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Abstracts of the 22
nd
National Congress of Digestive Diseases / Digestive and Liver Disease 48S2 (2016) e67–e231
e163
Background and aim:
Crohn’s disease (CD) is a chronic inflammatory
bowel disorder characterized by an alternation of remission and
relapse phases. Even during periods of clinical remission a subclinical
inflammation persists, reflecting a progressive, destructive disease
course in the later phases of the disease. Surgical resection of the
bowel can be considered the ultimate manifestation of bowel
damage. Recently a new score, the Lémann Score (LS), has been
proposed in order to assess the cumulative structural damage to the
bowel in different CD patients. Limited data are present assessing
the value of this instrument in measuring the effect of various
medical therapies on the progression of bowel damage. The aim of
our study was to evaluate the effect of various medical therapies on
the progression of bowel damage using the LS.
Material and methods:
In this retrospective study we included
87 CD patients who were followed up at our IBD Unit. All patients
underwent clinical assessment with measurement of disease
status based on HBI index every tree months, and bowel magnetic
resonance imaging and a colonoscopy every year, or earlier, in case
of disease relapse. Patients were divided on the basis of the drug
administered during the follow-up: i) biological mono-therapy;
ii) azathioprine; iii) mesalazine, and the LS was calculated both at
baseline and at the end of follow-up in each group.
Results:
We included 87 patients (49 males, mean age 43.5 years,
range 19-79) with a median follow-up of 26 months. Among the 35
(40.2%) patients on biological mono-therapy the median LS was 7.1
(range, 2.5-292.3) at baseline and 9.7 (range, 1.3-292.3) at the end
of the follow-up (P=0.34). The median LS in azathioprine group (16
patients, 18.4%) was 3.5 (range, 0.6-159.6) and 7.6 (range, 0.6-209.6)
at baseline and at the end of follow-up, respectively (P=0.0017). In
the mesalazine group (36 patients, 41.4%) the median LS at baseline
and at the end of follow-up was 3.2 (range, 0.6-202.6) and 4.3
(range, 1-206.5), respectively (P<0.0001). As far as the proportion
of patients who showed a worsening in the LS is concerned, the
azathioprine group showed the highest proportion of patients with
increased scores (13/16, 81.3%) followed by the group treated with
mesalazine (20/36, 55.6%), and patients treated with biological
mono-therapy (8/35, 22.9%) (P=0.0002).
Conclusions:
Our data suggest that the use of biological therapy
rather than azathioprine or mesalazine may change the cumulative
structural damage to the bowel and, therefore, is able to modify
disease progression in CD patients, preventing its long-term
associated disability.
P.07.15
INFLIXIMAB TROUGH LEVELS AND ANTI-DRUG ANTIBODIES
AFTER INDUCTION AS PREDICTIVE FACTORS OF LONG TERM
CLINICAL REMISSION
Bodini G.*
1
, Del Nero L.
1
, Giannini E.
1
, De Maria C.
1
, Baldissarro I.
1
,
Savarino V.
1
, Savarino E.
2
1
IRCCS San Martino, Genoa, Italy,
2
Gastroenterology Unit, Department
of Surgery, Oncology and Gastroenterology, Padua, Italy
Background and aim:
The treatment paradigm of Inflammatory
Bowel Disease is dramatically changed in the past decades, thanks to
the development of biological drugs. However, approximately 40%
of primary responder patients to anti-TNF therapy experience a loss
of response (LOR) during the first year of treatment. Recently, drugs
trough levels (TL) and anti-drug antibodies (ADA) presence were
proposed as useful tools in the management of patients who have
a LOR. Currently, one of the most important issue in IBD patients
on biological therapy is to timely identify patients at risk of anti-
TNF therapy failure. The aim of our prospective study is to evaluate
TL and ADA presence after Infliximab (IFX) induction and their
correlation whit a long term follow up in a series of patients with
Inflammatory Bowel Disease.
Material and methods:
In this prospective study we included 32
consecutive Inflammatory Bowel Disease patients [20 Crohn’s
Disease (CD) and 12 Ulcerative Colitis (UC); 17 males, median age
42 years, range 18-69] who underwent IFX therapy and achieved
clinical remission after induction (schedule: 5 mg/kg at week 0,
week 2, and week 6). Blood samples were drawn at standardized
time points (i.e., 0, 2, 6, and 14 week) before IFX infusion. TL and
IFX ADA were measured using an homogenous mobility shift assay
(HMSA; Prometheus Lab, San Diego, United States). Disease activity
was assessed both at week 14 and week 48 by the Harvey-Bradshaw
Index (HBI, remission defined by HBI<5) in CD patients and by the
Mayo score for UC patients (remission defined by Mayo score <2).
Results:
After 48 weeks follow-up, 14 patients (43.8%) experienced
LOR. We found significantly lower IFX TL after induction in patients
who experienced LOR as compared to patients who maintained
remission during the follow up (0.78 mcg/ml, range 0-14.97 mcg/
ml versus 10.01 mcg/ml, range 0.00-42.83 mcg/ml; P=0.0018).
Moreover, IFX TL were significantly lower in ADA positive patients
as compared to ADA negative ones (0 mcg/ml, range 0-9.66 mcg/
ml versus 11.91 mcg/ml, range 2.00-42.83 mcg/ml; P<0.0001).
Lastly, ADA concentration after induction was significantly higher
in relapsers as compared to patients in remission (3.13 U/ml, range
0-30.52 U/ml versus 0 U/ml, range 0-16.83 U/ml; P=0.02).
Conclusions:
Patients who experience LOR to IFX during long-term
follow-up (48 weeks) have significantly lower IFX TL and higher ADA
serum concentrations after IFX induction (i.e., 14 weeks). Therefore,
assessment of IFX TL and of ADA serum concentrations after IFX
induction can be used as a predictive tool for the long-term clinical
response to biological therapy.
P.07.16
PREDICTORS OF BOWEL DAMAGE AND DAMAGE PROGRESSION
AS ASSESSED BY THE LÉMANN INDEX IN EVERY-DAY CLINICAL
PRACTICE
Pedaci M.*
1
, Tontini G.E.
1
, Pescatori L.
2
, Spina L.
1
, Pastorelli L.
1
,
Annunziata M.L.
1
, Filippi E.
1
, Ambrogi F.
3
, Sconfienza L.
2
, Vecchi M.
1
1
Gastroenterology & Digestive Endoscopy Unit, IRCCS Policlinico
San Donato, San Donato Milanese, Milano, Italy,
2
Radiology Unit,
IRCCS Policlinico San Donato, San Donato Milanese, Milano, Italy,
3
Department of Clinical Sciences and Community Health, Medical
Statistics, Biometry and Bioinformatics, University of Milan, Milano,
Italy
Background and aim:
Crohn’s Disease (CD) shows a gradually and
destructive progression, leading to accumulation of structural bowel
damage (BD), loss of function and disability. The Lémann Index
(LI) is a new instrument to assess the cumulative BD according
to stricturing or penetrating lesions as well as surgical resections
detected at endoscopic and radiological evaluation [1]. Aim of this
study was to evaluate BD progression by LI scoring in patients with
CD, in the attempt to identify factors likely to predict its changes.
Material andmethods:
We retrospectively evaluated all consecutive
patients with a diagnosis of CD who received 2 or more serial CT or
MR enterographies at at least a 6 months time-distance from 2010 to
2015 at our Hospital. Two radiologists and two gastroenterologists
reviewed patients’ history, endoscopic examinations and cross-
sectional images. Two serial LI evaluations were calculated for each
patient and matched with CRP levels, Clinical Disease Activity Index
(CDAI), disease location, disease behavior, medical treatments,
CD-related hospitalizations and surgeries using the Spearman
correlation, theWilcoxon or the Mann-Whitney tests, as appropriate.
Results:
Twenty-eight patients were enrolled (15 men, median age
40.3 years). Most of them had a small-bowel (39%) or ileo-colonic
(46%) involvement and a luminal (36%) or a stricturing behavior
(43%) at baseline. The median LI was 7.7 (interquartile range [IQR]