scholarly journals P622 Comparison of midterm outcomes in Pediatric Crohn’s Disease patients treated with either Exclusive Enteral Nutrition or Corticosteroids around disease diagnosis– a population based study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S562-S562
Author(s):  
L Plotkin ◽  
G Focht ◽  
S Harel ◽  
I Dotan ◽  
S Greenfeld ◽  
...  

Abstract Background Corticosteroids (CS) and exclusive enteral nutrition (EEN) are commonly used as induction therapy in pediatric Crohn’s disease (PCD). Pediatric studies showed that CS treatment is equivalent to EEN for induction of remission, and it is easier to tolerate. However, EEN may be associated with superior long-term outcomes but this remains controversial. We thus aimed in this population-based study to compare CS dependency rate in children receiving EEN vs CS as induction therapy at the time of diagnosis, and to explore additional outcomes after one and two years of follow-up: IBD-related surgery, hospitalizations, and the use of biologics. Methods This study was performed on data from two Israeli Health Maintenance Organizations (HMOs), covering 78% of the population. We included all PCD patients (<18 years) diagnosed between 2005 and 2017 treated with EEN or CS within the first six months of diagnosis, with at least one-year follow-up. We excluded patients who initiated biologics within the same quarter. CS dependency was defined as a systemic steroid course lasting >90 days or four purchases with 12 months. Results A total of 2,730 PCD were identified, of whom 669 (24.5%) received induction therapy with either EEN [n=227 (8.3%)] or CS ([n=442 (16.2%)]. Median age at diagnosis was 13.04 years (3.8). Baseline (BL) characteristics, including age at diagnosis, anthropometrics data and gender, were similar between the groups. Steroid dependency was higher in the CS group compared to the EEN group during the 1st and the 2nd year (10% vs. 7%, p<0.001 and 14% vs. 12%, p<0.001 respectively). Use of biologics was higher in the 1st but not the 2nd year in the EEN group compared to the CS group (28% vs. 19%, p=0.0016 and 40% vs. 33%, p=0.066 respectively). Hospitalization rate was higher in the CS group in both the 1st and 2nd years (42% vs. 22%, p<0.001 and 51% vs. 30%, p<0.001 respectively). There were no differences between the groups in surgeries rate and growth during the 1st and 2nd year follow-ups. Conclusion The use of CS as induction therapy in PCD was associated with a higher corticosteroid dependency rate, as well as more hospitalizations during the first two years of follow-up.

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S505-S508
Author(s):  
P Kakkadasam Ramaswamy ◽  
R Mutsekwa ◽  
X Lan ◽  
Y Chen ◽  
R Angus ◽  
...  

Abstract Background Exclusive Enteral nutrition (EEN) is not routinely used as induction therapy for adults with active Crohn’s disease (CD)due to limited adherence and palatability. The aim of this study was to assess the efficacy, tolerability and safety of EEN in adult patients with CD. Methods Retrospective analysis of data from patients with active CD who underwent induction therapy with EEN at a single centre from January 2018 to July 2019. All patients who completed at least 4 weeks of polymeric EEN diet were included in the final analysis. Primary Endpoint (PE) was steroid-free clinical remission (CDAI ≤150) or response (100 point decrease in CDAI) at the end of therapy. Secondary endpoint (SE) was achievement of biochemical remission (CRP <5 mg/l or Calprotectin <150 μg/g) at 8–10 weeks. Results Sixty-three patients were initiated on EEN, 50 patients who completed at least 4 weeks of EEN were included in the final analysis. Mean age was 42.4 years, 25 (50%) were females. Mean CDAI score at baseline was 260. Forty per cent of patients were on concurrent biologics and 66.6% were on concurrent immunomodulators. At the completion of EEN, 72% (36/50) of patients achieved PE (29 remission, 7 response). SE was achieved in 65.7% (23/35) of patients. EEN duration ≥ 6 weeks was more likely to achieve PE (75% vs. 55.5%, OR 2.7, P 0.01) and SE (71% vs. 25%, OR 7.3, P 0.001).EEN duration < 6 weeks and current smoking were less likely to achieve PE and SE. Patients with concomitant steroid use at baseline had PE of 77.7% (vs. 68.8% with EEN alone; OR 0.9, P 0.5), and SE of 66.6% (vs. 60.9% with EEN alone, OR 0.77, P 0.74). Disease location, behaviour, sex, disease duration, concurrent biologic use or concurrent immunomodulator use did not affect the PE or SE. Six patients reported adverse effects (3 nausea,2 diarrhoea,1 constipation). Male sex, ileal location, B2/B3 phenotype were more likely to complete a 6 week EEN course. Conclusion Polymeric EEN is well-tolerated, safe and efficacious in inducing remission in adults with active CD. EEN duration of ≥ 6 weeks has better outcomes. EEN alone or in combination with steroids induces remission in adult patients with active CD. Further controlled trials using polymeric EEN are necessary.


2021 ◽  
Vol 10 (23) ◽  
pp. 5613
Author(s):  
Roma Herman ◽  
Paulina Dumnicka ◽  
Stanisław Pieczarkowski ◽  
Krzysztof Fyderek

Mucosal healing (MH) is the main therapeutic goal of Crohn’s disease (CD). The Mucosal Inflammation Noninvasive Index (MINI) appears to be a promising tool for distinguishing MH from its inflammation. This study aims to evaluate MINI in monitoring remissions induced by exclusive enteral nutrition (EEN) in pediatric CD patients. Out of 55 newly diagnosed CD children, 31 who completed 6–8 weeks of EEN were analyzed. Clinical and biochemical data, activity of CD assessed with the Pediatric Crohn’s Disease Activity Index (PCDAI) and MINI were compared within seven days pre- and post-EEN. Response to induction therapy was defined as a decrease of PCDAI by >12.5 points. The follow-up was performed up to 12 months after EEN termination. Out of 31 children who completed 6–8 weeks of EEN, eight required corticosteroids in addition to EEN. Twenty-four patients (77%) responded to induction therapy. In responders, MINI decreased from 19 (Q1:17; Q3:22) to 12 (Q1:6; Q3:14), p < 0.001. The diagnostic accuracy of post-EEN MINI and post-EEN fecal calprotectin (FC) for treatment failure were AUC: 0.899 (95%CI: 0.737–1.000) and 0.762 (95%CI: 0.570–0.954), respectively. In the follow-up of 25 patients (80.6%), the post-EEN MINI of ≥13 points predicted CD relapse (87.5% sensitivity; 64.7% specificity), while FC had no prognostic value. MINI allows for monitoring of EEN and is superior in predicting disease relapse to FC.


2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S517-S517
Author(s):  
G Pujol Muncunill ◽  
A I Pascual-Pérez ◽  
P Dominguez-Sánchez ◽  
S Feo-Ortega ◽  
M Suárez-Galvis ◽  
...  

Abstract Background Several studies have shown the efficacy of Exclusive Enteral Nutrition (EEN) in patients with Crohn’s disease (CD) for the induction of remission. ECCO-ESPGHAN guidelines recommend the use of EEN combined with early use of immunosuppressants in paediatric patients with mild-to-moderate CD. However, there is a lack of data to show its efficacy in the long term to avoid or postpone the use of biological treatment. The aim of our study is to know how many of our patients that have achieved remission with EEN and Azathioprine (AZA), required to step up to biological treatment during the follow-up. Methods Retrospective analysis of paediatric patients with Crohn’s disease that were diagnosed at our Unit between 2003 and 2017. We included those patients that achieved clinical remission after treatment with EEN and AZA. We analyse demographics, clinical and follow-up data until February 2019 or until they are transferred to an adult inflammatory bowel disease (IBD) unit. Results We included 91 patients that achieved clinical remission after treatment with EEN and AZA (68.1% males; Mean age at diagnosis: 12.29 years; Median age at diagnosis: 13 years (range 8 months-17 years). The mean time of follow-up was 60.45 months (range: 8–165 months). During this period, 66/91 patients (72.5%), had a flare. Seventeen of those patients (20.2%) received a second cycle of EEN, being effective in 7 (41.2%). Mean time from diagnosis until the second cycle of EEN was 13.76 months (maximum: 110 months). Globally, 64.8% of our patients required to step up to biological therapy with a mean time from onset to biologics of 15.3 months (median 9 months). Seventy-two per cent of those who needed biological treatment started Adalimumab (ADA). During the follow-up, 42.2% of the patients with combo therapy could withdraw AZA, being the main reason (76.3%) clinical and endoscopic remission. Conclusion Even though EEN is an effective treatment for the induction of the remission in paediatric CD, in the long term we are not able to maintain that remission and an important percentage of patients require to step up to biological therapy. The definition of more strict criteria of remission is necessary in order to establish the most suitable maintenance treatment for each patient.


Author(s):  
Åsa H Everhov ◽  
Thordis Disa Kalman ◽  
Jonas Söderling ◽  
Caroline Nordenvall ◽  
Jonas Halfvarson ◽  
...  

Abstract Background Surgery rates in patients with Crohn’s disease have decreased during the last few decades, and use of antitumor necrosis agents (anti-TNF) has increased. Whether these changes correlate with a decreased probability of stoma is unknown. The objective of this study was to investigate the incidence of stoma in patients with Crohn’s disease over time. Methods Through linkage of national registers, we identified patients who were diagnosed with Crohn’s disease in 2003–2014 and were followed through 2019. We compared formation and closure of stomas over the calendar periods of diagnosis (2003–2006, 2007–2010, and 2011–2014). Results In a nationwide cohort of 18,815 incident patients with a minimum 5 years of follow-up, 652 (3.5%) underwent formation of a stoma. This was mostly performed in conjunction with ileocolic resection (39%). The 5-year cumulative incidence of stoma formation was 2.5%, with no differences between calendar periods (P = .61). Less than half of the patients (44%) had their stoma reversed. Stomas were more common in elderly-onset compared with pediatric-onset disease: 5-year cumulative incidence 3.6% vs 1.3%. Ileostomies were most common (64%), and 24.5% of the patients who underwent stoma surgery had perianal disease at end of follow-up. Within 5 years of diagnosis, 0.8% of the incident patients had a permanent stoma, and 0.05% had undergone proctectomy. The time from diagnosis to start of anti-TNF treatment decreased over calendar periods (P &lt; .001). Conclusions Despite increasing use of anti-TNF and a low rate of proctectomy, the cumulative incidence of stoma formation within 5 years of Crohn’s disease diagnosis has not decreased from 2003 to 2019.


2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S374-S374
Author(s):  
Y S Jung ◽  
M Han ◽  
S Park ◽  
J H Cheon

Abstract Background Data on the comparative effectiveness of infliximab (IFX) or adalimumab (ADA) in patients with Crohn’s disease (CD) are rare, particularly for Asian patients. We compared the clinically key outcomes (surgery, hospitalisation, and corticosteroid use) of these two drugs in biologic-naive Korean patients with CD. Methods Using National Health Insurance claims, we collected data on patients who were diagnosed with CD and exposed to IFX or ADA between 2010 and 2016. Results We included 1488 new users of biologics (1000 IFX users and 488 ADA users). Over a median follow-up of 2.1 years after starting biological therapy, there were no significant differences in the risk of surgery (ADA vs. IFX; adjusted hazard ratio [aHR], 1.30; 95% confidence interval [CI], 0.86–1.95), hospitalisation (aHR, 1.05; 95% CI, 0.84–1.32), and corticosteroid use (aHR, 0.84; 95% CI, 0.58–1.22) between IFX and ADA users. These results were unchanged even when only patients who used biologics for over 6 months were analysed (aHR [95% CI]; surgery: 1.41 [0.88–2.26], hospitalisation: 1.06 [0.83–1.35], and corticosteroid use: 0.82 [0.56–1.21]). Additionally, these results were stable in patients treated with biological monotherapy or combination therapy with immunomodulators. Conclusion In this nationwide population-based study, there was no significant difference in the long-term effectiveness of IFX and ADA in the real-world setting of biologic-naive Korean patients with CD. In the absence of trials to directly compare IFX and ADA, our study supports that the choice of one of these two biologics may be allowed to be determined by the preference of patients and/or physicians.


2001 ◽  
Vol 120 (5) ◽  
pp. A628-A628
Author(s):  
E LOFTUSJR ◽  
C CROWSON ◽  
W SANDBORN ◽  
W TREAMINE ◽  
W OFALLON ◽  
...  

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