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French cohort of early inflammatory back pain
French cohort of early inflammatory back pain
Study design
Data collection
Data analysis
French cohort of early inflammatory back pain
Study design
Data collection
Data analysis
French cohort of early inflammatory back pain
Inflammatory back pain (Berlin or Calin criteria)
Probability of spondylarthropathy >50% based on the physician’s assessment
Age >18, <50
Symptoms duration >3 months, <3years
Referral from rheumatologists, GP, … patients
Study design: Key inclusion criteria
French cohort of early inflammatory back pain
VariablesTime of collection (month)
0 6 12 18 24 36 48 60
Patient’s assessment X X X X X X X X
Physical examination X X X X X X X X
Treatments / Co-morbidities X X X X X X X X
Physician global assessment (dg of SpA) X X X X X X X X
Laboratory assessment X X X X X X X X
Imaging X X X X
Ultrasionography (enthesis) X X X X
Bone densitometry X X X X
Calendar
Study design: Data collected
French cohort of early inflammatory back pain
VariablesTime of collection (month)
0 6 12 18 24 36 48 60
Patient’s assessment X X X X X X X XMedico-économics X X X X X X X XBASG X X X X X X X XBASDAI X X X X X X X XBASFI X X X X X X X XHAQ-AS X X X X X X X XSF36 X X X X X X X XEuro-Qol X X X X X X X X
Physical examination X X X X X X X XTreatments / Co-morbidities X X X X X X X XPhysician global (dg of SpA) X X X X X X X XLaboratory assessment X X X X X X X X
Imaging X X X X
Ultrasonography (enthesis) X X X X
Bone densitometry X X X X
Outcome measures
Study design: Data collected
French cohort of early inflammatory back pain
VariablesTime of collection (month)
0 6 12 18 24 36 48 60
Patient’s assessment X X X X X X X X
Physical examination X X X X X X X XWeight X X X X X X X X
Height X X X X X X X X
Blood pressure X X X X X X X X
Schober X X X X X X X X
Chest expansion X X X X X X X X
Occiput to wall X X X X X X X X
Tragus to wall X X X X X X X X
Finger to floor X X X X X X X X
Spine lateral flexion X X X X X X X XCervical spine rotation X X X X X X X XInter-maleolar distance X X X X X X X X
Treatments / Co-morbidities X X X X X X X X
Physician global (dg of SpA) X X X X X X X X
Laboratory assessment X X X X X X X X
Imaging X X X X
Ultrasonography (enthesis) X X X X
Bone densitometry X X X X
Study design: Data collected
French cohort of early inflammatory back pain
VariablesTime of collection (month)
0 6 12 18 24 36 48 60
Patient’s assessment X X X X X X X X
Physical examination X X X X X X X X
Treatments / Co-morbidities X X X X X X X X
Physician global (dg of SpA) X X X X X X X X
Laboratory assessment X X X X X X X X
CRP, ESR X X X X X X X X
Cholestérol, triglycerides, glycemia X X X
B27 HLA antigen X
DNA X
RNA X* X*
Serum X X X X X
Urines X X X X X
Imaging X X X X
Ultrasonography (enthesis) X** X** X** X**
Bone densitometry X* X** X** X**
Study design: Data collected
*only centers from Paris area**only centers with DEXA and/or ultrasonographs
French cohort of early inflammatory back pain
VariablesTime of collection (month)
0 6 12 18 24 36 48 60
Patient’s assessment X X X X X X X X
Physical examination X X X X X X X X
Treatments / Co-morbidities X X X X X X X X
Physician global (dg of SpA) X X X X X X X X
Laboratory assessment X X X X X X X X
Imaging X X X X
Plain X-rays(cervical, thoracis, lumbar, pelvis) X X X X
MRI X X* X* X*
Ultrasonography (enthesis) X* X** X** X**
Bone densitometry X** X** X** X**
*only centers from Paris area**only centers with DEXA and/or ultrasonographs
Study design: Data collected
French cohort of early inflammatory back pain
Study design
Data collection
Data analysis
French cohort of early inflammatory back pain
Data collection
Who?
How?
French cohort of early inflammatory back pain
Brest
Le Mans
Tours
Clermont-Ferrand
Bordeaux
Toulouse
Montpellier
Lille
Amiens
Nancy
Besançon
Dijon
Nice
Marseille
Paris area: 11 centers
Data collection: Who?
French cohort of early inflammatory back pain
Data collection: How?
Clinical database
Radiological database
Biological database
French cohort of early inflammatory back pain
Data collection: How?
Clinical database
Radiological database
Biological database
French cohort of early inflammatory back pain
Clinical database
Data collection (investigators/paper CRF) Data entry (CRO: ClinInfo) Data quality control (Nîmes [Pr Daurès]) Data queries (Paris Clinical Research Unit) Database storage (Nîmes [Pr Daurès])
(questionnaires, physical examination, local imaging reading, BMD, US)
French cohort of early inflammatory back pain
Data collection: How?
Clinical database
Radiological database
Biological database
French cohort of early inflammatory back pain
Radiological database
Data collection (investigators / CD) Data entry (Paris Clinical Research Unit) Data storage (Paris, …)
(Pelvic X-rays, Spine X-rays, MRI)
French cohort of early inflammatory back pain
Data collection: How?
Clinical database
Radiological database
Biological database
French cohort of early inflammatory back pain
Biological database
Data collection (investigators / specific material) Data storage (Biologic Ressource Center / Bichat
Hospital [Paris])
(Serum, urines, DNA, RNA)
French cohort of early inflammatory back pain
Study design
Data collection
Data analysis
French cohort of early inflammatory back pain
Data analysis
Organization
Preliminary results
French cohort of early inflammatory back pain
Data analysis
Organization
Preliminary results
French cohort of early inflammatory back pain
Data analysis: organization
When?
How?
Who?
French cohort of early inflammatory back pain
Data analysis: organization
When?
How?
Who?
French cohort of early inflammatory back pain
Data analysis: When?
after the last patient has completed the last visit (clinical trial)
every year for all patients (cohorts) every year for the visits for which data
are available for all patients
after the database has been locked
French cohort of early inflammatory back pain
Data analysis: When?
after the last patient has completed the last visit (clinical trial)
every year for all patients (cohorts) every year for the visits for which data
are available for all patients
after the database has been locked
French cohort of early inflammatory back pain
Data analysis: When?
M0: June 2010 M0 + M12: June 2011 M0 M24: June 2012 M0 M36: June 2013 M0 M48: June 2014 M0 M60: June 2015
French cohort of early inflammatory back pain
Data analysis: organization
When?
How?
Who?
French cohort of early inflammatory back pain
Data analysis: How?
RFP: Request For Proposal of a research question (twice a year) Specifif format for application Scientific committee: Fautrel Bruno, Richette Pascal, Miceli-Richard Corinne,
Benessiano Joëlle, Berenbaum Francis, Breban Maxime, Claudepierre Pascal, Combe Bernard, Cotten Anne, d’Agostino Maria-Antonietta, Dargent Patricia, Daurès Jean-Pierre, Dougados Maxime, Goupille Philippe, Logeart Isabelle, Pham Thao, Roux Christian, Rudwaleit Martin, Saraux Alain, van der Heijde Désirée, Wendling Daniel
Review of the applications by the reviewers (within and outside the scientific committee)
Decision by the scientific committee If OK, the database is provided to the applicant
French cohort of early inflammatory back pain
Data analysis: organization
When?
How?
Who?
French cohort of early inflammatory back pain
Data analysis: Who?
Embargo period: 2 years after the date a specific database has been locked
During the embargo period: Investigators Scientific committee members
After the embargo period: Any researcher
French cohort of early inflammatory back pain
Data analysis
Organization
Preliminary results
French cohort of early inflammatory back pain
Data analysis
Description of the database
Presentation / publication
French cohort of early inflammatory back pain
Data analysis
Description of the database
Presentation / publication
French cohort of early inflammatory back pain
- Age: n = 708 m = 33.7 SD = 8.6 Range = [18 – 60.6]
- Sex: Male n = 327 (46 %)
- B27 positive: n = 410 (57.9 %)
- Radiologic sacroiliitis: n = 182 (25.7 %)
Description of the database
French cohort of early inflammatory back pain
Description of the database
3%
16%
9%
45%
13%
49%
21%
0%
50%
100%
periphericalarthritis
Enthesitis Dactylitis(n=92)
Chest pain Uveitis (n=60) Psoriasis(n=112)
IBD (n=21)
Percentage of patients with recent inflammatory rachialgia and past history of….
French cohort of early inflammatory back pain Baseline characteristics
ASAS criteria, Yes N = 479 ASAS criteria, No N = 211
X-Rays+MRI+
X-Rays+MRI -
X-Rays-MRI +
X-Rays-MRI -
B27+ B27-
Number 133 (28%) 49 (10%) 98 (20%) 185 (39%) 8 (4%) 203 (96%)
Age 30.2 ± 8 34.2 ± 10.8 34 ± 8.2 34 ± 8.3 29.5 ± 7.1 35.6 ± 8.4
Sex (% women) 50 (38%) 23 (47%) 41 (42%) 110 (60%) 5 (63%) 129 (64%)
Symptoms duration (months) 19 [11 – 26] 18 [9 – 29] 15 [7 – 28] 17 [10 – 27] 13 [6 – 26] 16 [9 – 24]
BASDAI 38 [24 – 57] 48 [19 – 62] 44 [30 – 58] 48 [29 – 61] 43 [30 – 49] 49 [36 – 63]
BASDAI ≥40/100 63 (47.7%) 31 (64.6%) 57 (58.2%) 112 (60.9%) 4 (50%) 138 (68%)
BASFI 20 [9 – 47] 31 [13 – 50] 25 [12 – 44] 28 [11 – 49] 18 [11 – 27] 25 [14 – 51]
BASMI 2.4 [1.8 – 3] 3 [2 – 3.5] 2 [1.6 – 3] 2 [1.6 – 3] 1.9 [1 – 2.3] 2.3 [1.8 – 3]
NSAID score (3 last months) 50 [17 – 93] 57 [36 – 112] 50 [21 – 89] 56 [30 – 100] 8,2 [0 – 30] 34 [7 – 74]
NSAIDscore (6 last months) 43 [15 – 82] 47 [20 – 95] 36 [12 – 67] 44 [20 – 79] 14 [2 – 22] 25 [5 – 55]
Uveitis+ 16 (12%) 4 (8%) 9 (9%) 15 (8%) 0 (0%) 13 (6%)
Arthritis+ 25 (19%) 15 (31%) 20 (20%) 38 (21%) 0 (0%) 43 (21%)
Enthesitis+ 47 (35%) 29 (59%) 48 (49%) 98 (53%) 0 (0%) 114 (56%)
French cohort of early inflammatory back pain
Data analysis
Description of the database
Presentation / publication
Presentations during congress (1/2)
Smokers in early axial spondyloarthritis have an earlier disease onset, more inflammation and damage: results from the DESIR cohort. Oral presentation
Do HLA-B27 positive patients differ from HLA-B27 negtive patients in clinical presentation and imaging? Results from the DESIR cohort on patients with recent onset in ……… arthritis.
Poster
Psoriasis influences the phenotype of patients with early inflammatory back pain: data from the DESIR cohort. Oral presentation
Past history or present symptoms of extra-spinal manifestations are frequent in patients presenting with recent inflammatory back pain: data from the DESIR cohort.Poster
Comparison of axial spondyloarthropathy (ASPA) and non ASPA patients rheumatologist diagnosis among a recent inflammatory back pain patients cohorts – the DESIR cohort.
Oral presentation
Presentations during congress (2/2)
Impact of uveitis on the phenotype of patients with recent inflammatory back pain. Poster
Smokers in early axial spondyloarthritis have an earlier disease onset, more inflammation and damage: results from the DEvenir des Spondyloarthropathies Indifférenciées Récentes cohort. Oral presentation
Association between axial pain site and site of MRI inflammatory lesions or structural change in patietns with early inflammatory back pain. The DESIR cohort study. Oral presentation
Differences between women and men with recent onset axial spondyloarthritis: results from the DESIR cohort. Poster
Three phenotype profiles are revealed by cluster analysis in early inflammatory back pain suggestive of spondyloarthritis (SpA). Results from the Devenir des Spondyloarthropathies Indifférenciées Récentes (DESIR) cohort. Poster
Publications
1. The DESIR cohort: A 10-year follow-up of early inflammatory back pain in France: Study design and baseline characteristics of the 708 recruited patients.Dougados M, d’Agostino MA, Benessiano J, Berenbaum F, Breban M, Claudepierre P, Combe B, Dargent-Molina P, Daurès JP, Fautrel B, Feydy A, Goupille P, Leblanc V, Logeart I, Pham T, Richette P, Roux C, Rudwaleit M, Saraux A, Treluyer JM, van der Heijde D, Wendling M.Joint Bone Spine 2011 Mar 30 [Epub ahead of print]
2. HLA-B27 positive patients differ from HLA-B27 negative patietns in clinical presentation and imaging: Results from the DESIR cohort of patients with recent onsel axial spondyloarthritis.Chung HY, Machado P, vander Heijde D, Dougados M.Ann Rheum Dis 2011;in press
French cohort of early inflammatory back pain
Conclusions
1. Potential interest of the collected data Burden of the disease Treatment effect in daily practice Physiopathology
2. YOU ARE WELCOME TO SUBMIT A RESEARCH
PROJECT!!!
www.lacohortedesir.fr
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