Results A total of 30,168 patients were diagnosed with IBD in Israel since 2005 (16,936 [56%] Crohn’s disease [CD] and 13,231 [44%] ulcerative colitis [UC]). A total of 5,448 (32%) patients with CD were untreated, compared to 5,158 (39%) with UC (OR 1.35 [95%CI 1.3–1.4]; p&lt;0.001). Non-treatment was more likely in adult compared to pediatric-onset (34% vs 21%, respectively, p&lt;0.001 in CD; and 41%% vs 22%, respectively, in UC; p&lt;0.001) (Figure 1). Sustainability rate in CD was 72%, 46%, 36% and 28% after one, two, five and ten years from diagnosis, while in UC the corresponding rates were 59%, 39%, 24% and 16%. In CD, sustainability was associated with older age at diagnosis (HR 0.996 [95%CI 0.994–0.998]) and no induction therapy (HR 0.7 [95%CI 0.6–0.9] compared to steroids). In UC, sustainability was associated only with female sex (HR 0.9 [95%CI 0.88–0.98]). Conclusion Most patients with IBD eventually require maintenance therapy. Lack of maintenance treatment is more common in UC. Nevertheless, a third of patients with CD and one quarter with UC who had no medical treatment at six months from diagnosis remained untreated for five years, especially in older patients with CD and those who did not require induction therapy, suggesting milder disease.

scholarly journals DOP39 Utilization and sustainability of biologics in UC - A nationwide study from the epi-IIRN

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S077-S078
Author(s):  
O Atia ◽  
D Yogev ◽  
C Friss ◽  
G Focht ◽  
E Orlanski-Meyer ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Health Maintenance Organizations ◽  
Continuous Treatment ◽  
First Year ◽  
Disease Course ◽  
Health Maintenance ◽  
Nationwide Study ◽  
One Year ◽  
Adjusted Model ◽  
Pediatric Onset

Abstract Background 25% of UC patients fail to respond to induction therapy with biologics. In this nationwide study we aimed to evaluate trends in biologics utilization and sustainability in UC during the last 15 years. Methods This study was performed on data from four the four Israeli Health Maintenance Organizations, covering 98% of the population. Sustainability was defined as continuous treatment without IBD-related surgeries and at most one short steroid course. Sustainability was compared across different biologics utilizing a propensity score (PS) weighted analysis, estimated by generalized boosted modeling (GBM). Results 13,231 patients were diagnosed with UC in Israel since 2005 (1,426 [11%] pediatric-onset,11,805 [89%] adult-onset), of whom 1,692 (13%) were ever treated with biologics (400 [24%] pediatric-onset, 1,292 adults [76%], OR 3.2 [95%CI 2.8–3.6]; p&lt;0.001) with a median of 6.4 years follow up (IQR 3.4–9.9). Infliximab was the most common first-line treatment in both children and adults (75% and 54%, respectively, p&lt;0.001). However, in recent years there was an increase in adalimumab and vedolizumab utilization in parallel with a decrease in infliximab (Figure). The rate of initiating biologics in the first year of diagnosis increased from from 11% during 2005–2010 to 25% during 2011–2014 and 61% since 2015 (p&lt;0.001). The use of combination therapy with immunomodulators is becoming less common and decreased with infliximab: from 36% in 2010 to 17% in 2018 (p&lt;0.001) and with adalimumab from 32% to 12%, respectively (p&lt;0.001). The sustainability rate in those treated with infliximab was 52% at one year from initiation of biologics, and 37% and 34% at three and five years, thereafter; compared to 55%, 43% and 40% with adalimumab and 72% and 67% after one and two years with vedolizumab. The primary non-response rate was 30% with infliximab, 31% with adalimumab and 16% with vedolizumab. Sustainability was associated with earlier initiation of biologics during the disease course (HR 0.9 [95%CI 0.85–0.95]). In the PS-adjusted model where vedolizumab served as the reference, the sustainability of both infliximab (HR 0.7 [95%CI 0.6–0.95]) and adalimumab (HR 0.8 [95%CI 0.6–0.99]) were lower. Compared with monotherapy, combination therapy increased the sustainability rate with both adalimumab (HR 0.3 [95%CI 0.2–0.6]) and infliximab (HR 0.4 [95%CI 0.-0.6]), but not with vedolizumab (HR 1.4 [95%CI 0.98–2.1]). Conclusion Biologics are being increasingly used in UC but only half of patients sustain treatment at one year. Treatment is commenced earlier during the disease course, and this is associated with improved sustainability. Sustainability rate is higher with vedolizumab, and in combination therapy of IMM and infliximab or adalimumab.

scholarly journals P246 Long-term prognosis of ulcerative colitis and its temporal changes between 1986 and 2015 in a population-based cohort in the Songpa-Kangdong district of Seoul, Korea

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S271-S271
Author(s):  
J M Cha ◽  
S H Park ◽  
K H Rhee ◽  
S N Hong ◽  
Y H Kim ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Cox Regression ◽  
Cumulative Risk ◽  
Population Based ◽  
Natural Course ◽  
Cox Regression Analysis ◽  
Mortality Ratio ◽  
Cumulative Risks

Abstract Background No population-based study has evaluated the natural course of ulcerative colitis (UC) over three decades in non-Caucasians. We aimed to assess the long-term natural course of Korean patients with UC in a population-based cohort. Methods This Korean population-based SK-IBD cohort included all patients (N = 1013) newly diagnosed with UC during 1986–2015. Disease outcomes and their predictors were evaluated. Results During the median follow-up of 105 months, the overall use of systemic corticosteroids, thiopurines, and anti-tumour necrosis factor (TNF) agents was 40.8%, 13.9%, and 6.5%, respectively. Over time, the cumulative risk of commencing corticosteroids decreased, whereas that of commencing thiopurines and anti-TNF agents increased. During follow-up, 28.7% of 778 patients with proctitis or left-sided colitis at diagnosis experienced proximal disease extension. A total of 28 patients (2.8%) underwent colectomy, demonstrating cumulative risks of colectomy at 1, 5, 10, 20, and 30 years after diagnosis of 1.0%, 1.9%, 2.2%, 5.1%, and 6.4%, respectively. Multivariate Cox regression analysis revealed that extensive colitis at diagnosis (hazard ratio [HR] 8.249, 95% confidence interval [CI] 2.394–28.430), ever use of corticosteroids (HR 6.437, 95% CI 1.440–28.773), and diagnosis in the anti-TNF era (HR 0.224, 95% CI 0.057–0.886) were independent predictors of colectomy. The standardised mortality ratio in UC patients was 0.725 (95% CI 0.508–1.004). Conclusion Korean UC patients may have a better clinical course than Western patients, as indicated by a lower colectomy rate. The overall colectomy rate has continued to decrease over the past three decades.

scholarly journals DOP15 Clinical relevance of endoscopic peri-appendiceal red patch in Ulcerative Colitis patients

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S054-S054
Author(s):  
M Reijntjes ◽  
L Heuthorst ◽  
K Gecse ◽  
A Mookhoek ◽  
W Bemelman ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Importance ◽  
Cross Sectional Study ◽  
Disease Course ◽  
Cross Sectional ◽  
Mayo Score ◽  
Disease Characteristics ◽  
Younger Age ◽  
Appendiceal Inflammation

Abstract Background Recently, increasing evidence is suggesting appendectomy as an alternative treatment approach for ulcerative colitis (UC), especially in case of pathological inflammation of the appendix. Therefore, pre-operative identification of appendiceal inflammation could be of clinical importance to predict efficacy of therapeutic appendectomy. This study assessed the incidence of peri-appendiceal red patch (PARP) on colonoscopy, with the aim to correlate PARP to patient and disease characteristics. In addition, the prognostic relevance of PARP on course of disease, and more specifically, histopathological findings of inflammation in resection specimens of the appendix were assessed, to analyze if PARP could potentially be used to identify patients eligible for appendectomy. Methods All consecutive patients with UC undergoing colonoscopy in 2014 or 2015 were included to determine the incidence of PARP in a cross-sectional study. Findings were correlated to patient and disease characteristics, upscaling of treatment during disease course and colectomy rates. Degree of inflammation of the appendix in case of subsequent appendectomy/colectomy was determined and results were compared between patients with and without PARP. Histological inflammation was scored by an independent pathologist using the Robarts histopathology index (RHI). Results In total, 249 patients with an eligible endoscopy report were included. The incidence of PARP was 17.7% (44/249). Patients with PARP were significantly younger and had a shorter disease course. PARP patients with active disease had proctitis more frequently, although not significant (29.4% vs 11.4%, p= 0.19). Out of 44 PARP patients, 27 (61.4%) were found in colonoscopies showing endoscopic Mayo score 0 or 1. Patients with PARP required significantly more upscaling of medical therapy (81.8% vs 58.0%, p= 0.03), and during the median follow up of 71 months the PARP patient group underwent colectomy more frequently (13.6% vs 4.9%, p=0.04). Eighteen appendices were available for histological analysis, of which 8 showed a PARP pre-operatively. Patients with PARP had a higher median Robarts Histology Index (RHI) score compared to patients without a PARP (13.5 vs 6.5 p&lt; 0.01). Conclusion PARP was predominantly found in UC patients with younger age and shorter disease duration and were demonstrated to have a more severe course of UC. Patients with PARP had a higher histopathological inflammation score. Since pathological inflammation of the appendix has been associated with improved efficacy of therapeutic appendectomy, it could be attractive to analyze if the presence of PARP might help in selecting patients more likely to respond to therapeutic appendectomy.

scholarly journals P672 The escalation of therapy or intervention (ETI) calculator for ulcerative colitis: does it have the potential to help outpatient capacity meet demand?

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S550-S551
Author(s):  
A J Walsh ◽  
L Matini ◽  
R Kantschuster ◽  
M Lepetyukh ◽  
D Simadibrata ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Outpatient Clinic ◽  
Activity Index ◽  
Resource Utilisation ◽  
Aminosalicylic Acid ◽  
Time Data ◽  
Therapeutic Decisions ◽  
Patient Reported ◽  
Treatment Escalation

Abstract Background Demand for outpatient clinic appointments for ulcerative colitis (UC) often exceeds capacity, since spaces are frequently assigned to routine follow-up of patients who are well. Demand might better be managed by targeting appointments for patients in need of therapeutic decisions. The TrueColours UC (TCUC) Escalation of Therapy or Intervention (ETI) calculator is a potential enabling tool. Methods TCUC is a web-based programme based on email prompts linked to validated, disease-specific indices. The ETI Calculator was created after logistic regression showed that patient-reported symptoms (Simple Clinical Colitis Activity Index) and quality of life (IBD Control-8) could calculate the probability of therapy escalation or an urgent intervention during an outpatient appointment (OPA, Figure 1). From June 2018 to August 2019, all OPA for 650 patients using TCUC and under standard OPA follow-up were examined. The probability of escalation at each OPA was calculated using the most recent prior SCCAI and IBD-Control scores (within 2 weeks of appointment). Clinic letters were assessed to determine whether treatment escalation or intervention had occurred during the OPA. Results Of 650 patients, 236 had a total of 403 OPAs. 210/403 (52%) of these OPAs resulted in no treatment escalation; 159/403 (40%) had escalation and 34/410 (8%) had de-escalation. An ETI calculator threshold set at 5% estimated probability of treatment escalation would have correctly identified 143/159 (90%) escalation events. 16/159 (10%) escalations were not correctly predicted: 12/16 were escalations of medication (oral 5-aminosalicylic acid, n = 3), azathioprine (2), methotrexate (1), increase infliximab dose (2), adalimumab (3), tofacitinib (1). Other escalations were endoscopy requests (2), dermatology/rheumatology referrals (2). Importantly, 6/16 (38%) had taken steroids within 1 month of data collection. 143/403 (35%) of OPAs could have been deferred using a 5% ETI threshold. In contrast, increasing the ETI threshold to 25% would have allowed 274/403 (68%) OPAs to be deferred but would have resulted in missing an additional 53 escalations. Conclusion A model that predicts the likelihood of treatment escalation or intervention during an OPA, based on real-time data entered by patients, has the potential to improve outpatient clinic resource utilisation. The calculator may not be valid to triage patients recently on steroids.

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