P224 Relationship of faecal calprotectin and long-term outcomes in Finnish adult patients with Crohn’s disease: Retrospective multi-centre chart review study

Abstract Background There is a paucity of data regarding long-term outcomes for adalimumab (ADA) in pediatric Crohn’s disease (CD). We describe the long-term effectiveness of ADA, in achieving clinical and biochemical remission in a Canadian multi-centre pediatric CD cohort. Moreover, we report the effects of prior anti-TNF exposure and use of a concomitant immunomodulator (IM) on durability of clinical and biochemical response. The primary outcome was 24-month corticosteroid (CS) free remission. Secondary objectives included biochemical and faecal calprotectin response over the study period. Methods Retrospective review of electronic records of all children aged 3–18 years with CD requiring ADA at 4 centres across Canada (Vancouver, Edmonton, Winnipeg and Calgary) between January 2005 and December 2017. Results One hundred and nine children (68% male; median age 13.07 [IQR 10.6–15.1]) with CD (L1 21.7%, L2 28.3%, L3 50%) were included with a median follow-up of 15.9 months [IQR 7.6–24]. Seventy-four patients (67.9%) were anti-tumour necrosis factor (TNF) naïve. Concomitant IM therapy was used in 51 (46.8%). CS free clinical remission at 24 months was observed in 45/66 (68%). Over time, the median PCDAI, CRP, ESR and faecal calprotectin significantly improved (Table 1). During follow-up, 36 (33%) patients discontinued ADA; 6 (5.5%) had primary non-response, 28 (25.7%) had secondary LOR and 2 (1.8%) had intolerance. At 24 months, clinical remission was achieved more frequently in patients who were Anti-TNF naïve (81% vs. 43.5% p 0.002). There was no significant difference in biochemical or faecal calprotectin outcomes between those who were bio-naive or experienced. There was no significant difference in the time to loss of response between those on monotherapy and combination therapy with an IM and ADA (HR 0.64 [95% CI 0.33–1.26] p0.2). Conclusion This study demonstrates that ADA is effective and durable in pediatric CD. Over 24 months, clinical, biochemical and faecal calprotectin improvement was seen. In our cohort, clinical response to ADA was greater in anti-TNF naïve compared with anti-TNF experienced patients; however,, biochemical and faecal calprotectin outcomes did not differ. ADA response appears durable with no significant difference in patients on monotherapy or combination therapy.

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DOP57 Predictive modelling to examine long term treatment effectiveness of darvadstrocel in patients with complex perianal fistulas in Crohn’s Disease

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab073.096 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S092-S093

Author(s):

M Maruszczak ◽

K Genenz ◽

E Turkstra ◽

E Fenu ◽

G Hantsbarger ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Chart Review ◽

Predictive Modelling ◽

Perianal Fistulas ◽

Number Of Patients ◽

Long Term Treatment ◽

Review Study

Abstract Background Darvadstrocel (DVS) was approved in 2018 by EMA for treatment of complex perianal fistulas in Crohn’s disease (CPF-CD)1, with evidence on long-term effectiveness still accruing. The objective of this study was to synthesize clinical trial data and real-world evidence (RWE) using robust statistical methodologies to predict absolute and relative long-term effectiveness of DVS vs. standard of care (SoC) in patients with CPF-CD. Methods Data was pooled from the pivotal phase 3 trial ADMIRE-CD (n=212; ≤ 2 years data), INSPECT (n=89; chart review study of patients completing ≥52 weeks in ADMIRE-CD, 2-year follow-up post-trial) and PREFACE (n=313; chart review study of patients undergoing SoC treatment, median follow-up of 4 years). Individual anonymized patient data from these studies were combined and analysed with shared covariates of interest included in regression analyses. Weighting procedures were used to adjust for bias due to differences in distribution of outcomes among patients included in INSPECT. Key outcomes were clinical remission, clinical and patient-centric remission (CPC remission), and relapse. Missing values were imputed using a multi-level Bayesian approach. Predictive statistical models extrapolated clinical outcomes beyond the observed follow-up time using parametric curves which were fitted to the defined study populations for each treatment arm and outcome. The models were then implemented within a semi-Markov model, to obtain the resultant number of patients in remission. Results Adult patients with CPF-CD from ADMIRE-CD and PREFACE were similar in age, number of internal and external openings of the perianal fistulas. However, the median CD disease duration was 9.5 vs 6.5 years and prior biologic exposure: 79.5% vs 46.0% for patients in ADMIRE-CD and PREFACE respectively. Patients included in INSPECT were comparable to the overall ADMIRE-CD patients for the covariates of interest. Percentage of patients in CPC remission at 24 months was 39% vs 32% for DVS and SoC respectively for ADMIRE-CD+INSPECT. However, after adding PREFACE data to the predictive model and adjusting for outcome bias, the predicted percentage of patients in CPC remission increased in DVS and SoC groups to 48% vs 35%, respectively. There were small differences by 48 months, after which the remission rates stabilized (Figure). Conclusion In this pooled analysis, we used predictive modelling to examine the effectiveness of DVS vs. SoC over a longer time. Inclusion of RWE to the model indicates possible maintenance of the disease-modifying effect of DVS over a longer time period. Reference 1. Panés et al. Gastroenterology 2018;154:1334–42 Sponsor: Takeda Pharmaceuticals USA, Inc.

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Long-Term Outcomes of Infliximab Treatment in 582 Korean Patients with Crohn’s Disease: A Hospital-Based Cohort Study

Digestive Diseases and Sciences ◽

10.1007/s10620-016-4105-6 ◽

2016 ◽

Vol 61 (7) ◽

pp. 2060-2067 ◽

Cited By ~ 10

Author(s):

Sang Hyoung Park ◽

Sung Wook Hwang ◽

Min Seob Kwak ◽

Wan Soo Kim ◽

Jeong-Mi Lee ◽

...

Keyword(s):

Cohort Study ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Infliximab Treatment ◽

Long Term Outcomes ◽

Korean Patients

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P173 Predictors of long-term outcomes of perianal fistulizing Crohn's disease

Journal of Crohn s and Colitis ◽

10.1016/s1873-9946(13)60195-6 ◽

2013 ◽

Vol 7 ◽

pp. S78

Author(s):

B. Tchoundjeu ◽

T. Rohou ◽

G. Bouguen ◽

D. Cuen ◽

T. Wallenhorst ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Long Term Outcomes

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Long-term Outcomes Following Continent Ileostomy Creation in Patients With Crohn’s Disease

Diseases of the Colon & Rectum ◽

10.1097/dcr.0000000000000816 ◽

2017 ◽

Vol 60 (5) ◽

pp. 457-458 ◽

Cited By ~ 2

Author(s):

Robert W. Beart

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Continent Ileostomy ◽

Long Term Outcomes

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Long‐term outcomes of perianal fistulizing Crohn's disease in the biologic era

JGH Open ◽

10.1002/jgh3.12475 ◽

2020 ◽

Author(s):

Tanya Lee ◽

Michael A Kamm ◽

Sally Bell ◽

Mark Lust ◽

Steve Brown ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Long Term Outcomes

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Long-term outcomes after elective ileocecal resection in children with active localized Crohn's disease—a multicenter European study

Journal of Pediatric Surgery ◽

10.1016/j.jpedsurg.2015.03.054 ◽

2015 ◽

Vol 50 (10) ◽

pp. 1630-1635 ◽

Cited By ~ 8

Author(s):

Iva Hojsak ◽

Sanja Kolacek ◽

Lars Folmer Hansen ◽

Jiri Bronsky ◽

Maija Piekkala ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Ileocecal Resection ◽

European Study ◽

Long Term Outcomes

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Systematic Analysis of the Impact of Diagnostic Delay on Bowel Damage in Paediatric Versus Adult Onset Crohn’s Disease

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz065 ◽

2019 ◽

Vol 13 (10) ◽

pp. 1334-1342 ◽

Cited By ~ 10

Author(s):

Alain Schoepfer ◽

Jessica Santos ◽

Nicolas Fournier ◽

Susanne Schibli ◽

Johannes Spalinger ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Diagnostic Delay ◽

Perianal Fistula ◽

Adult Patients ◽

Adult Onset ◽

Systematic Analysis ◽

Internal Fistula ◽

The Impact

Abstract Background and Aims Length of diagnostic delay is associated with bowel strictures and intestinal surgery in adult patients with Crohn’s disease [CD]. Here we assessed whether diagnostic delay similarly impacts on the natural history of paediatric CD patients. Methods Data from the Swiss IBD Cohort Study were analysed. Frequency of CD-related complications [bowel stenosis, perianal fistula, internal fistula, any fistula, resection surgery, fistula/abscess surgery, any complication] at diagnosis and in the long term [up to 30 years after CD diagnosis] was compared between paediatric patients [diagnosed <18 years] and adult patients [diagnosed ≥18 years] using multivariate Cox proportional hazard regression modelling. Results From 2006 to 2016, 387 paediatric and 1163 adult CD patients were included. Median [interquartile range: IQR] diagnostic delay was 3 [1–9] for the paediatric and 6 [1–24] months for the adult group, respectively. Adult onset CD patients presented at diagnosis more frequently with bowel stenosis [p <0.001] and bowel surgery [p <0.001] compared with paediatric CD patients. In the long term, length of diagnostic delay was significantly associated with bowel stenosis [p = 0.001], internal fistula [p = 0.038], and any complication [p = 0.024] in the adult onset CD population. No significant association between length of diagnostic delay and CD-related outcomes in the long term was observed in the paediatric population. Conclusions Adult CD patients have longer diagnostic delay compared with paediatric CD patients and present at diagnosis more often with bowel stenosis and surgery. Length of diagnostic delay was found to be predictive for CD-related complications only in the adult but not in the paediatric CD population.

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