Download P380. Comparative study of infliximab and adalimumab induction

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throughout the experiment in both groups. Besides mild adverse
effects such as tingling, itching and skin redness, no severe side
effect was observed.
Conclusions: For chronic abdominal pain in IBD tDCS seems to
be an effective and clinical relevant adjunct therapy. The analgesic effects seen were independent from inflammation and disease
activity. This emphasises that central pain mechanisms are involved
in chronic abdominal pain. This is in line with clinical observations that pain can persist even if mucosal inflammation is healed.
Therefore our next study aims to investigate structural and functional changes in the brain due to chronic abdominal pain in IBD
by MRI.
P380
Comparative study of infliximab and
adalimumab induction therapy for clinical
remission and mucosal healing in paediatric
patients with active Crohn’s disease
E. Szymanska*1, M. Dadalski2, S. Szymanska3, W. Grajkowska3,
M. Pronicki3, K. Jaroslaw2
1
Children’s Memorial Health Institute, Department of Paediatrics,
Nutrition and Metabolic Disorders, Warsaw, Poland, 2Children’s
Memorial Health Institute, Department of Gastroenterology,
Hepatology and Feeding Disorders, Warsaw, Poland, 3Children’s
Memorial Heath Institute, Department of Pathology, Warsaw, Poland
Background: Infliximab (IFX) and adalimumab (ADA) are considered to be equally effective in induction and maintenance of clinical
remission and mucosal healing. Some data have shown positive outcomes with ADA as a second-line therapy in patients not responding
or loosing response to IFX. The aim of this study was to compare
clinical efficacy of both anti-TNF agents.
Methods: In total, 56 CD patients treated with IFX, and 23 children
receiving ADA were included into the study. Endoscopy with sample
collection was performed in all patients before and after 3 injections of anti-TNF agents. Clinical activity of the disease was assessed
using the Paediatric Crohn’s Disease Activity Index (PCDAI), and the
endoscopic activity was scored using the Simple Endoscopic Score
(SES-CD). Histological changes were evaluated by a previously
described numerical scoring system.
Results: Median baseline PCDAI scores and outcomes following induction therapy with IFX and ADA were as following;
IFX = 55.0 (40.0–85.0) vs 7.5 (2.5–40.0)], ADA = 45.0 (30.0–
65.0) vs 10.0 (0.0–15.0). Median baseline SES-CD scores and
outcomes following induction therapy with INF and ADA were
as following; IFX = 10.0 (0.0–32.0) vs 5.0 (0.0–23.0), ADA,
14.0 (6.0–27.0) vs 9.0 (0.0–27.0). Median baseline histological
scores and outcomes following induction therapy with INF and
ADA were as following; IFX = 5.5 (0.0–10.0) vs 4.0 (0.0–12.0),
ADA = 5.7 (0.0–15.0) vs 4.0 (0.0–12.0). In 7/23 patients ADA
was used as a second-line biologic agent. In this patients worse
clinical response was observed. Median PCDAI scores following
induction therapy with ADA in patients previously treated with
IFX vs anti-TNF-naïve ones were as following: 17.5 (0.0–32.0) vs
15.0 (0.0–15.0).
Conclusions: Efficacy of IFX and ADA in induction of clinical
remission and mucosal healing in Polish paediatric patients is comparative. Biologic agents are more effective in anti-TNF-alfa naïve
patients.
P381
An observational study of adverse events of
patients with inflammatory bowel disease
receiving parenteral iron
A. Wilson*, E. Murray, G. B. Turner
Belfast Trust, Belfast, United Kingdom
Background: Intravenous iron is often indicated in inflammatory
bowel disease (IBD) because of intolerance or inefficacy of oral therapy. Although safe, IV iron is associated with adverse reactions and
hypersensitivity. We observed a higher rate of adverse reactions in
IBD patients than in a non-IBD population and set out to formally
study this and to report a strategy for delivering IV iron to patients
with IBD who have had a hypersensitivity reaction.
Methods: An ambulatory IV iron clinic was set up in the Belfast
in 2011, taking referrals from gastroenterology, GI surgery and an
intestinal failure clinic from 3 acute hospitals. We collated clinical
data from all patients attending our service from 2011 to 2015.
We recorded all adverse events in patients that received IV iron
and established whether each patient had IBD. Hypersensitivity
with IV iron is generally associated with fast infusion rates and
higher concentrations of iron. Pre-treating individuals with sensitivity has been used successfully with contrast media and biological agents.
The lack of treatment options for IBD patients with hypersensitivity
to IV iron prompted an attempt to re-challenge carefully selected
patients with prior moderate-to-severe hypersensitivity reactions.
Where no other options were identified for such patients, pre-treatment with 200 mg of IV hydrocortisone and 10mg IV chlorphenamine was administered 1 hour before a reduced 600 mg dose of ferric
carboxymaltose in 250 mls over 1 hour.
Results: In total, 455 patients were included, of which 171 had IBD.
Further, 22 patients had an adverse event with a statistically significant increase in all adverse events in IBD compared with non-IBD
patients: 8.2% v 2.8% (p = 0.0096). There was also a higher rate of
hypersensitivity in patients with IBD (5.3%) compared with those
without IBD (0%). (p = 0.0001).
In addition, 6 patients with prior hypersensitivity were re-challenged
using the above protocol. Next, 19 infusions were delivered to these
6 patients with only 1 moderate hypersensitivity reaction reported
(during second infusion developed transient dyspnoea, flushing, and
nausea).
Conclusions: We demonstrate that IBD is associated with a higher
rate of adverse events with IV iron, particularly hypersensitivity.
We report successful IV iron delivery to 5 of 6 patients with a history of previous reaction to IV iron. We utilised pre-treatment and
delivered a less concentrated solution at a slower rate.
Table 1. Adverse reaction data by type and with/without IBD
Type of reaction
All patients
(n = 455)
without IBD
(n = 284)
Hypersensitivity
Flu-like illness
Dermatological
Vomiting
Delayed nausea
Severe coughing
Total
9
4
4
1
3
1
22
1
2
1
3
1
8
with IBD
(n = 171)
9
3
2
14