june 28, 2010 hankje escher - european medicines agency · eurokids (escher) web-based registry of...
TRANSCRIPT
June 28, 2010
Hankje
Escher
USA registries
European
registries
Longterm registry
(Centocor)
Pediatric IBD consortium (Heyman)
Start 2000: prevalent and incident cases, ±
1600
patients
6 sites: San Francisco, Chicago, Atlanta, Houston, Philadelphia, Boston
Publications
on:▪
Phenotype
▪
IFX premedication and infusion reactions ▪
Initial surgery risk in CD
▪
Gender related phenotype and disease course ▪
Age at onset-related phenotype and disease course
▪
Racial/ethnic differences ▪
Extraintestinal
manifestations
▪
Complications of CD
Pediatric IBD Collaborative Research Group (Hyams)
Start 2002, consecutive incident cases < 16 years, ±
250
cases
in 18 Eastern US and Canadian centers
prospective registration by research nurses
Publications on:▪
Response to CS in UC
▪
Response to CS and influence of IFX in CD▪
QoL
(IMPACT) at diagnosis and 1 year follow-up
▪
Lab tests at diagnosis▪
Perianal
disease in CD
▪
IFX maintenance in CD▪
Appraisal of PUCAI
▪
IFX maintenance in UC
EPIMAD (Colombel)
Start 1988, pediatric
and adult IBD, ±
500 pediatric
patients
Population based inception cohort
in Northern France
Interviewer practitioners collect data from pediatric gastroenterologists
Publications on:▪
Environmental risk factors in pediatric
IBD
▪
Incidence and disease location▪
Natural history of CD
▪
Malnutrition and Growth in CD
CEDATA (Buderus)
Germany and Austria, start 2004, ±
600
patients
Prevalent and incident cases, reported by pediatric
gastroenterologists
Data on: ▪
disease phenotype at presentation
▪
first
treatment
SIGENP IBD Study Group
Italian Pediatric
National pediatric
IBD register
start 1996, patients at diagnosis, ±
1500 patients
all 40 ped
gastroenterology centers
in Italy
retrospective and prospective
Publication on:▪
Incidence and phenotype
EUROKIDS (Escher)
Web-based registry of ESPGHAN IBD working group
in 18 European countries and Israel
incident cases < 18 years, registration at diagnosis
Start 2004, ongoing, now ±
3000 patients
Continued
registration
of new
patients
Open for
new
participants, new
countries
Data on:▪
Diagnostic
work-up
▪
Disease
location
in CD▪
Disease
location
in UC and IBD-U
▪
Height
and weight
at diagnosis▪
Colitis
in the very
young
Initiative of IBD working group of ESPGHAN
Start May 2004 with 21 centres
in 12 countries
now 18 countries
Prospective registration of newly diagnosed IBD patients
Data entry:•
2004 –
2006: electronic forms sent by email
•
2006 –
now: web-based registry
Coordination in Rotterdam, The Netherlands
United KingdomUnited Kingdom
DenmarkDenmark
SwedenSweden
PortugalPortugal
FranceFrance
GermanyGermanyPolandPoland
Czech RepublicCzech Republic
CroatiaCroatia
ItalyItaly
NetherlandsNetherlands
IsraelIsrael
NorwayNorway
BelgiumBelgium
GreeceGreece
LatviaLatvia
HungaryHungarySloveniaSlovenia
Cohort May 2004 – May 2009n=2280
Study cohortn=2087
Exclusion:4 patients > 18 years at diagnosis
Exclusion:143 patients retrospectively
included
Exclusion:12 patients without diagnosis
Exclusion: 34 patients with incorrect date of
diagnosis*
CD (n=1227) IC (n=195) UC (n=665)
* Date of diagnosis > 1 month after date of registration
0 50 100 150 200 250
Royal Hospital for Children Bristol
Birmingham Children's Hospital
Polish-American Children's Hospital, Jagiellonian University Cracow
Karolinska Inst itute Stockholm
Hvidovre Hospital Copenhagen
Dr. v. Haunersches Kinderspital, Ludwig-M aximillians-University M unich
Erasmus M C-Sophia Children's Hospital Rotterdam
M edical University of Warsaw
The Children's M emorial Health Inst itute Warsaw
Chelsea and Westminster Hospital London
University of Rome La Sapienza
Children's Hospital Zagreb
Charles University Teaching Hospital Hradec Kralove
University of Athens
University Children's M edical Centre Bonn
Queen M ary's Hospital for Children Surrey
M eyer Hospital Florence
E. Wolfson M edical Centre Tel Aviv
Hopital Necker-Enfants M alades Paris
Ostfold Central Hospital
University Hospital Prague-M otol
Edmond & Lili Safra Children's Hospital, Sheba M edical Centre Tel Hashomer
Semmelweis Egyetem I. sz. Gyermekklinika Budapest
Hospital S. Joao Porto
Universita degli Studi di Napoli Federico II Napoli
Childrens hospital Ljublana
UZ Gent
Hospital Robert Debre, AP-HP Paris
Akademiska Barnsjukhuset Uppsala
St if tung Deutsche Klinik fur Diagnost ik GM BH Wiesbaden
Children's Hospital, Technical University Dresden
Koningin Paola Kinderziekenhuis Antwerpen ZNA
Childrens Hospital Brescia
Childrens University Hospital Riga
Total patients patients with missing/wrong data
Mean
age
at diagnosis 12.5 years
Mean
diagnostic
delay
5 months
Ethnicity
86% Caucasian
1st
degree
family
history
in 10.6%
Extraintestinal
symptoms
in 18.3%
Perianal
disease
in 9.1%
Stenosis
in 13.6%
57% had complete Porto work-up
= upper GI + ileocolonoscopy
+ small
bowel
imaging
88% upper GI endoscopy
88% colonoscopy
70% terminal ileum
70% imaging
of small
bowel
(SBFT, MRI)
95% terminal ileum
visualised
by
endoscopy
or
radiology
1%
29%
29%
12%
18%
4%
6%
0% 5% 10% 15% 20% 25% 30% 35%
only upper GI
ileocolon + upper GI
ileocolon
colon + upper GI
colon
ileum + upper GI
ileum
N=990
Centocor; FDA and EMEA mandate
USA (start 2007?)
6 European
(start 2009) countries
Europe
10-15 sites
France, Italy, Germany, UK, Belgium, Netherlands
5000 patients, 20 year
follow-up
2000 Crohn’s
disease, IFX treated
2000 Crohn’s
disease, not
IFX treated
1000 ulcerative
colitis/unclassified