Elsevier

Joint Bone Spine

Volume 78, Issue 6, December 2011, Pages 598-603
Joint Bone Spine

Original article
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

https://doi.org/10.1016/j.jbspin.2011.01.013Get rights and content

Abstract

Objectives

The French Society of Rheumatology has initiated a large national multicenter, longitudinal, prospective follow-up of patients presenting with early inflammatory back pain in order to set up a database to facilitate several investigations on diagnosis, prognosis, epidemiology, pathogenesis and medico-economics in the field of early inflammatory back pain and spondyloarthritis.

Methods

Patients were recruited if they had inflammatory back pain of more than 3 months and less than 3 years. Patients will be followed every 6 months during the first 2 years then every year during at least 5 years. Apart from information collected on a Case Report Form (demographics, disease activity, severity, co-morbidities, socio-economics, treatments, radiological and MRI evaluation of the spine and the pelvis according to the local investigators, and for some centers bone densitometry and ultrasonography of entheses), the digital X-rays and MRI of the spine and pelvis are stored using a specific software (Carestream) and the biological samples (DNA, RNA, sera, urines) are centralized at the Biological Resources Center (Bichat Hospital).

Results

The recruitment period of the 708 patients (mean age: 34 ± 9 years, female 54%, HLA-B27 positive: 57%) in the 25 centers was 26 months (from December 2007 to April 2010). The modified New York criteria, Amor criteria, ESSG criteria and axial ASAS criteria were fulfilled by 26%, 77%, 76% and 67% of the patients at entry, respectively. A history or current symptoms suggestive of peripheral arthritis, acute anterior uveitis and inflammatory bowel disease were observed in 21%, 9% and 4% of the patients, respectively. The disease was active (BASDAI: 45 ± 20) despite an NSAID intake in 66% of the patients.

Conclusion

This large cohort should facilitate the conduct of researches in different areas (clinical, medico-economics, translational) in order to improve our knowledge on the pathogenesis and natural history of axial spondyloarthritis.

Introduction

The group of diseases collectively now labeled spondyloarthritis consists of several disorders: psoriatic arthritis, reactive arthritis, arthritis related to inflammatory bowel disease, a subgroup of juvenile chronic arthritis and ankylosing spondylitis, with the last-mentioned being the prototype of spondyloarthritis [1], [2], [3]. The different clinical manifestations observed in these disorders include spinal (axial) manifestations, peripheral arthritis, enthesitis and extra-articular features such as uveitis, psoriasis and inflammatory bowel disease. The clinical argument in favor of this concept is the fact that such disorders may occur simultaneously or sequentially in a same patient or in a member of his/her family. In addition, some of the clinical characteristics of these diseases such as eye involvement and enthesitis are similar whatever the diagnosis [1], [2]. An experimental argument in favor of this concept is the fact that HLA-B27 transgenic rats develop the different clinical manifestations observed in humans with spondyloarthritis [4].

The axial symptoms are the most frequent and predominant at an early stage of the disease. Spondyloarthritis is usually occurring in young adults and might have a dramatic impact on the quality of life of patients. However, the natural history of spondyloarthritis seems to be heterogeneous with several forms from mild to severe disease. The current unresolved questions in the field of spondyloarthritis can be summarized in the following sub-categories:

  • diagnosis: sets of criteria [5], [6], [7] enabling the recognition of the disease at an early stage have been recently proposed [8] but require additional validation in a different setting;

  • prognosis: the natural history of axial spondyloarthritis is not well known [9], [10], [11]. The recognition of prognostic markers will facilitate the therapeutical decision at an early stage of the disease in particular the indication of drugs such as the TNF blockers which are costly but dramatically efficient [12], [13]. Such markers could be either a specific phenotype observed at an early stage of the disease or a biological marker such as acute phase reactants, cytokines, DNA or RNA specific expressions;

  • public health services: few data are available in France about quality of life and socio-economic consequences of spondyloarthritis [14], [15], [16].

These questions would be better addressed by obtaining periodic and prolonged follow-up over several years of patients presenting with early inflammatory back pain. To our knowledge, the first systematic prospective follow-up of patients with axial spondyloarthritis is the Outcome in Ankylosing Spondylitis International Study (OASIS) which included consecutive patients seen in three European departments of rheumatology with a mean disease duration of 12 years [16]. Another similar cohort (e.g. including patients at various duration stage of their disease) is also ongoing in Spain under the acronym of Regisponder [17]. In fact, only two recent cohorts are focused on patients seen at an early stage of the disease e.g. in Germany, the German Spondyloarthritis Inception Cohort (GESPIC) cohort [18] and in the Netherlands the Early Spondyloarthropathy Clinic (EsPac) [19]. More recently, the French Society of Rheumatology initiated a large national multicenter cohort, the so-called “DESIR cohort study” to facilitate investigations on diagnostic and prognostic markers but also aetiologic, pathogenic and socio-economic factors among patients with early inflammatory back pain suggestive of axial spondyloarthritis. DESIR is a French acronym for “devenir des spondyloarthropathies indifférenciées récentes”, “Outcome of recent undifferentiated spondyloarthritis”.

Section snippets

Study design

This is a longitudinal prospective cohort study in adults aged over 18 and less than 50 years from 25 regional centers in France. This study is fulfilling the current Good Clinical Practice Guidelines and has obtained the approval of the appropriate ethical committee. Participants at the study gave their written informed consent. A website containing the detailed description of the centers, the organization of the cohort but also the full detailed protocol and CRF is accessible at the following

Patients inclusion

A total of 708 patients with early inflammatory back pain were included between October 2007 and April 2010. All the centers were active and each regional center recruited between three and 73 patients (median 28).

Patients characteristics

The main characteristics of the patients are summarized in Table 1 and the activity and severity parameters of the disease are summarized in Table 2 with regard to the different available sets of criteria. It has to be noticed that among the 181 patients fulfilling the modified New

Discussion

This manuscript is summarizing the methodology and the baseline characteristics of the 708 patients with early inflammatory back pain.

The baseline characteristics of the patients and in particular the percentage of patients with MRI findings suggestive of inflammatory lesion of the sacroiliac joints (e.g. 33%) is very close to the anticipated one (between 30 to 50%).

Moreover, the relatively high percentage of patients fulfilling at entry the sets of criteria for spondyloarthritis confirms the

Disclosure of interest

The authors declare that they have no conflicts of interest concerning this article.

Acknowledgments

The DESIR cohort is conducted under the control of Assistance publique–Hôpitaux de Paris via the Clinical Research Unit Paris Centre and under the umbrella of the French Society of Rheumatology and Institut national de la santé et de la recherche médicale (Inserm). The database management is performed within the department of epidemiology and biostatistics (Professeur Jean-Pierre Daurès, D.I.M., Nîmes, France). An unrestricted grant from Pfizer Pharmaceuticals was allocated for the first 5 years

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