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French cohort of early inflammatory back pain.  Study design  Data collection  Data analysis.

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Presentation on theme: "French cohort of early inflammatory back pain.  Study design  Data collection  Data analysis."— Presentation transcript:

1 French cohort of early inflammatory back pain

2  Study design  Data collection  Data analysis

3 French cohort of early inflammatory back pain  Study design  Data collection  Data analysis

4 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

5 French cohort of early inflammatory back pain Variables Time of collection (month) Patient’s assessmentXXXXXXXX Physical examinationXXXXXXXX Treatments / Co-morbiditiesXXXXXXXX Physician global assessment (dg of SpA)XXXXXXXX Laboratory assessmentXXXXXXXX ImagingXXXX Ultrasionography (enthesis)XXXX Bone densitometryXXXX Calendar Study design: Data collected

6 French cohort of early inflammatory back pain Variables Time of collection (month) Patient’s assessmentXXXXXXXX Medico-économics XXXXXXXX BASG XXXXXXXX BASDAI XXXXXXXX BASFI XXXXXXXX HAQ-AS XXXXXXXX SF36 XXXXXXXX Euro-Qol XXXXXXXX Physical examinationXXXXXXXX Treatments / Co-morbiditiesXXXXXXXX Physician global (dg of SpA)XXXXXXXX Laboratory assessmentXXXXXXXX ImagingXXXX Ultrasonography (enthesis)XXXX Bone densitometryXXXX Outcome measures Study design: Data collected

7 French cohort of early inflammatory back pain Variables Time of collection (month) Patient’s assessmentXXXXXXXX Physical examinationXXXXXXXX Weight XXXXXXXX Height XXXXXXXX Blood pressure XXXXXXXX Schober XXXXXXXX Chest expansion XXXXXXXX Occiput to wall XXXXXXXX Tragus to wall XXXXXXXX Finger to floor XXXXXXXX Spine lateral flexion XXXXXXXX Cervical spine rotation XXXXXXXX Inter-maleolar distance XXXXXXXX Treatments / Co-morbiditiesXXXXXXXX Physician global (dg of SpA)XXXXXXXX Laboratory assessmentXXXXXXXX ImagingXXXX Ultrasonography (enthesis)XXXX Bone densitometryXXXX Study design: Data collected

8 French cohort of early inflammatory back pain Variables Time of collection (month) Patient’s assessmentXXXXXXXX Physical examinationXXXXXXXX Treatments / Co-morbiditiesXXXXXXXX Physician global (dg of SpA)XXXXXXXX Laboratory assessmentXXXXXXXX CRP, ESRXXXXXXXX Cholestérol, triglycerides, glycemiaXXX B27 HLA antigenX DNAX RNAX*X*X*X* SerumXXXXX UrinesXXXXX ImagingXXXX Ultrasonography (enthesis)X ** Bone densitometryX*X* X ** Study design: Data collected *only centers from Paris area **only centers with DEXA and/or ultrasonographs

9 French cohort of early inflammatory back pain Variables Time of collection (month) Patient’s assessmentXXXXXXXX Physical examinationXXXXXXXX Treatments / Co-morbiditiesXXXXXXXX Physician global (dg of SpA)XXXXXXXX Laboratory assessmentXXXXXXXX ImagingXXXX Plain X-rays(cervical, thoracis, lumbar, pelvis) XXXX MRIXX*X* X*X* X*X* Ultrasonography (enthesis)X*X* X ** Bone densitometryX ** *only centers from Paris area **only centers with DEXA and/or ultrasonographs Study design: Data collected

10 French cohort of early inflammatory back pain  Study design  Data collection  Data analysis

11 French cohort of early inflammatory back pain Data collection  Who?  How?

12 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?

13 French cohort of early inflammatory back pain Data collection: How?  Clinical database  Radiological database  Biological database

14 French cohort of early inflammatory back pain Data collection: How?  Clinical database  Radiological database  Biological database

15 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)

16 French cohort of early inflammatory back pain Data collection: How?  Clinical database  Radiological database  Biological database

17 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)

18 French cohort of early inflammatory back pain Data collection: How?  Clinical database  Radiological database  Biological database

19 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)

20 French cohort of early inflammatory back pain  Study design  Data collection  Data analysis

21 French cohort of early inflammatory back pain Data analysis  Organization  Preliminary results

22 French cohort of early inflammatory back pain Data analysis  Organization  Preliminary results

23 French cohort of early inflammatory back pain Data analysis: organization  When?  How?  Who?

24 French cohort of early inflammatory back pain Data analysis: organization  When?  How?  Who?

25 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

26 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

27 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

28 French cohort of early inflammatory back pain Data analysis: organization  When?  How?  Who?

29 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

30 French cohort of early inflammatory back pain Data analysis: organization  When?  How?  Who?

31 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

32 French cohort of early inflammatory back pain Data analysis  Organization  Preliminary results

33 French cohort of early inflammatory back pain Data analysis  Description of the database  Presentation / publication

34 French cohort of early inflammatory back pain Data analysis  Description of the database  Presentation / publication

35 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

36 French cohort of early inflammatory back pain Description of the database Percentage of patients with recent inflammatory rachialgia and past history of….

37 French cohort of early inflammatory back pain Baseline characteristics ASAS criteria, Yes N = 479ASAS criteria, No N = 211 X-Rays+ MRI+ X-Rays+ MRI - X-Rays- MRI + X-Rays- MRI - B27+B27- Number133 (28%)49 (10%)98 (20%)185 (39%)8 (4%)203 (96%) Age30.2 ± ± ± ± ± ± 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] BASDAI38 [24 – 57]48 [19 – 62]44 [30 – 58]48 [29 – 61]43 [30 – 49]49 [36 – 63] BASDAI ≥40/10063 (47.7%)31 (64.6%)57 (58.2%)112 (60.9%)4 (50%)138 (68%) BASFI20 [9 – 47]31 [13 – 50]25 [12 – 44]28 [11 – 49]18 [11 – 27]25 [14 – 51] BASMI2.4 [1.8 – 3]3 [2 – 3.5]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%)

38 French cohort of early inflammatory back pain Data analysis  Description of the database  Presentation / publication

39 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

40 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

41 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

42 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!!!


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