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

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Abstract

Background Fecal calprotectin (fCal) has been shown to correlate well with endoscopic healing in Crohn’s disease (CD) patients, while less evidence is available on the association of fCal and long-term outcomes such as the need for surgeries. This study was established to analyse whether the surgery free survival (SFS) is associated with the attained fCal-levels 12 months after biological therapy initiation. In addition, the association of fCal-levels at 12 months and composite event free survival (CEFS) was assessed. The composite event was defined as surgical procedure, corticosteroid initiation, treatment failure, or dose increase occurring after the 12-month fCal-measurement. Methods A non-interventional, retrospective patient chart review study was carried out in 4 major Finnish gastroenterology clinics (EUPAS17190 registration). The study included adults (age≥18 years) with confirmed CD diagnosis, who had initiated a biologic therapy for CD at any time between January 1st 2010 and June 30th 2016 (n = 186). Results At the start of follow-up, the patients were on average 44 years old and 49% of them were female. Most of the patients had ileocolonic, non-stricturing/non-penetrating CD. At baseline the mean fCal was 958 mg/g (n = 62) and at 12-months it was 558 mg/g. The mean follow-up time was 1119 days (range 562–1774). CRP, thrombocytes and albumin levels had strong and significant associations with fCal when measured at similar timepoints. The SFS analysis included 4 failures (i.e. surgical procedures) with the mean of 741 days at risk per patient. fCal (mg/g) at 12 months and ileocolonic CD were significant predictors for SFS. The CEFS analysis included 22 failures with the mean of 572 days at risk per patient. fCal (mg/g) at 12 months was the only significant and robust predictor for CEFS in univariate (HR 1.0005, 95% CI 1.0002 – 1.0008, p = 0.003) and multivariate models. Conclusions Among the CD patients, fCal was a robust predictor of composite outcome measured as surgical procedure, corticosteroid initiation, treatment failure or dose increase. fCal was also associated with surgery-free survival.
Abstracts of the 13th Congress of ECCO – European Crohn’s and Colitis Organisation S213
responded to steroids, 24 patients (40%) were non-responders. 3
(12.5%) non-responders received iniximab as second line therapy,
1 (4.2%) adalimumab and 20 (83.3%) ciclosporin; 11 (45.8%) non-
responders required surgery, 100% of whom had been previously
treated with ciclosporin. On univariate analysis, the albumin, plate-
let count and CRP differed signicantly between responders and
non-responders (p = <0.05), whereas on multivariate analysis only
CRP and albumin were signicant. No difference was seen for hae-
moglobin and stool frequency. 88.9% of patients with concurrent
hypoalbuminaemia, high CRP and high platelets (score= 3) were
non-responders.
Table1. Day one results
Figure1. Patient scoring, based on CRP, albumin and platelet results
Table 2. Score based on CRP, albumin and platelet results. Total = [CRP
>50mg/dL (0 or 1)] + [albumin < 30g/l (0 or 1)] + [platelets >450 x 109/l (0 or
1)]. Minimum score=0; maximum score=3
Conclusions: 82.4% of patients with a score of 2 or more will fail
rst-line medical therapy. The combination of these readily available
parameters identies a high-risk population who may benet from
earlier second line medical or surgical intervention.
P224
Relationship of faecal calprotectin and long-term
outcomes in Finnish adult patients with Crohn’s
disease: Retrospective multi-centre chart review
study
T.Hallinen1, A.Jussila2, C.-G.af Björkesten3, H.Kemppainen4, E.Soini1,
P. Mankinen1, S.Valgarðsson5, V. Veckman6, R.Nissinen6, P. Molander7*
1ESiOR Oy, Kuopio, Finland, 2Tampere University Hospital,
Tampere, Finland, 3Jorvi Hospital, Espoo, Finland, 4Turku University
Hospital, Turku, Finland, 5Janssen-Cilag AS, Oslo, Norway, 6Janssen-
Cilag Oy, Espoo, Finland, 7Peijas Hospital, Vantaa, Finland
Background: Fecal calprotectin (fCal) has been shown to correlate
well with endoscopic healing in Crohn’s disease (CD) patients, while
less evidence is available on the association of fCal and long-term
outcomes such as the need for surgeries. This study was established
to analyse whether the surgery free survival (SFS) is associated with
the attained fCal-levels 12 months after biological therapy initia-
tion. In addition, the association of fCal-levels at 12months and
composite event free survival (CEFS) was assessed. The composite
event was dened as surgical procedure, corticosteroid initiation,
treatment failure, or dose increase occurring after the 12-month
fCal-measurement.
Methods: A non-interventional, retrospective patient chart review
study was carried out in 4 major Finnish gastroenterology clinics
(EUPAS17190 registration). The study included adults (age≥18years)
with conrmed CD diagnosis, who had initiated a biologic therapy
for CD at any time between January 1st 2010 and June 30th 2016
(n=186).
Results: At the start of follow-up, the patients were on average
44years old and 49% of them were female. Most of the patients
had ileocolonic, non-stricturing/non-penetrating CD. At baseline the
mean fCal was 958mg/g (n=62) and at 12-months it was 558mg/g.
The mean follow-up time was 1119days (range 562–1774). CRP,
thrombocytes and albumin levels had strong and signicant asso-
ciations with fCal when measured at similar timepoints. The SFS
analysis included 4 failures (i.e. surgical procedures) with the mean
of 741days at risk per patient. fCal (mg/g) at 12months and ile-
ocolonic CD were signicant predictors for SFS. The CEFS analysis
included 22 failures with the mean of 572days at risk per patient.
fCal (mg/g) at 12months was the only signicant and robust predic-
tor for CEFS in univariate (HR 1.0005, 95% CI 1.0002– 1.0008,
p = 0.003) and multivariate models.
Conclusions: Among the CD patients, fCal was a robust predictor of
composite outcome measured as surgical procedure, corticosteroid
initiation, treatment failure or dose increase. fCal was also associ-
ated with surgery-free survival.
P225
Usefulness of monocytosis as biomarker to
predict relapse in inflammatory bowel disease
patients in remission under maintenance
treatment with anti-TNF drugs: Aprospective
longitudinal cohort study
R.Ferreiro, J.Lopez-Diaz, I.Baston, J.E.Dominguez-Munoz,
M.Barreiro-de Acosta
University Hospital Santiago de Compostela, Gastroenterology,
Santiago, Spain
Background: Monocytes play an important role in the pathogenesis
of inammatory bowel disease and recently have been shown to be a
biomarker of activity, but there are no specic data in severe patients
under anti-TNF therapies. The aim of the study was to determine the
value of monocyte measurements in predicting ares in IBD patients
in remission under maintenance treatment with anti-TNF drugs.
Methods: A prospective, observational cohort study was designed.
Inclusion criteria were IBD patients in clinical remission for at least
six months under a continuous standard dose of 40mg/eow adali-
mumab therapy or 5mg/kg iniximab therapy every 8 weeks. Relapse
was dened as a Harvey–Bradshaw score >4 in Crohn’s disease (CD)
and a partial Mayo score>3 in ulcerative colitis (UC). Monocytosis
Downloaded from https://academic.oup.com/ecco-jcc/article-abstract/12/supplement_1/S213/4808511 by guest on 21 February 2020
... When FC was handled as a continuous variable in a previously performed Cox proportional hazard analysis, a statistically significant increase in the expected hazard of surgery as FC increases was observed (HR 1.001176, 95% CI:1.0004-1.0019, p ¼ 0.002) [35]. However, due to the modest number of patients and small number of surgical procedures among the study population, no definitive conclusions could be drawn based on the analysis and further studies are therefore warranted. ...
Article
Full-text available
Background and Aims: A retrospective non-interventional, multi-centre patient chart review study was conducted to investigate the association of faecal calprotectin (FC) 1 year (±2 months) after biological therapy initiation with composite event-free survival (CEFS) consisting of surgical procedures, corticosteroid initiation, treatment failure or dose increase in patients with Crohn’s disease (CD). In addition, the correlations of FC and other tests of disease activity were assessed. Materials and methods: Data on Finnish CD patients initiating a biological therapy between 2010 and 2016, were collected. The association of FC and CEFS was analysed with Kaplan-Meier and Cox proportional hazard modelling. The correlations were tested with Pearson’s test. Results: Biological therapy was initiated in 186 patients, of which 87 (46.8%) had FC results available at 1 year and 80 had follow-up exceeding 14 months. The characteristics of patients with and without FC results were similar. Patients with elevated FC (>250 µg/g) had a significantly increased risk of experiencing composite event (HR 3.4, 95% CI: 1.3–8.9; p = .013) when compared to patients with normal FC (FC ≤ 100). No such risk was observed in patients with intermediately increased FC level (100 µg/g < FC ≤ 250 µg/g) (HR 2.2 (95% CI: 0.8–6.2; p = .120). FC value had significant positive correlation with CRP, HBI and leukocyte values when measured at similar timepoints. Conclusions: Elevated level of FC approximately 1 year after the initiation of biological therapy was associated with an increased risk of either surgical procedures, corticosteroid initiation, treatment failure or dose increase (i.e. composite outcome) in patients with CD.
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