scholarly journals P338 The effectiveness of a standardised biologic care pathway in the management and treatment of inflammatory bowel disease

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S325-S325
Author(s):  
N Willett ◽  
C G Heisler ◽  
N Nazer ◽  
B Currie ◽  
K Phalen-Kelly ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Cohort Study ◽  
Combination Therapy ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Multivariate Analyses ◽  
Care Pathway ◽  
Endoscopic Remission ◽  
Inflammatory Bowel ◽  
The Mean

Abstract Background inflammatory bowel disease (IBD) is a class of chronic immune-mediated diseases. Biologics have revolutionised the treatment of IBD. Existing literature suggests significant variation exists in the use of biologic treatment among physicians, from provider-specific prescribing to completion of the pre-biologic workup. These differences may influence the effectiveness of achieving and maintaining long-term remission. Clinical care pathways can standardise the use of biologics, improve patient outcomes, and increase consistency of care. The aim of the project was to determine whether the use of biologics to treat IBD managed within a standardised biologic care pathway (BCP) is safer and more effective compared with the current standard of care. Methods This was a retrospective, real-world cohort study of a prospectively implemented evidence-based BCP at the Nova Scotia Collaborative IBD (NSCIBD) program between 2015 and 2019. Patient inclusion criteria consisted of an adult with a diagnosis of IBD (including Crohn’s disease, ulcerative colitis, IBD-Unclassified) aged 18 years or older who was managed within the NSCIBD program. Preliminary descriptive analyses of the data are presented. Data collection is ongoing and multivariate analyses will be presented in full at ECCO. Results In total 249 patients were included in the cohort study (111 BCP patients, 138 non-BCP patients). The mean age was 49 years (range of 17–86 years). Sixty-nine per cent (171/249) of patients were diagnosed with CD, 28% (70/249) with UC, and 3% (8/249) with IBD-U. The mean duration of disease was 13 years (range of 0–36 years). Use of combination therapy was similar between the cohorts with 64% of BCP patients (n = 102) and 63% of non-BCP patients (n = 123) on combination therapy. Thirty-eight per cent of the BCP cohort required dosing interval changes vs. 29% in the non-BCP cohort (0.24 fold higher in BCP cohort). Seventy-one per cent of the BCP patients were exposed to TDM vs. 41% of the non-BCP cohort (0.40-fold more TDM in pathway cohort). Although 34% of BCP patients and 38% of non-BCP cohort patients reached clinical remission (n = 103 and 125, respectively), 38% of BCP patients and 21% of non-BCP patients achieved endoscopic remission (0.5-fold lower in the non-BCP cohort), (n = 29 and 53, respectively). Conclusion Preliminary analyses suggest patients managed within a BCP have their biologic management guided more often by the results of TDM and objective biomarkers than those not managed within a BCP. Although clinical remission was observed to be similar between the cohorts, attainment of endoscopic remission was more likely amongst patients managed within the BCP. Additional multivariate analyses will be presented at ECCO with a larger cohort size.

scholarly journals A157 THE EFFECTIVENESS OF A STANDARDIZED BIOLOGIC CARE PATHWAY IN THE MANAGEMENT AND TREATMENT OF INFLAMMATORY BOWEL DISEASE

2020 ◽  
Vol 3 (Supplement_1) ◽  
pp. 21-22
Author(s):  
N Willett ◽  
C Heisler ◽  
N Nazer ◽  
B Currie ◽  
K Phalen-Kelly ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Cohort Study ◽  
Combination Therapy ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Multivariate Analyses ◽  
Care Pathway ◽  
Endoscopic Remission ◽  
Inflammatory Bowel ◽  
The Mean

Abstract Background Inflammatory Bowel Disease (IBD) is a class of chronic immune-mediated diseases. Biologics have revolutionized the treatment of IBD. Existing literature suggests significant variation exists in the use of biologic treatment among physicians, from provider-specific prescribing to completion of the pre-biologic workup. These differences may influence the effectiveness of achieving and maintaining long-term remission. Clinical care pathways may serve to standardize the use of biologics in the treatment of IBD leading to improvements in patient outcomes and consistency of care provided from different specialists. Aims To determine if the use of biologics to treat IBD managed within a standardized biologic care pathway (BCP) is safer and more effective compared to the current standard of care. Methods This was a retrospective, real-world cohort study of a prospectively implemented evidence-based BCP at the Nova Scotia Collaborative IBD (NSCIBD) program between 2015 and 2019. Patient inclusion criteria consisted of any adult with a diagnosis of IBD (including Crohn’s Disease, ulcerative colitis, IBD-Unclassified) aged 18 years or older who was managed within the NSCIBD program. Preliminary descriptive analyses of the data are presented. Data collection is ongoing and multivariate analyses will be presented in full at CDDW. Results In total 249 patients were included in the cohort study (111 BCP patients, 138 non-BCP patients). The mean age was 49 years (range of 17–86 years). Sixty-nine percent (171/249) of patients were diagnosed with CD, 28% (70/249) with UC, and 3% (8/249) with IBD-U. The mean duration of disease was 13 years (range of 0–36 years). Use of combination therapy was similar between the cohorts with 64% of BCP patients (n=102) and 63% of non-BCP patients (n=123) on combination therapy. Thirty-eight percent of the BCP cohort required dosing interval changes vs. 29% in the non-BCP cohort (0.24 fold higher in BCP cohort). Seventy-one percent of the BCP patients were exposed to TDM vs. 41% of the non-BCP cohort (0.40-fold more TDM in pathway cohort). Although 34% of BCP patients and 38% of non-BCP cohort patients reached clinical remission (n=103 and 125, respectively), 38% of BCP patients and 21% of non-BCP patients achieved endoscopic remission (0.5-fold lower in the non-BCP cohort), (n=29 and 53, respectively). Conclusions Preliminary analyses suggest patients managed within a BCP have their biologic management guided more often by the results of TDM and objective biomarkers than those not managed within a BCP. Although clinical remission was observed to be similar between the cohorts, attainment of endoscopic remission was more likely amongst patients managed within the BCP. Additional multivariate analyses will be presented at CDDW with a larger cohort size. Funding Agencies None

scholarly journals P226 Assessing the effectiveness of the nurse navigator role in an inflammatory bowel disease medical home: A retrospective cohort study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S255-S255
Author(s):  
C G Heisler ◽  
K Gawdat ◽  
N Nazer ◽  
M Stewart ◽  
B Currie ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Cohort Study ◽  
Healthcare System ◽  
Bowel Disease ◽  
Retrospective Cohort Study ◽  
Medical Home ◽  
Retrospective Cohort ◽  
Nurse Navigator ◽  
Inflammatory Bowel ◽  
The Mean

Abstract Background Patients living with chronic illnesses require long-term and often repeated interactions with the healthcare system. inflammatory bowel disease (IBD) is an incurable, chronic gastrointestinal disease which frequently flares and remits. The nurse navigator (NN) serves as the point of first contact for IBD connecting patients with their multidisciplinary care team in order to facilitate and expedite assessment, treatment and navigation through the healthcare system with the goal of improving disease-related outcomes while reducing healthcare system burden. The aim of this study was to assess the impact of implementation of an IBD NN role within a multidisciplinary IBD Medical home on access to care, disease-related outcomes, patient satisfaction with care, and healthcare resource use. Methods This was a retrospective cohort study comparing an IBD patient population that had access to a 24/7 NN-led helpline to a reference population who did not have access to such a service. Data between August 2017 and October 2019 were extracted from patient charts. Distribution of the number of flares and time to clinical assessment between the NN exposed cohort and a non-NN exposed cohort are planned using multivariate analysis. This is a preliminary description of the NN-exposed cohort only. Results Preliminary results identified a total of 643 patients in the NN-exposed cohort. The majority of our NN-exposed population were female (64.3%). The mean age was 46.42 ± 16.86 years. Sixty-five per cent of patients had CD, 33% UC and 2% IBDU. Of the 729 calls extracted, care coordination (39%) was the most frequent indication for calls followed by flare (25%), and medication education (16%). Patients made the majority (52.8%) of calls compared with NN initiated calls (47.2%). The mean number of calls per patient was 2.64 ± 2.51 (range 1–18) during the study period. Time to clinic assessment post flare call was on average 10.22 ± 8.51 days. Conclusion These results are descriptive of the NN-exposed cohort. Data comparing outcomes amongst the NN-exposed cohort to the non-exposed cohort will be presented at ECCO.

scholarly journals P389 Post induction infliximab trough levels predict long-term endoscopic remission in paediatric patients with inflammatory bowel disease

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S362-S363
Author(s):  
K van Hoeve ◽  
E Dreesen ◽  
I Hoffman ◽  
M Ferrante ◽  
S Vermeire
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Drug Exposure ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Endoscopic Remission ◽  
Inflammatory Bowel ◽  
Trough Levels

Abstract Background Although higher infliximab (IFX) trough levels (TL) have been associated with better outcomes, the ideal predictive sampling time and cut-points to achieve endoscopic remission remain unclear in children with inflammatory bowel disease (IBD). Therefore, we evaluated the pharmacokinetics of IFX during induction to predict long-term outcome of IFX. Methods All children with Crohn’s disease (CD) or ulcerative colitis (UC) starting IFX therapy (5 mg/kg at weeks 0–2–6–12) for active luminal disease from May 2017 till May 2019 were followed prospectively. IFX levels were measured by Ridascreen IFX Monitoring ELISA (TL at weeks 2–6–12, peak at weeks 0–2–6 and intermediate at weeks 1–4). IFX levels and cumulative drug exposure (area under the curve (AUC) till week 12) were correlated with the outcome at month 6. Clinical remission was defined as PUCAI/PCDAI <10, biochemical remission as CRP ≤5 mg/l + ESR ≤20 mm/h, endoscopic remission as SES-CD <3 or Mayo endoscopic sub-score = 0 and deep remission if both clinical + endoscopic remission. Results were analysed using Mann–Whitney U-test (presented as median [IQR]). Results A total of 252 serum induction levels were included from 32 patients (20 CD and 12 UC; 38% male; median age at start of IFX 13.8 years [11.3–14.9]; 84% on concomitant thiopurines). Clinical remission was achieved in 24 (75%) patients and 18 (56%) were in endoscopic remission (all in deep remission) at month 6. Endoscopic remission at month 6 was associated with significantly higher median IFX TL at week 4 (38.8 µg/ml [24.3–46.0] vs. 23.5 µg/ml [10.5–36.6], p = 0.017), at week 6 (19.9 µg/ml [10.1–26.3] vs. 11.1 µg/ml [3.7–19.9], p = 0.031), at week 12 (9.6 µg/ml [5.5–11.9] vs. 3.5 µg/ml [2.7–7.2], p = 0.004; fig1.) and higher AUC week 0–12 (4574.7 µg*day/ml [3783.0–5160.8] vs. 3722.9 µg*day/ml [3102.2–3991.9], p = 0.008). Median IFX TL at week 12 were significantly higher in children with clinical remission (8.6 µg/ml [5.1–12.0] vs. 4.3 µg/ml [3.1–5.9], p = 0.033), but not for biological remission (6.7 µg/ml [4.0–12.0] vs. 4.3 µg/ml [1.2–7.2], p = 0.250; Figure 2) at month 6. ROC analysis identified an IFX TL at week 12 ≥ 5.0 µg/ml and an AUC weeks 0–12 ≥ 4056.0 µg*day/ml as minimal target to achieve endoscopic remission at mo. 6 (AUROC: 0.796 [95% CI: 0.62–0.97] and AUROC: 0.778 [95% CI: 0.61–0.94], respectively; Figure 3.). Height, haemoglobin and PCDAI score at start of IFX therapy, significantly correlated with week 12 IFX TL. Conclusion Adequate IFX exposure during induction in paediatric IBD patients is associated with significantly better clinical, endoscopic and deep remission rates at month 6. Model-informed precision dosing can assist physicians to achieve optimal exposure during induction more precisely (and rapidly) what is essential for an optimal outcome.

scholarly journals Relationship between Serum Adalimumab Levels and Clinical Outcome in the Treatment of Inflammatory Bowel Disease

2019 ◽  
Vol 37 (6) ◽  
pp. 444-450 ◽  
Author(s):  
Joaquín Hinojosa ◽  
Fernando Muñoz ◽  
Gregorio Juan Martínez-Romero
Keyword(s):  
Inflammatory Bowel Disease ◽  
Clinical Outcome ◽  
Maintenance Therapy ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Meta Analysis ◽  
Serum Levels ◽  
Mucosal Healing ◽  
Endoscopic Remission ◽  
Inflammatory Bowel

Background: Adalimumab (ADA) is an anti-tumor necrosis factor agent that has been shown to be effective in inducing and maintaining remission in adult patients with inflammatory bowel disease. The relationship between the ADA trough levels and clinical efficacy has been demonstrated, but there is variability in the definition of the most suitable range for its clinical applicability. Summary: A review of published studies during the last 5 years on ADA serum levels and its relationship with the clinical outcome was performed. The studies selected included 7 observational studies, a systematic review, a meta-analysis and a post hoc analysis of a clinical trial. The reported ADA levels that discriminate patients in clinical remission from those with active disease range from 4.5 to 8 µg/mL. This therapeutic range varies when considering endoscopic remission (7.5 to >13.9 µg/mL). Although the sample of patients with ulcerative colitis is small, a tendency to reach higher levels of ADA is observed in both clinical and endoscopic remission. Key Messages: The optimal therapeutic cut-off point of serum ADA levels ranges from 4.5–5 to 12 µg/mL, where ADA levels are associated with an adequate clinical monitoring of the disease during maintenance therapy. These ranges vary according to the target, suggesting levels of 4.8 µg/mL as the cut-off for clinical remission and levels ≥7.5 µg/mL for mucosal healing/endoscopic response. Controlled prospective studies are required to determine the optimal therapeutic interval of ADA serum levels both as induction and as maintenance therapy.

scholarly journals P552 Withdrawal of immunomodulator medications (IM) in children with inflammatory bowel disease on combination therapy of IM and biologics

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S468-S470
Author(s):  
A Chandrakumar ◽  
M Carroll ◽  
J deBruyn ◽  
K Jacobson ◽  
H Huynh ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Combination Therapy ◽  
Median Duration ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Factors Associated ◽  
Pediatric Study ◽  
First Relapse ◽  
Inflammatory Bowel

Abstract Background Anti-tumor necrosis factor (anti-TNF) antagonists such as infliximab (IFX) are widely used for the treatment of inflammatory bowel disease (IBD). Early studies suggested that combination therapy with IFX and an immunomodulator drug (IM) such as azathioprine (AZA) or methotrexate (MTX) may help in optimising biologic pharmacokinetics, minimising immunogenicity, and improving outcomes. On the other hand, IM especially AZA, may increase infection and cancer risks with no clear evidence on long-term benefits of combination therapy. As such, stopping IM and continuation of an anti-TNF agent as a monotherapy in patients in remission seem to be a sensible strategy. However, there is no evidence to prove the efficacy of this strategy. The aim of this work was to examine frequency and factors associated with the first relapse after IM withdrawal in a cohort of children with IBD on combination therapy. Methods In a retrospective multicenter pediatric study, we determined the percentage of patients and investigated potential factors associated with the first relapse in a cohort of children and young adults with IBD on combination therapy of anti-TNF and IM after stopping IM. Cox regression analysis was used to assess factors associated with IBD relapse following IM withdrawal. Results A total of 79 patients (42, males, 62 Crohn’s disease) with 74 (93.7%) on IFX were included. In addition to the anti-TNF agent, 33 (41.8%) were on AZA and the rest were on MTX. The median duration of combination therapy was 2.0 (IQR 1.2–2.8) years. All participants were in clinical remission at the time of IM withdrawal. The median duration of follow-up after IM withdrawal was 11.0 (IQR 5.0–16.2) months. Only 8 (10.1%) patients relapsed over that period of follow-up. Age, sex, disease phenotype at diagnosis, family history of IBD, type of IM, and biochemical markers and clinical disease activity indices prior to IM stoppage did not predict a future relapse. Among those with CD on IFX who maintained remission, the median last IFX trough level before IM withdrawal was 6.25 Ug/ml (IQR: 4.04–8.70) vs. 3.8 Ug/ml (IQR: 2.40–11.6) in those who relapsed (p = 0.4). Conclusion Over short-term follow-up, the majority of children on combination therapy of IM and an anti-TNF agent remain in clinical remission after IM withdrawal.

scholarly journals P580 Irritable bowel syndrome in inflammatory bowel disease after remission: correlation with remission patterns and inflammation

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S487-S488
Author(s):  
O Sezgin ◽  
B Boztepe ◽  
E Altintas ◽  
D Çelikcan
Keyword(s):  
Inflammatory Bowel Disease ◽  
Irritable Bowel Syndrome ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Inflammation Markers ◽  
Biopsy Specimens ◽  
Endoscopic Remission ◽  
Rome Iii ◽  
Inflammatory Bowel ◽  
Irritable Bowel

Abstract Background The objective of the study is to establish the frequency of irritable bowel syndrome (IBS) in patients with inflammatory bowel disease in clinical and deep remission and correlation with inflammation markers. Methods In this study, patients with ulcerative colitis (UC), and with Crohn disease (CD) in clinical remission for at least 6 months enrolled. All of the patients underwent colonoscopy and biopsy specimens were taken to evaluate endoscopic and histopathologic remission. All of the cases were given a questionnaire using the Rome III criteria for IBS and faecal specimens for calprotectin analysis, and blood samples for CRP, sedimentation rate and fibrinogen levels were taken. Results IBS frequency was 20.9% in UC cases in clinical remission, 28.9% in CD cases, and did not vary by the presence or absence of endoscopic remission (20,5% vs.22,2% in UC, p:0,727, 25% vs.33,3% in CD, p:0,837) or histopathologic remission (15,7% vs.26,6% in UC, p:0,723, 21,4% vs.33,3% in CD respectively, p:0,999). The incidence of IBS did not change statistically with deepening of remission in both diseases. It was not related to inflammation markers Conclusion IBS frequency among IBD patients in clinical remission was 21–29% and did not vary by the presence or absence of endoscopic or histopathologic remission or by inflammation markers levels. This suggests that IBS may not be related to ongoing subclinical inflammation in IBD in remission.

Safety of Hydrocortisone Premedication Discontinuation in Patients with Inflammatory Bowel Disease on Maintenance Therapy with Infliximab: a Prospective Clinical and Pharmacological Study

2020 ◽  
Author(s):  
My-Linh Tran-Minh ◽  
Jean-Marc Gornet ◽  
Marianne Maillet ◽  
Pascal Houze ◽  
Marion Simon ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Combination Therapy ◽  
Maintenance Therapy ◽  
Clinical Response ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Pharmacological Study ◽  
Infusion Reaction ◽  
Tertiary Referral Centre ◽  
Inflammatory Bowel

Abstract Background Hydrocortisone premedication reduces the risk of antibodies to infliximab [ATIs] formation in patients receiving infliximab [IFX] therapy for inflammatory bowel disease [IBD]. Aim We aimed to determine the safety of hydrocortisone premedication withdrawal in IBD patients with sustained clinical response on maintenance therapy with IFX. Methods We performed an observational prospective pharmacoclinical study in a tertiary referral centre, including all consecutive IBD outpatients with no previous IFX infusion reaction and in clinical remission on maintenance IFX [alone or in combination therapy] for at least 6 months. This cohort was followed for 1 year after discontinuation of hydrocortisone premedication. Results Among the 268 IBD outpatients, 95 patients met the inclusion criteria [mean age 38 years; 64% male; 80% Crohn’s disease; 45% combination therapy]. The median IFX duration was 5 years [0.54–14] with a mean infused dose of 533 mg [200–1000] and a mean interval duration of 7.9 weeks [4–10]. None of the patients developed permanent ATIs or infusion-related reaction at 1 year. Four patients developed transient ATIs without loss of clinical response. There was no significant variation of infliximab serum trough levels [5.5 µg/mL vs 5.9 µg/mL] measured at the time of the three IFX infusions before and after hydrocortisone withdrawal. Loss of response rate to IFX was 18% at 1 year. Conclusions Hydrocortisone discontinuation is safe in IBD patients with sustained clinical remission on maintenance therapy with IFX. Our data suggest that routine premedication with hydrocortisone is unnecessary in patients in prolonged remission under IFX maintenance therapy.

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