Disease pattern of spondyloarthropathies in Spain: description of the first national registry (REGISPONSER) extended report.
ABSTRACT The national registry of spondyloarthropathies (REGISPONSER) is launched to classify patients with this group of diseases treated in Spanish rheumatology clinics. This manuscript describes the methodological and organizational background as well as characteristics of patients finally included, and provides a comparative analysis between characteristics of both ankylosing spondylitis and undifferentiated spondyloarthropathy groups of patients.
Twelve members of the GRESSER group have participated in the registry, for a one-year recruitment period. All consecutively registered adult patients treated in their clinics met the classification criteria of the European Spondyloarthropathies Study Group (ESSG). Data collected reflect the socio-demographic characteristics, as well as disease activity and functional status, clinical form at onset, treatment used and quality of life; all measured by standard instruments.
Throughout 1 yr, 1385 patients have been included in the registry: 939 males (68%) and 440 females (32%), with an average age of 47 +/- 13 years (mean +/- s.d.), and an average disease duration of 12 +/- 9 years. Diagnoses of the included patients were: AS (n = 842, 61%), PsA (n = 290, 21%), u-SpA (n = 205, 15%), reactive arthritis (n = 16, 1.2%), inflammatory bowel disease arthritis (n = 13, 0.9%) and JCA-spondyloathropathy (n = 13, 0.9%). Regarding clinical form, 54% had axial disease, 20% peripheral disease, 24% mixed disease and 0.6% isolated enthesitic form. Low-back pain was the first symptom reported in 53% of the patients, and most common extra-articular disease manifestations were psoriasis (25%), anterior uveitis (16%) and intestinal inflammatory disease (4%). Some kind of work disability was reported by 353 patients (25.5%).
Such databases are very useful to obtain information about characteristics of SpA patients treated in a certain location or following a specific treatment practice, and provide a tool for assessing the impact of the disease. Data collected in this registry provide an appropriate clinical and demographic profile of patients suffering from SpA in Spain.
Article: SpondyloarthropathiesCurrent Opinion in Rheumatology 06/1997; 9(4):281-283. · 5.19 Impact Factor
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ABSTRACT: The objective of the EPISER study was to estimate the prevalence of rheumatoid arthritis (RA), low back pain, hand and knee osteoarthritis (OA), and fibromyalgia in the adult Spanish population, and to assess the impact of these diseases on function and quality of life, and use of health and social resources. 2998 subjects aged 20 years or above were randomly selected by stratified multistage cluster sampling from the censuses of 20 municipalities. Trained rheumatologists carried out structured visits at which subjects were asked about rheumatic symptoms and sociodemographic characteristics, completed validated instruments for measuring function (HAQ) and quality of life (SF-12), and underwent a standardised physical examination. Cases were defined by previously validated criteria. The estimated prevalences with 95% confidence intervals were as follows: RA lifetime cumulative: 0.5% (0.3 to 0.9); low back pain: 14.8% (12.2 to 17.4); symptomatic knee OA: 10.2% (8.5 to 11.9); hand OA: 6.2% (5.9 to 6.5); fibromyalgia: 2.4% (1.5 to 3.2). Most conditions significantly impaired function and quality of life. The EPISER study has internal and external validity for application of the results to the adult Spanish population. The diseases studied affect a significant proportion of the population, with various degrees of impact on disability and quality of life resulting in a significant number of physician visits, work disability, and medication use.Annals of the Rheumatic Diseases 12/2001; 60(11):1040-5. · 9.11 Impact Factor
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ABSTRACT: The existence of population and disease registers is crucial for epidemiologic research. Continuous registration over many years provides a particular advantage. The example of asbestos and lung cancer is used to illustrate the importance of register-based studies for the assessment of an association between an exposure and a clinical disease. It is an important challenge for epidemiologists in the ongoing debate on data confidentiality constantly to convince the public about the benefits of our work.Public health reviews 01/1994; 21(3-4):263-70.
Disease pattern of spondyloarthropathies in Spain: description
of the first national registry (REGISPONSER)—extended report
E. Collantes, P. Zarco1, E. Mun ˜ oz, X. Juanola2, J. Mulero3, J. L. Ferna ´ ndez-Sueiro4,
J. C. Torre-Alonso5, J. Grataco ´ s6, C. Gonza ´ lez7, E. Batlle8, P. Ferna ´ ndez9, L. F. Linares10,
E. Brito11and L. Carmona12
Objective. The national registry of spondyloarthropathies (REGISPONSER) is launched to classify patients with this group of diseases
treated in Spanish rheumatology clinics. This manuscript describes the methodological and organizational background as well as
characteristics of patients finally included, and provides a comparative analysis between characteristics of both ankylosing spondylitis and
undifferentiated spondyloarthropathy groups of patients.
Patients and methods. Twelve members of the GRESSER group have participated in the registry, for a one-year recruitment period.
All consecutively registered adult patients treated in their clinics met the classification criteria of the European Spondyloarthropathies Study
Group (ESSG). Data collected reflect the socio-demographic characteristics, as well as disease activity and functional status, clinical form at
onset, treatment used and quality of life; all measured by standard instruments.
Results. Throughout 1yr, 1385 patients have been included in the registry: 939 males (68%) and 440 females (32%), with an average age of
47?13 years (mean? S.D.), and an average disease duration of 12?9 years. Diagnoses of the included patients were: AS (n¼842, 61%),
PsA (n¼290, 21%), u-SpA (n¼205, 15%), reactive arthritis (n¼16, 1.2%), inflammatory bowel disease arthritis (n¼13, 0.9%) and JCA-
spondyloathropathy (n¼13, 0.9%). Regarding clinical form, 54% had axial disease, 20% peripheral disease, 24% mixed disease and 0.6%
isolated enthesitic form. Low-back pain was the first symptom reported in 53% of the patients, and most common extra-articular disease
manifestations were psoriasis (25%), anterior uveitis (16%) and intestinal inflammatory disease (4%). Some kind of work disability was
reported by 353 patients (25.5%).
Conclusions. Such databases are very useful to obtain information about characteristics of SpA patients treated in a certain location or
following a specific treatment practice, and provide a tool for assessing the impact of the disease. Data collected in this registry provide an
appropriate clinical and demographic profile of patients suffering from SpA in Spain.
KEY WORDS: Spondyloarthropathies, Ankylosing spondylitis, Undifferentiated spondyloarthropathies, Epidemiology, Disease registry.
Spondyloarthropathies (SpA) are a heterogeneous group of
inflammatory interrelated diseases involving peripheral joints
and spine and sharing similar clinical, epidemiological, radiolo-
gical and immunogenetic features. Ankylosing spondylitis (AS) is
the prototype disease of this group; other clinical entities include
reactive arthritis (ReA), arthritis and spondylitis associated with
psoriasis (PsA) or inflammatory bowel disease (IBD) and
undifferentiated spondyloarthropathies (u-SpA) . SpA preva-
lence has not been definitely established, as epidemiologists
have started focusing on this disease recently. Prevalence might
be around 0.23–1.8% . In Spain, there are no occurrence
studies in the general population, but the National Study of
Validation of SpA Classification Criteria  estimated a
prevalence of 13% (range 8–16%) of patients with any SpA
treated at rheumatology clinics. The prevalence of inflammatory
low-back pain is 0.8% [95% confidence interval (CI): 0.6–1.0], as
found in the EPISER study . The clinical spectrum that defines
patients with these diseases is very broad and includes four
syndromes: (i) spinal, affecting sacroiliac joints and axial skeleton,
(ii) peripheral arthritis, (iii) enthesitis and (iv) extra-skeletal,
expressed with various degrees of intensity in different clinical
Health care managers need reliable data from instruments to
help them distribute and allocate health and social resources
objectively and fairly. These instruments should be flexible and
provide real-time data, and they should easily incorporate any
changes in practice and scientific knowledge. Disease registries are
more suitable for this task, as they provide real time data about
frequency, geographic and temporary distribution, as well as
disease pattern . They inform about the case mix in different
locations and provide an enlightening tool for assessing the impact
of the disease and clinical practice variability. Furthermore,
disease registries are an ideal source of random samples for cohort
studies or case-control studies, the correct setting to test medical
hypothesis . There are many examples of large clinical
databases in rheumatology , some of which also include genetic
banks . There are specific registries or databases such as those
of paediatric rheumatic diseases , scleroderma  or rheuma-
toid arthritis  and psoriatic arthritis in North America .
There are also less specific registries, such as the National
Databank of Rheumatic Diseases (NDBRD), developed in the
USA  more than two decades ago, in which clinical
information is compiled prospectively from many rheumatology
clinics , or the National Database of German Arthritis
Centres . Clinical databases have been applied to evaluate
surgical treatment outcomes  and monitor safety after the
introduction of new expensive drugs [16, 17].
Department of Rheumatology, Hospital ‘Reina Sofia’ and University of Co ´rdoba,
Co ´rdoba,1Department of Rheumatology, Foundation Hospital of Alcorco ´n, Madrid,
2Department of Rheumatology, Hospital of Bellvitge, Barcelona,3Department of
Rheumatology, Hospital Puerta de Hierro, Madrid,4Department of Rheumatology,
Hospital Juan Canalejo, A Corun ˜a,5Department of Rheumatology, Hospital Monte
Naranco, Oviedo,6Department of Rheumatology, Hospital Parc Taulı ´, Sabadell,
7Department of Rheumatology, Hospital Gregorio Maran ˜o ´n, Madrid,8Department
of Rheumatology, Hospital General, Alicante,
Hospital Doce de Octubre, Madrid,
Virgen Arrixaca, Murcia,11Department of Rheumatology, Hospital Ramo ´n y Cajal,
Madrid and12Department of Research Unit, Spanish Foundation of Rheumatology,
9Department of Rheumatology,
10Department of Rheumatology, Hospital
Submitted 18 November 2006; revised version accepted 14 March 2007.
Correspondence to: Prof E. Collantes-Este ´vez, MD, PhD, Department of
Rheumatology, Hospital Universitario Reina Sofı ´a, Menendez Pidal, s/n 14004
Co ´rdoba, Spain. E-mail: email@example.com
Advance Access publication 27 May 2007
? The Author 2007. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: firstname.lastname@example.org
by guest on May 30, 2013
The experience with registries or large clinical databases in SpA
is limited to a recently approved international registry of PsA 
and a Finnish registry of twins with AS . Our group aimed to
design and develop an online registry of patients with SpA in our
setting. The way to collect variables should be in agreement with
major international working groups in SpA, namely ASAS, and
simple enough so it can be feasible to adapt to clinical practice.
The information collected should allow us to evaluate the
SpA clinical pattern in our environment, and provide us with
a representative population with SpA so as to draw random
samples for future hypothesis-testing projects. The main aim of
this project is to classify patients with SpA treated in Spanish
rheumatology clinics. This manuscript describes a methodological
and provides a description of patients finally included and
a comparative analysis between characteristics of both AS and
u-SpA groups of patients.
Patients and methods
In April 2004, the Spanish Spondyloarthropathies Study Group
of the Spanish Society of Rheumatology (GRESSER) launched
the National Spondyloarthropathies Registry (REGISPONSER).
The registry is available through a computerized Internet database
accessible to all participating members (http://biobadaser.ser.es/
cgi-bin/regisponser/index.html). Twelve rheumatology depart-
ments from eight different cities were selected from those that
have accepted to participate in the registry on the basis of the best
availability to treat patients with spondyloarthritis. These centres
represent a broad socio-demographic spectrum of the population
treated by the Spanish Health System (Fig. 1). The average
population covered by the participating hospitals is 800000
(range 300000–1100000), and includes urban and rural zones.
All centres can be considered as a reference for rheumatic diseases
in their area. All participating rheumatologists were required to
include all patients registered consecutively that fulfilled the
inclusion criteria up to a minimum of 100 patients per centre.
The inclusion criteria were: (i) fulfilment of the classification
criteria from the European Spondyloarthropathy Study Group
(ESSG) ; (ii) blood tests available within 15 days of the
inclusion visit, and a complete radiographic study within the
previous year and (iii) agreement to complete all self-administered
questionnaires. Each patient has been assigned a random code
in the database to avoid entering personal data in the database.
The inclusion period was set at 12 months. All patients gave their
consent to participate in the study, which was approved centrally
by the Ethics Committee of the University Hospital ‘Reina Sofia’.
In each centre, there was a rheumatologist, previously trained in
a 2-day session, responsible for the patient’s assessment and data
entry in a centralized system of external monitoring to control
inconsistencies or reliability of data collected and inclusion
criteria. The socio-demographic information recorded was age,
gender, employment-related variables and habits, especially
regular exercise. An important batch of data was referred to the
diagnosis: time (year) of the onset of SpA-specific signs and
symptoms (inflammatory back pain, peripheral arthritis, extra-
axial/extra-skeletal affectation), what specific signs and symptoms
the patient had, when disease was diagnosed, how the patient
responded to each ESSG criterion, what specific diagnosis the
patient received (AS, u-SpA, PsA, IBD-associated arthritis or
ReA), clinical form of the disease (axial, peripheral, enthesitic,
extraarticular, or mixed) and whether the patient had family
history of SpA. To ascertain the degree of the disease, the number
of inflamed peripheraljoints,
Spondylitis Enthesis Score (MASES) , and the extra-articular
disease manifestations were recorded by physical examination
of the patient.
For the evaluation of the disease status, the following
anthropometrical measures were used: occipital-to-wall distance,
modified Schober’s test, lateral flexion of lumbar spine, thoracic
We decided not to include the intermalleolar distance due to
the difficulty in its measurement and to the high interobserver
variability detected during the training session. As measures of
disease status, we also included: night pain by a 0–10 visual
analogue scale (VAS); physician and patient’s global assessment
of disease activity, also by a 0–10 VAS; the Bath Ankylosing
Spondylitis Disease Activity Index (BASDAI)  and functional
capacity as scored by the Bath Ankylosing Spondylitis Functional
Index (BASFI) . Damage was accrued by the radiological
Radiology Index (BASRI) , both for spine and total (BASRI
spine þ BASRI hips). The existence of erosions, osteophytes
and protrusions in hips, were also assessed. Quality of life was
additionally evaluated by the specific questionnaire of quality of
life to spondyloarthritis (ASQoL) , and by the generic SF-12
, in which higher values indicate a better quality of life.
Lab tests included the erythrocyte sedimentation rate (ESR),
C-reactive protein (CRP) and HLA B27 status. Current treatment
corticoids, disease-modifying anti-rheumatic drugs (DMARDs)
and biological therapies were also recorded The effectiveness of
NSAIDs in relieving pain was defined as reduction of pain within
48h after introducing them or rapid worsening within 48h after
discontinuing them. All data were collected in paper data forms,
which were eventually entered into the online database, leaving
the paper support available for monitoring.
The descriptive data are presented as a mean? S.D. when referring
to quantitative variables and as absolute frequencies and
percentages when referring to the qualitative ones. Comparisons
of continuous variables between groups were made by Student’s
t-test and categorical variables by chi-square test. We calculated
correlation coefficient and intraclass correlation coefficient (ICC)
FIG. 1. Geographic distribution of the participant centres.
1310 E. Collantes et al.
by guest on May 30, 2013
with its corresponding 95% CI, considering that ICC values <0.5
represent poor or no agreement, values of 0.5–0.7 represent fair
agreement and values >0.7 represent good agreement. Statistical
analysis was performed using SPSS 11.0 (SPSS Inc. Chicago, IL,
USA). A two-sided value of P<0.05 was considered significant.
The results referred to all patients included in the registry
and classified according to their specific diagnosis
After 12 months (April 2004 to March 2005), 1385 patients were
included in the registry. Of these, 1379 patients fulfilling ESSG
criteria  were found acceptable for inclusion (six patients had
been erroneously classified). Of these, 939 were males (68%) and
440 females (32%), with an average age of 48?13 (range 12–88).
The specific diagnoses were: AS in 842 patients (61.1%), PsA
in 290 (21.0%), u-SpA in 205 (14.9%), ReA in 16 (1.2%),
IBD-associated arthritis in 13 (0.9%) and juvenile SpA in
13 (0.9%). Most patients (n¼723, 52.4%) were employed fully
at the time of inclusion, 119 (8.6%) were housewives and 498
(36.1%) were unemployed. As many as 351 (26.5%) presented
some sort of life-long occupational disability, of whom 54 (3.9%)
were temporarily disabled from working as from the day
of inclusion, 60 (4.4%) were permanently, partially disabled
(i.e. unable to perform heavy duty jobs), 76 (5.5%) were
permanently, totally disabled (unable to perform usual tasks,
but suited for others), 152 (11%) were totally disabled from work
of any kind and 9 (0.7%) were absolutely disabled, which means
that aid in daily life tasks is required.
Table 1 shows average values of age, disease duration
(from diagnosis) and diagnosis delay for all included patients
according to the diagnostic group. Also, time of evolution of the
disease defined as time from early signs/symptoms attributable
to the disease. The average age at disease onset was 29.5?12
(range 4–80yrs) for the patients as a whole, and 26.1, 39.9 and
30.1yrs for AS, PsA and u-SpA, respectively. In 23.2% of the
patients, the delay was under 1yr, whereas in 20.6% it was over
10yrs. The average age at diagnosis was 36yrs and the average
diagnosis delay was 6.5yrs, with remarkable differences between
diseases: 8yrs for AS, 3.8 for PsA and 4.5 for u-SpA.
The percentage with disease onset in childhood (age <16yrs)
was 7.0%, whereas the percentage of late onset (age >40yrs) was
18%. There was no difference in average age at disease onset
between male (25.7yrs) and female (26.9yrs) AS patients.
The earliest symptoms related to SpA were, in decreasing order:
low-back pain (52.5%), lower limbs arthritis (27.4%), sacroiliac
syndrome, defined as alternate or non-specific buttock pain
(24.4%), upper limbs arthritis (16.1%), enthesitis (7.5%), neck
pain (5.7%), coxitis (2.7%) and dactylitis (1.8%).
During the course of the disease, patients presented: inflam-
matory spinal pain (n¼1078; 78.2%), peripheral arthritis
(n¼648; 47.0%), alternating buttock pain (n¼614; 44.5%) and
enthesitis (n¼379; 27.5%). An episode of urethritis, cervicitis, or
acute diarrhoea had occurred in 26 patients (1.9%) within the
month prior to the development of arthritis.
The associated extra-articular manifestations were, in descend-
ing order: psoriasis (25%), anterior uveitis (16%), involvement
IBD (4%), prostatitis (1.2%), heart disease (1.2%), lung disease
(1.1%), renal disease (1.0%), balanitis (0.9%), palmoplantar
pustulosis (0.8%), acne conglobata (0.6%) and neurological
involvement (0.3%). A family history of SpA was present in 224
Table 2 illustrates the pattern of clinical expression and
characteristics of the disease in patients as a whole and by
diagnosis group. Regarding the clinical form of the disease, 53.5%
of the patients had mainly axial disease, 20.4% had peripheral
form, 24.3% had mixed form and only 0.7% of the patients
had a predominantly enthesitic disease. Table 2 also summarizes
Table 3 expresses data of disease activity. Most of the patients
included in the registry showed elevated values of the CRP and
ESR; in particular, patients with ReA and juvenile SpA exhibited
higher values of CRP. The average high value of the nocturnal
TABLE 2. Characteristics of 1379 patients with spondyloarthropathies at day of inclusion, by specific diagnosis
Juvenile SpA (n¼13)
Peripheral arthritis, n (%)
Enthesitis, n (%)
Uveitis, n (%)
Clinical form (axial-mixed), n (%)
Sacroiliitis, n (%)
Chest expansion (cm)
Schober modified (cm)
Occiput-to-wall distance (cm)
Fingers-to-floor distance (cm)
Cervical rotation, n (%)
Results are expressed as a mean? S.D. unless otherwise specified.
TABLE 1. Characteristics of 1379 patients with spondyloarthropathies, by specific diagnosis
Juvenile SpA (n¼13)
Men, n (%)
Age at diagnosis (years)
Age at onseta(years)
Time of evolutiona(years)
Disease duration (years)
Diagnosis delay (years)
Results are expressed as a mean? S.D. unless otherwise specified.
aFrom early signs/symptoms attributable to the disease.
Disease pattern of spondyloarthropathies in Spain1311
by guest on May 30, 2013
pain was prevalent in the AS patients, while the low value was
common in the juvenile SpA. We observed that physicians
assessed less thoroughly the activity of the disease across all
patients included than patients did.
In Table 4, we included different treatments patients received at
the time of the inclusion visit. In the case of biologicals, current
treatment was not only included, but also any other treatment
previously administered. NSAIDs had a positive effectiveness in
860 (62.4%) of the patients, showing slight differences in response
depending on the diagnosis: AS 526 (62.5%), PsA 174 (60.0%),
u-SpA 139 (67.8%) and others 21 (50%). Less than half of the
patients (n¼477; 34.6%) practised regularly some type of physical
Comparison of AS and u-SpA patients
Clinical data. As we see in Tables 2 and 3, patients with AS
had a smaller value in the Schober’s test, a smaller mobility of the
cervical lateral rotation, a greater fingers-to-floor and occiput-to-
wall distance, a higher degree of pain in the VAS and the global
assessment of the disease by the physician than the group of
patients with u-SpA, who presented better values with respect to
the thoracic expansion.
Demographic data. Figure 2 presents the results of the
comparative analysis of average values of age, age at onset and
at diagnosis, time of evolution, disease duration and diagnosis
delay between the groups of patients with AS and u-SpA. Patients
with AS had a greater time of evolution, diagnosis delay, a longer
duration of the disease and a greater age at inclusion time. We did
not find any differences between two groups concerning age at
diagnosis. Age at onset of the disease is smaller in the group of
patients with AS than in patients with u-SpA.
Disease activity. Data corresponding to the comparisons of
the variables BASDAI, BASFI, BASRI and AsQol for patients
with AS and u-SpA are expressed in Fig. 3, based on the time of
evolution divided in three sections: <5yrs, between 5 and 10yrs
and >10yrs. Average value of BASFI in patients with AS is
superior to that presented by patients with u-SpA (3.6?2.7 vs
2.6?2.5). Nevertheless, this relation is exactly opposite when time
of evolution of disease is considered to be <5yrs (2.0?2 vs
3.0?2.7). The comparison of the average values of BASDAI
Age at onset Age at diagnosisAge
Disease durationTime of evolution
FIG. 2. Comparison of average values of age, age at diagnosis, age at onset, time of evolution, disease duration and diagnosis delay of patients with AS and u-SpA.
The P-value represents significance of difference in mean values as determined by Student’s t- test.
TABLE 3. Characteristics of 1379 patients with spondyloarthropathies, by specific diagnosis.
Juvenile SpA (n¼13)
Nocturnal back pain (cm)
Patient Global Assessment (cm)
Physician Global Assessment (cm)
HLA B27 positive, n (%)
Physical component SF12
Mental component SF-12
Results are expressed as a mean? S.D. unless otherwise specified. ESR, erythrocyte sedimentation rate; CRP, C-reactive protein.
TABLE 4. Current treatment used by 1379 Spanish patients with SpA at day of inclusion.
Juvenile SpA (n¼13)
Dates are expressed as n (%). NSAIDs, non-steroidal anti-inflammatory drugs.
1312E. Collantes et al.
by guest on May 30, 2013
between both groups of patients shows the same behaviour as
with BASFI but without showing significant statistical differences
neither in the total number of patients (4.1?2.3 vs 4?2.4) nor in
any group per time of evolution. On the contrary, the average
values of BASRI total 7.4?3.9 for patients with AS and 2.3?2.0
for patients with u-SpA differ significantly among the group
as a whole and between all groups per time of evolution
(<5yrs: 4.1?2.2 vs 1.5?1.6; 5–10yrs: 4.9?2.5 vs 2.2?1.6;
>10yrs years: 8.0?4.0 vs 2.8?2.1).
Value of the patient’s opinion. We have calculated the
degree of agreement between the patient global assessment (PGA)
of the disease and the nocturnal back pain (NBP) with
BASDAI in patients with AS and u-SpA. We classified the results
into three groups (<5yrs, 5–10yrs and >10yrs), according to time
of evolution of the disease and agreement degree determined
by means of the ICC with its corresponding 95% CI. Table 5
shows the results: the agreement between PGA and BASDAI is
higher in the u-SpA group and slightly lower in the AS group,
at any time of disease duration. The agreement of the BASDAI
with NBP is higher in the u-SpA group with >10yrs of evolution
and fair in the others.
REGISPONSER is a dynamic project based upon a disease
registry. The presented results provide a reliable picture of SpA in
Spain, as the data were gathered from a large and representative
population of patients.
Disease registries are valuable instruments for clarifying aspects
of the epidemiology, outcome, effectiveness and therapeutic
tolerance of diseases, as well as their impact on socioeconomic
conditions and quality of life. Such registries are usually built
prospectively around large databases that gather information
from many centres. And in a standardized form, REGISPONSER
is the first registry designed specifically for SpA, which collects the
minimum set of data (socio-demographic, clinical, biological and
genetic) relevant to the disease. Furthermore, we have designed
a system that allows inclusion of patients from any rheumatology
department of Spain under strict quality control by means of close
monitoring and filters that detect data inconsistencies. All data
collecting forms used in the registry were agreed upon beforehand,
and they have been adapted to improve ease of use in regular
clinical practice. One of the most important achievements is
the normalization of SpA patients’ assessment and the incorpora-
tion of self-administered patient questionnaires into routine
5 -10 years
Time of evolution
>10 years 5 -10 years<5 years
>10 years 5 -10 years<5 years>10 years5 -10 years<5 years
>10 years5 -10 years
Time of evolution
Mean BASFI (cm) (95%CI)
8271 48 64712146n =
Tme of evolutioni
Mean BASDAI (cm) (95%CI)
79 7046632 11843n =
Mean BASRI-spine (95% CI)
P < 0.001
P < 0.001
P < 0.001
797046632118 43n =
Mean BASRI-total (95% CI)
P < 0.001
P < 0.001
P < 0.001
81 7148644121 46n =
Mean ASQoL (95%CI)
Time of evolution Time of evolution
FIG. 3. Comparison of average values of BASFI, BASDAI, BASRI and AsQuol of AS and u-SpA patients. The P-value represents significance of difference in mean values
as determined by Student’s t-test.
Disease pattern of spondyloarthropathies in Spain1313
by guest on May 30, 2013
clinical practice. Furthermore, each rheumatologist has individual
access to the registry, either for investigative or management
purposes, making it an effective tool for supporting the decision-
making process. It is now clear that uniformity in data collection
using similar methodologies will enhance the power and compa-
rability of data obtained from different sources. It is important
that future researchers build upon common methodologies in
order to use optimal strategies and learn about experiences in
other parts of the world.
We have not found similar published studies of patients with
SpA that can be compared with ours. In this respect, it is
interesting to emphasize that although the registry is the first
specific SpA database, we have noted that the distribution by
individual diagnoses did not differ from the reported data
in previous works. For instance, in the study that brought
forward the proposal of the Criteria for Classification of the
Spondyloarthropathies by Amor et al. , all 124 French patients
included had a distribution of diagnoses very similar to ours
(SpA 60.5%, PsA 25.8%, u-SpA 5%), and the distribution of
403 patients included for the ESSG Classification Criteria
was also similar, with perhaps less AS (AS 42%, PsA 17%, and
Using the data collected for this registry, we can define the
clinical and demographic profile of patients suffering from SpA in
Spain. We have been able to verify that the age at onset of disease
as well as the delay diagnosis in our patients are similar to those
described in previous works in different regions or countries
[29, 30]. Clinical spectrum of SpA in Spanish patients is not
significantly different from data shown in studies published in
u-SpA is an interesting subgroup of patients within SpA.
Conceptually, they are patients with characteristics of SpA that
meet SpA classification criteria but do not fit any diagnoses
proposed for the known diseases. From clinical practice, it is
known that these patients are in an early phase of AS or another
SpA but they are known as well to stay in this undifferentiated
state for many years. The registry collects data from 205 patients
with u-SpA, which we compared with those of the AS patients,
finding that the marked differences only occurred, as expected,
in the parameters that describe the severity and structural damage
of the disease. The associated manifestations were also similar
in both groups of patients. We also have compared BASDAI,
BASRI, BASFI and AsQuol, although these scales have not
yet been validated for u-SpA, as some authors considered it
acceptable . We found interesting that patients with u-SpA
were not different in disease activity (BASDAI) nor in quality
of life (SF-12) as compared with patients with AS. The only
difference between both groups of patients concerns function
(BASFI) and is significantly higher in patients with AS, although
not in the first 5yrs of disease duration. In this period, patients
with u-SpA feel that the disease limits them more than patients
with AS do. When we studied the values of the patients’ global
assessment of the disease and nocturnal pain in relation with
BASDAI in both patient groups, we found that the agreement
between PGA and BASDAI is higher in the u-SpA group and
slightly inferior in the AS group, at any time of evolution.
The agreement of the BASDAI with NBP is high in the u-SpA
group with >10yrs of evolution and fair in the other groups.
These results demonstrate that PGA in patients with u-SpA could
be used as an index of the disease activity.
At the moment, the registry is being used in 50 new Spanish
centres and 10 Latin American countries.
The authors have declared no conflicts of interest.
1 Khan MA. Update on spondyloarthropathies. Ann Intern Med 2002;135:896–907.
2 Akkoc N, Khan MA. Epidemiology of ankylosing spondylitis and related spondyloar-
thropathies. In: Weisman MH, van der Heijde D, Reveille JD, eds. Ankylosing
spondylitis and the spondyloarthropathies. Philadelphia: Mosby, 2006;117–31.
3 Collantes E, Cisnal A, Mun ˜oz E et al. Validacio ´n de criterios diagno ´sticos y de
clasificacio ´n de las espondiloartropatı ´as: Estudio multice ´ntrico en Espan ˜a. Rev Esp
4 Carmona L, Ballina J, Gabriel R, Laffon A. EPISER Study Group. The burden of
musculoskeletal diseases in the general population of Spain: results from a national
survey. Ann Rheum Dis 2001;60:1040–5.
5 Lynge E. Implication for epidemiology of disease registers. Public Health Rev
6 Zink A, Listing J, Klindworth C, Zeidler H. The National database of the German
Collaborative Arthriris Centres: I. Structure, aims, and patients. Ann Rheum Dis
7 Wolfe F. A short history of data banking in the United States from 1974 to 2003.
J Rheumatol 2004;31:41–45.
8 Mayes MD, Giannini EH, Pachman LM, Buyon JP, Fleckman P. Connective tissue
disease registries. Arthritis Rheum 1997;40:1556–9.
9 Malleson PN, Fung MY, Rosenberg AM. The incidence of pediatric rheumatic
diseases: results from the Canadian Pediatric Rheumatology Association Disease
Registry. J Rheumatol 1996;23:1981–7.
10 Bond C. South Australian Scleroderma Register: analysis of deceased patients.
11 Sokka T. Rheumatoid artritis databases. Rheum Dis Clin North Am 2004;30:769–81.
12 Kremer JM. The CORRONA Database. Clin Exp Rheumatol 2005;23:S172–77.
13 Mayes MD. The establishment and utility of a population based registry to
understand the epidemiology of systemic sclerosis. Curr Rheumatol Rep 2000;
14 Wolfe F, Sharp JT. Radiographic outcome of recent-onset rheumatoid arthritis: a
19-year study of radiographic progression. Arthritis Rheum 1998;41:571–82.
15 Christensson D, Saveland H, Rydholm U. Cervical spine surgery in rheumatoid
arthritis. A Swedish nation-wide registration of 83 patients. Scand J Rheumatol
16 Silman A, Klareskog L, Breedveld F et al. Proposal to establish a register for the long
term surveillance of adverse events in patients with rheumatic diseases exposed to
biological agents: the EULAR Surveillance Register for Biological Compounds.
Ann Rheum Dis 2000;59:419–20.
TABLE 5. Concordance between patient global assessment, nocturnal back pain and physician global assessment of diseases with BASDAI
Time of evolution
ICC¼0.69 (0.51at 0.82)
ICC¼0.51 (0.26at 0.70)
ICC¼ 0.58 (0.35at 0.75)
ICC¼0.88 (0.79at 0.93)
ICC¼0.63 (0.39at 0.78)
ICC¼0.60 (0.30at 0.78)
ICC¼0.73 (0.62at 0.82)
ICC¼0.67 (0.55at 0.75)
ICC¼ 0.64 (0.40at 0.78)
ICC¼0.78 (0.67at 0.86)
ICC¼0.62 (0.45at 0.74)
ICC¼0.56 (0.34at 0.72)
ICC¼0.74 (0.68at 0.79)
ICC¼0.66 (0.61at 0.70)
ICC¼0.43 (0.15at 0.61)
ICC¼0.85 (0.74at 0.90)
ICC¼0.72 (0.60at 0.81)
ICC¼0.41 (0.04at 0.68)
ICC, Intraclass correlation coefficient with its corresponding 95% CI; considering that a value of ICC inferior to 0.5 would indicate a poor or no agreement, of 0.5–0.7 fair and superior to 0.7 the
agreement would be good. r, correlation coefficient; PGA, patient global assessment; NBP, nocturnal back pain; PADA, physician assessment of disease activity; BASDAI, Bath Ankylosing Spondylitis
Disease Activity Index.
1314 E. Collantes et al.
by guest on May 30, 2013
17 Comite ´
BIOBADASER: registro espan ˜ol de acontecimientos adversos de terapias biolo ´gicas
en enfermedades reuma ´ticas. Rev Esp Reumatol 2002;29:292–9.
18 Gladman DD, Ritchlin C, Helliwell PS. Psoriatic arthritis clinical registries and
genomics. Ann Rheum Dis 2005;64:103–5.
19 Jarvinen P. Occurrence of ankylosing spondylitis in a nationwide series of twins.
Arthritis Rheum 1995;38:381–3.
20 Dougados M, van der Linden Sjef, Juhlin R et al. The European Spondyloarthropathy
Study Group Preliminary Criteria for the Classification of Spondyloartropathy.
Arthritis Rheum 1991;34:1218–27.
21 Heuft-Dorenbosch L, Spoorenberg A, Van Tubergen R et al. Assessment of
enthesitis in ankylosing spondylitis. Ann Rheum Dis 2003;62:127–32.
22 Garrett S, Jenkinson T, Kennedy LG, Whitelock H, Gaisford P, Calin A. A new
approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing
Spondylitis Disease Activity Index. J Rheumatol 1994;21:2286–91.
23 Calin A, Garrett S, Whitelock H et al. A new approach to defining functional ability
in ankylosing spondylitis: the development of the Bath Ankylosing Spondylitis
Functional Index. J Rheumatol 1994;21:2281–5.
24 Mackay K, Mack C, Brophy S, Calin A. The Bath Ankylosing Spondylitis Radiology
Index (BASRI). A new validated approach to diseases assessment. Arthritis Rheum
cientı ´fico de BIOBADASER. Sociedad Espan ˜ola de Reumatologı ´a.
25 Doward LC, Spoorenberg A, Cook SA et al. Development of the ASQoL: a quality of
life instrument specific to ankylosing spondylitis. Ann Rheum Dis 2003;62:20–6.
26 Ware JE, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey. Construction
of scales and preliminary test of reliability and Validity. Med Care 1996;34:220–33.
27 Gomariz EM, del Mazo AC, Guijo VP, Contreras AE, Villanueva M, Este ´vez EC.
The potential of ESSG spondyloathropathy classification criteria as a diagnostic aid
in rheumatological practice. J Rheumatol 2002;29:326–30.
28 Amor B, Dougados M, Listrat V et al. Evaluation of the Amor criteria for
spondylarthropathies and European Spondylarthropathy Study Group (ESSG).
A cross-sectional analysis of 2,228 patients. Ann Med Interne 1991;142:85–9.
29 Siepper J, Rudwaleit M. Early referral recommendations for ankylosing spondylitis
(including pre-radiographic and radiographic forms) in primary care. Ann Rheum Dis
30 Feldkeller E, Khan MA, van der Heijde D, van der Linden S, Braun J. Age at disease
onset and diagnosis delay in HLA-B27 negative vs. positive patients with Ankylosing
spondylitis. Rheumatol Int 2003;23:61–6.
31 Cardiel MH, London ˜o JD, Gutierrez E, Pacheco-Tena C, Vazquez-Mellado J,
Burgos-Vargas R. Translation, cross-cultural adaptation, and validation of the Bath
Ankylosing spondylitis functional index (BASFI) and the Dougados Fuctional Index
(DFI) in a Spanish speaking population with spondyloarthropathies. Clin Exp
Disease pattern of spondyloarthropathies in Spain1315
by guest on May 30, 2013