SYSTEMIC LUPUS ERYTHEMATOSUS

Lupus Registries: Evolution and Challenges

Liang-Jing Lu, MD, PhD,* Daniel J. Wallace, MD,†
Sandra V. Navarra, MD,‡ and Michael H. Weisman, MD§

Objectives: To review the current status of lupus registries, highlight the importance and evolution of
registries in clinical lupus research, discuss substantial advances in the understanding of lupus through
the use of registries, and discuss the future role of registries in terms of opportunities and challenges.
Methods: The literature reviewed originated from the PubMed database and was limited to adult
disease in articles published before June 01, 2008. Keywords used in the PubMed search included
the following terms: systemic lupus erythematosus, registry, cohort, and database. All articles were
sorted and analyzed according to a template devised by the authors describing the different types
of registries.
Results: The most important features of a lupus registry are that they contain a large number of subjects
and reflect a relatively real world environment for lupus patients. Data obtained from the lupus registries
are essential for planning, designing, and conducting clinical lupus studies, especially those difficult,
inappropriate, or even unethical to study in randomized controlled trials. Up to now, some well-
conducted registries have received recognition for their contributions to lupus research through their
focus on different goals: epidemiology, genetics, ethnic diversity, clinical features, or outcomes. Al-
though they have evolved in design and study emphasis steadily, there are still many issues left to resolve.
Apart from the development and future direction of the lupus registry, attention needs to be applied to
normalizing the ethical and legal rules involving a lupus registry.
Conclusions: Lupus registries have demonstrated high standards and achieved much success
through decades of effort, but they are still in an active state of evolution as they address more
questions with greater clarity and sophistication.
© 2010 Elsevier Inc. All rights reserved. Semin Arthritis Rheum 39:224-245
Keywords: systemic lupus erythematosus, registry, cohort, database

S ystemic lupus erythematosus (SLE), an autoim-
mune inflammatory disease with multiple organ in-
volvement, appears to be mediated by immune dys-
regulation brought about by the interaction of genetic,
hormonal, and environmental factors (1,2). Due to a
deeper understanding of the disease itself and its manage-
ment, it is well recognized that the outcome for patients
*Visiting Scholar of Division of Rheumatology, Cedars-Sinai Medical Center, Los
Angeles, CA; and Associate Professor, Department of Rheumatology, Ren Ji Hospi-
tal, Shanghai Jiaotong University School of Medicine, Shanghai, China.
†Clinical Professor of Medicine, Cedars-Sinai Medical Center, David Geffen
School of Medicine at UCLA, Los Angeles, CA.
‡Professor, Section of Rheumatology, Clinical Immunology and Osteoporosis,
University of Santo Tomas, Manila, Philippines.
§Director, Division of Rheumatology, Cedars-Sinai Medical Center, Professor of
Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA.
The authors have no conflicts of interest to disclose.
Address reprint requests to Michael H. Weisman, MD, Cedars Sinai Medical
Center, 8700 Beverly Boulevard, Suite B131, Los Angeles, CA 90048. E-mail:
weisman@cshs.org.
224 0049-0172/10/$-see front matter © 2010 Elsevier Inc. All rights reserved.
doi:10.1016/j.semarthrit.2008.08.009
has improved during recent decades. However, SLE still
profoundly affects health status, produces disability, and
causes death—its 10-year survival is reduced by approxi-
mately 20% (2-5). Efforts aimed toward ameliorating the
reduced quality of life for lupus patients and raising the
survival rate in SLE remain a major challenge to rheuma-
tologists today. As a result, the approaches to clinical lu-
pus research have been refined continuously in recent
years, and among these, one of the most noticeable devel-
opments is the lupus registry.
The concept of the lupus registry has changed in
recent years. Well-constructed registries are not only a
useful resource for historical controls and trends in the
administration of clinical care to SLE patients, they
have also become a powerful methodological tool for
lupus research (6). In this review, we have not made an
attempt to perform a comprehensive review of all the
possible aspects of a lupus registry; rather, we have
focused on areas in which there have been advances in
L.-J. Lu et al.
Abbreviations
ACR American College of Rheumatology
LUMINA LUpus in MInorities: NAture vs. nurture
RCTs Randomized controlled trials
SLE Systemic lupus erythematosus
SLICC Systemic Lupus Erythematosus
International Collaborating Clinics
the understanding of lupus registry evolution and its
potential future direction.
METHODS
We reviewed existing literature published before June 1,
2008 through the PubMed database. In the PubMed
search, we used keywords “systemic lupus erythematosus”
and 1 of the following: “registry,” “cohort,” or “database”
with limits to “All Adult: 19⫹ years.” All relevant English
and non-English articles with English abstracts were
sorted and analyzed according to a template devised by
the authors describing the different types of registries.
Additional references were identified from the review ar-
ticles and from bibliographies for relevance.
RESULTS
Definitions
Registry, an old term, was originally defined as the place
where information was collected. The term “registry” is
defined in Webster’s English Dictionary both as the act of
recording or registering and as the record or entry itself
(7). E.M. Brooke, in a 1974 publication of the World
Health Organization, further described registries in
health information systems as “a file of documents con-
taining uniform information about individual persons,
collected in a systematic and comprehensive way, to serve
a predetermined purpose” (8,9). In a registry, subjects are
typically observed and data are collected as they present
for care (9). Therefore, a lupus registry is an organized
system for the collection, storage, retrieval, analysis, and
dissemination of information on a group of predefined
lupus patients.
However, the terms “lupus cohort” and “lupus data-
base” have often been used as alternates for a registry, even
if the 3 terms are not wholly interchangeable. A “cohort”
was 1 of 10 divisions making up a Roman legion in an-
cient Rome. A cohort is a well-defined group of subjects
or patients who have had a common experience or expo-
sure and are then followed for the incidence of new dis-
eases or events in clinical research (10). The term cohort
mostly emphasizes patients’ experience. The term data-
base is defined as an organized set of data or collection of
files that can be used for a specified purpose (7). In gen-
eral, the lupus database refers to all information collected
on a group of lupus patients derived from the registry.
The underlying meaning of the term database tends to
225
refer to the data itself. Therefore, the term registry has a
more comprehensive definition than either cohort or da-
tabase; it may contain both of the latter items.
Purposes of a Registry
There are multiple varieties of lupus registries created or
organized for different purposes. However, according to
our design in this review, we will classify lupus registries
into 3 types: administrative registries designed to collect
data from SLE patients including demographics, medical
histories, and simple follow-up information; cross-sec-
tional registries created to collect data coming from SLE
subjects or samples assessed at 1 point in time; longitudi-
nal registries mainly organized to collect data coming
from SLE subjects followed over time with continuous
and repeated monitoring. During its initial stages, the
types of lupus registries were predominantly administra-
tive and cross-sectional. Since the 1970s, longitudinal
study registries for lupus have generated a great deal of
new knowledge about SLE patients (6,11-13).
Rationale for Implementing a Registry
An extremely important feature of the lupus registry is
that it contains a large number of subjects and may reflect
a relatively real world situation for lupus patients. Data
obtained from the lupus registries appear to be essential
for planning, designing, and conducting clinical research
in SLE subjects. In particular, lupus observational studies
(nonrandomized such as cohort studies, case-control
studies, and cross-sectional surveys) should be based
within lupus registries (9). Although most researchers as-
sume that randomized controlled trials (RCTs) are on a
higher end of the validity scale compared with observa-
tional studies, a controversy was generated by 2 studies
published in the New England Journal of Medicine that
found no difference in estimates of treatment effects be-
tween RCTs and observational trials (14,15). Regardless
of which viewpoint makes a stronger argument, we can
deduce from the dispute that high-quality observational
studies can produce equally reliable results (16,17).
There may be circumstances where RCTs may be in-
appropriate or even unethical (6), and registry-based ob-
servational studies might be able to resolve this dilemma.
For example, researchers faced an awkward situation
when adopting a RCT design to study the effects of smok-
ing and hormone replacement therapy on SLE disease
activity and outcome. Data from the Toronto lupus da-
tabase indicated that “hormone replacement therapy was
not associated with increased flares in SLE” (18) and that
“smoking appeared to decrease the efficacy of antimalarial
therapy in cutaneous lupus” (19). Furthermore, although
the efficacy of newer treatments must await the results of
RCTs, important observations on current treatments can
be made from longitudinal registries (6). Many important
and useful clinical discoveries concerning older drugs
such as antimalarials or cytotoxic agents were made
226
through several lupus registries. Moreover, observational
data from longitudinal registries can be assumed to apply
to subpopulations not studied in RCTs (9). In addition,
the superiority of a well-constructed lupus registry is thor-
oughly reflected in some studies, such as risk factors, clin-
ical laboratory correlations, prognosis, outcomes regard-
ing physician practice behavior, and other clinically based
decisions that are difficult to study in RCTs.
The most important advantage of observational studies
based on lupus registries is the collection of study data
from nonexperimental circumstances (6,9). As Dr. Fein-
stein previously suggested, the resolution of future issues
in clinical management would have to come from “anal-
ysis of events and observations that occur in nonexperi-
mental circumstances during the interaction of nature,
people, technologic artifacts, and clinical practitioners”
(20). Further, it is possible to misinterpret the effects of
some specific interventions because of uncertainties asso-
ciated with artificial experimental circumstances in
RCTs. The estimates of effect might be larger in random-
ized trials if the intervention provided is better tolerated
than that in nonexperimental circumstances, assuming
that this is the case for the treatment group and not the
control group (21-24). In addition, strict eligibility crite-
ria may select for subjects with a higher capacity to benefit
from treatments, resulting in overestimates of effect in
randomized in compared with nonrandomized trials with
less strict eligibility criteria (21-24). Therefore, in similar
fashion to RCTs, lupus registries also play important roles
in lupus clinical research (Table 1).
Table 1 Rationale for a Lupus Registry
⽧ Lupus registries can provide detailed information
derived from large numbers of lupus patients.
⽧ Study data from lupus registries generally come from
nonexperimental circumstances and may reflect a
relatively real lupus world (9).
⽧ Most lupus observational studies are based on lupus
registries (9).
⽧ Lupus observational data from registries can answer
certain questions that are inappropriate or unethical
to be solved by RCTs (6).
⽧ Long-term efficacy and safety observations on
currently used interventions can be made in
longitudinal registries (6,9).
⽧ Observational data from longitudinal registries can
be generalizable to a wide range of lupus
patients (9).
⽧ Studies such as risk factor analysis, clinical laboratory
correlations, and prognosis outcomes reflecting
physician practice behavior and decisions may be
more appropriately studied from registry data as
opposed to RCTs (6,9).
RCTs, randomized controlled trials.
Lupus registries
Caveats in Using a Registry
It is important to mention that observational data from a
registry cannot take the place of RCTs especially in areas
in which an active intervention is intended to change the
outcome of a certain disease. It is evident that a clinical
research development strategy should be selected based on
the quality of the evidence provided by each design, the
burden of data collection, and the cost that is imposed on
the study in question (9). In addition, as in RCTs, rigor-
ously applied ethical concerns should accompany the de-
velopment and use of all observational trials based on
registries.
Principles and Components
for Creating a Lupus Registry
To a large extent the high quality of observational studies
depends on the design of registries. A well-designed reg-
istry can provide comprehensive, high-quality data,
which would in turn enable better understanding of cur-
rent disease course and practice. In the field of lupus re-
search, this has been confirmed by the development and
contributions of some well-conducted prospective longi-
tudinal registries studies, such as the LUMINA (LUpus in
MInorities, NAture versus nurture) Cohort (11) and the
Toronto Lupus Database (6). Considerable concern was
raised by the investigators from these large patient regis-
tries that RCTs were unable to address and resolve certain
important issues. These well-designed lupus registries
strictly complied with some important principles of de-
sign such as specific inclusion criteria, case– control de-
sign when appropriate, adjustments for differences at
baseline, rigorous definition of case ascertainment, careful
clinical observation and recording, as well as appropriate
statistical methodology (6,11,12). Although each registry
has its own characteristics and particular emphasis, the
components of lupus registries are commonly encoun-
tered and conform to the scope of those items displayed in
Table 2.
Current Status of Lupus Registries
Recently, some registries have received recognition for
their contributions to lupus research by focusing on 1 or
more of the following goals: identifying genes that deter-
mine susceptibility to the disease and groups at high risk,
determining the processes of health care and the different
factors that affect the outcome of lupus, studying the di-
versity of lupus in different ethnic groups, and describing
the epidemiological and/or clinical features of SLE pa-
tients (6,11-13).
In reality, administrative registries have not been lim-
ited to administration. For example, some population-
based administrative registries have been used to study
lupus epidemiology, disease influence from risk factors,
and some simple outcomes analysis (9). An ideal admin-
istrative lupus registry optimal for epidemiological studies
L.-J. Lu et al. 227

Table 2 General Components of a Lupus Registry

General data Demographics, socioeconomics, social and occupational history, insurance, education, acculturation,
family history, environmental considerations, smoking, menstruation, contraception, primary care
collaboration, compliance, time inventory of serial follow-ups.
Clinical features Symptoms, signs, laboratory findings, imaging abnormalities, tissue findings involving organs, ACR
criteria, medications.
Comorbidities Infections, thrombosis, gonadal failure, osteonecrosis, atherosclerosis, malignancy, osteoporosis,
fracture, diabetes mellitus, obesity, hypertension, fibromyalgia, pregnancy, other connective tissue
diseases.
Outcomes Lupus activity, flare, damage, health status, disability, hospitalizations, response to therapies, serious
adverse events, death, physician’s global assessment, patient self-report.
Exploratory items Genetics, new biomarkers.
Specimens Tissue, serum, urine, cerebrospinal/pleural fluid, DNA, RNA.
ACR, American College of Rheumatology; DNA, deoxyribonucleic acid; RNA, ribonucleic acid.

should include lupus groups with validated and accepted
tools performing active surveillance from the representa-
tive geographic areas (25). For example, the ongoing Cen-
ters for Disease Control and Prevention–sponsored SLE
registry, directed by McCune and Lim, will supervise a
large lupus population based on several million inhabit-
ants in Michigan and Georgia (26). However, an active
surveillance lupus registry is fairly difficult to manipulate
and maintain and requires considerable time and funding
due to the complexity and rarity of SLE.
As a result, some rheumatologists and lupus experts
have resorted to utilizing existing administrative regis-
tries, not necessarily specific to lupus, to study the epide-
miology of SLE. The registries involved include the Amer-
ican Rheumatism Association Medical Information System
database (US) (27-29), the National Center for Health Sta-
tistics (US) (30), the Nationwide Inpatient Sample—the
largest hospitalization database (US) (30), State Hospitaliza-
tion Databases (US) (31), the General Practice Research Da-
tabase (United Kingdom) (32-34), the German Rheumato-
logic Database (Germany) (35,36), the National Database of
Patients Visiting Rheumatologists (Netherlands) (37), the
Standard Diagnosis Register of Rheumatic Diseases
(Netherlands) (37), the Physician Billing and Hospital-
ization Databases (Canada) (38), and so on. Studies based
on these administrative registries have made use of data on
the incidence, prevalence, ethnicity, mortality, health
care, burden of illness, and demographic and clinical
characteristics that classify patients with SLE.
The above-mentioned large-scale registries not specific
to lupus often include systemic illness-related diagnostic
codes. However, not all signs, symptoms, or laboratory
findings lead to a diagnosis of SLE. Because of this short-
coming, there may be insufficient data to determine
whether or not all cases fulfill the American College of
Rheumatology (ACR) criteria. This missing information
may likely result in an underestimate of the total number
of SLE patients (30-38). As such, studies based on admin-
istrative registries may not be considered sensitive enough
by more precise standards. Bernatsky and coworkers (38)
estimated SLE incidence and prevalence using multiple
sources of population-based administrative data and eval-
uated the sensitivity and specificity of case ascertainment
methods. They concluded that SLE incidence and preva-
lence estimates differ considerably in administrative reg-
istries depending on the case ascertainment approach. In
the absence of gold standards, statistical modeling can
provide sensitivity and specificity estimates for different
approaches. Thus, administrative registries may be useful
sources of information for observational studies of SLE
patients; nevertheless, 1 must take into account strategies,
data sources, and the appropriateness of statistical meth-
ods used.
Highlighting the value of such registries is the recent
investigation of the onset and progression of autoantibody
development before SLE is clinically diagnosed utilizing an
administrative registry such as the U.S. Department of De-
fense Serum Repository (39,40). This repository contains
data and samples on approximately 30 million service
personnel taken at baseline. Within this population, 130
individuals with SLE were identified. Data on these indi-
viduals indicated that anti-double-stranded DNA anti-
bodies were found later than antinuclear antibodies and
earlier than anti-nuclear ribonucleoprotein antibodies
with a mean onset of 2.2 years before diagnosis. Anti-
Smith antigen appeared shortly before clinical diagnosis,
suggesting a peak of autoimmunity that resulted in clini-
cal illness. In summary, important information gained
from this study reveals that future predictions of the clin-
ical features of SLE are possible through assessment and
monitoring for various lupus autoantibodies (39). Al-
though it is necessary to ascertain how comprehensively
collected were the clinical features of those 130 SLE pa-
tients, this interesting and valuable study is a successful
paradigm on how to efficiently utilize an administrative
registry.
Currently, the largest majority of lupus registries are
used mainly to observe SLE patients with respect to risk
factors, clinical features, therapeutic effectiveness, prog-
nosis, and outcomes. Among these, the Toronto Lupus
Database is 1 of the most outstanding and productive
lupus registries. Drs. Urowitz and Gladman established a
cohort of SLE patients in 1970 that have been followed
prospectively for 38 years (6). Members of the cohort have
228 Lupus registries

Table 3 Listing of Some Existing Lupus Registries from Different Continents as Examples
Related Articles (References
originated from PubMed
Location Director Major Purposes before June 1, 2008)
LUMINA Cohort Alabama, USA Alarcón GS Race difference; 45,64-119
outcomes
Hopkins Lupus Cohort Maryland, USA Petri M Outcomes 48,52,120-158
NIAMS Lupus Registry Oklahoma, USA Harley JB Genetics 159-189
CSMC Lupus Cohort California, USA Wallace DJ, Outcomes; epidemiology 190-214
Weisman MH
UCSF Cohort California, USA Criswell LA Genetics; outcomes 215-230
Pittsburgh Lupus Pennsylvania, USA Manzi S Outcomes; genetics 49,50,231-246
Databank
University of North North Carolina, Dooley MA Outcomes; epidemiology 247-262
Carolina Lupus USA
Nephritis Registry
SLEIGH South Carolina, Gilkeson GS Race difference; genetics; 159,161,247,238,252-265
USA outcomes
Toronto Lupus Ontario, Canada Urowitz MB Outcomes 5,41,46,47,266-362
Database
Mexico City Cohort Mexico City, Alarcón-Segovia D Outcomes 363-379
Mexico
University College London, UK Isenberg DA Outcomes 380-394
London Hospitals
Lupus Cohort
Birmingham Lupus Birmingham, UK Gordon C Outcomes; epidemiology 395-408
Cohort
Renji Hospital Lupus Shanghai, China Chen SL Outcomes; genetics 409-425
Database
Lupus Database of Manila, Philippines Navarra SV Outcomes 426-429
University of Santo
Tomas
Tock Seng Hospital Singapore Chng HK Outcomes 430-453
SLE Study Group
SLICC Worldwide An international Outcomes 59-63,312,361,362,454-462
group from 25
centers
Euro-Lupus Cohort Europe A group from 7 Outcomes; epidemiology 13,463,464
European
countries
GLADEL Cohort Latin American 34 centers from 9 Outcomes; epidemiology 465-468
Latin American
countries
The listing above is representative of lupus registries but is not inclusive of all of them.
LUMINA, Lupus in Minorities: Nature vs. nurture; NIAMS, National Institute of Arthritis and Musculoskeletal and Skin Diseases; CSMC,
Cedars-Sinai Medical Center; SLEIGH, SLE in Gullah Health; UCSF, University of California, San Francisco; SLICC, Systemic Lupus Erythem-
atosus International Collaborating Clinics; GLADEL, Grupo Latino Americano de Estudio del Lupus or Latin American Group for the Study of
Lupus.

been evaluated with clinical and immunological measures
according to a rigorous, predetermined protocol per-
formed at defined intervals (6). Since its inception, this
extensive longitudinal registry has included more than
1200 patients and has produced more than 100 published
articles (Table 3). Some findings from the registry have
revolutionized the way lupus is diagnosed and managed.
For example, in 1974, the longitudinal observation first
revealed the bimodal mortality pattern of SLE (41). That
is, early mortality is associated with lupus disease activity
and infection, whereas late mortality is associated with
atherosclerosis. Subsequently, premature accelerated ath-
erosclerosis in SLE patients independent of traditional
risk factors for cardiovascular disease has been confirmed
by other observational cohorts and case– control studies
(42-51). At the present time, the study of premature ath-
erosclerosis in SLE has become 1 of the areas of emphasis
in the field of lupus research.
Another well-known outcome-oriented prospective
longitudinal lupus registry is the Hopkins Lupus Cohort
headed by Dr. Michelle Petri (12,52). The cohort is in its
20th year, with 1500 participants who are seen quarterly
L.-J. Lu et al.
for assessments of disease activity, organ damage, and
health status (12). New information from the Hopkins
Lupus Cohort study, particularly on pregnancy, athero-
sclerosis, antiphospholipid antibodies, and flares in lupus,
has greatly expanded our knowledge base (12). In addi-
tion, there are many more lupus registries (some are dis-
played in Table 3) with the goal of understanding how the
outcome of lupus patients can be improved around the
world. These registries encompass a broad array of risk as-
sessment and outcome areas including genetics, environ-
ment, demographics, clinical-laboratory features, prognosis,
organ-specific outcome, medication use, and quality of life
that have contributed to improvements in the outcome of
this disease.
The variable phenotypic expression of disorders such as
lupus among individuals of different ethnicities can be stud-
ied successfully with registries. The LUMINA Cohort is a
well-known lupus registry designed to delineate the influ-
ence of ethnic factors on SLE outcome (11). LUMINA is an
American-based, multiethnic (Hispanic, African American,
and white), early lupus cohort established through the vi-
sionary leadership of Dr. Graciela Alarcón. It is designed to
assess the effects of genetic, sociodemographic, and be-
havioral factors on the course and outcome of SLE in 3
ethnic groups. LUMINA includes detailed data on socio-
economic, demographic, clinic, immunologic, immuno-
genetic, functional, psychological, and behavioral vari-
ables as well as serum and DNA samples secured from more
than 600 patients (11). This rich longitudinal registry is an
invaluable resource for determining the many different fac-
tors that can affect the outcome of lupus among individuals
from different ethnic groups. However, a major problem
with the LUMINA Cohort is that patients are only assessed
annually, which can accurately determine the damage index,
but is of little value in assessing disease activity. Presently,
approximately 60 peer-reviewed published articles have orig-
inated from LUMINA (Table 3). The information derived
from the articles may have an impact on the development
of policies aimed at eliminating health disparities in the
U.S. (11).
A number of genetic associations with SLE have been
established and confirmed by different lupus cohorts. To
further outline the genetic background of lupus, some
registries include the collection and banking of SLE ped-
igrees (53). For instance, in early 1996, in an attempt to
identify genes that determine susceptibility to the disease,
National Institute of Arthritis and Musculoskeletal and
Skin Diseases established the Lupus Registry and Repos-
itory to study people with lupus and their families (53).
Sestak, et al direct this extensive project, which collects
clinical, demographic, and laboratory data on patients
with lupus and their families. Blood, cells, and DNA from
these individuals are stored in the Lupus Repository for
genetic testing. Hitherto, a number of lupus-associated
genetic loci have been discovered and confirmed from this
registry (53,54).
229
To overcome the inherent biases of a single center registry
to address clinical research in SLE, some wide-scale multiple
center registries, such as the Systemic Lupus Erythematosus
International Collaborating Clinics (SLICC), Euro-Lupus
Project, Grupo Latino Americano de Estudio del Lupus, or
Latin American Group for the Study of Lupus (Table 3),
have been established. Among these, the SLICC is worth
mentioning. SLICC is an international group of rheuma-
tologists and lupus experts from 25 centers who have been
working together on lupus research since 1987 (55). In the
past, they have worked together to develop standardized out-
come measures (eg, SLICC/ACR Damage Index, etc), so
that physician-researchers could better measure and describe
the course of lupus and response to new therapies (55-57).
The SLICC/ACR Damage Index is widely used by lupus
researchers throughout the world and allows for comparisons
of patient populations between centers (58). Recently, a se-
ries of interesting results on risk factors and outcomes of
neuropsychiatric events (59-61) and coronary artery disease
(62,63) in SLE were presented based on data from SLICC.
DISCUSSION
Evolution of Lupus Registry
The appearance of prospective well-designed longitudinal
lupus registries is part of the evolution and development
history of lupus research. These have evolved not only in
terms of design but also in terms of content (6,11-13).
Part of this evolution has included observational studies
not just limited to retrospective analyses but including
prospective designs that have produced more reliable re-
sults (6). These registries represent a shift from cross-
sectional studies to longitudinal ones, thereby raising the
validity of the data gathered. In addition, the range of
collected data were enlarged to include demographic and
clinical data as well as serum and DNA samples; biological
samples for the conduct of basic science studies without
the corresponding meticulously collected clinical data
lacks value. Finally, using different software packages, lu-
pus registries transferred digitized information from pa-
perwork to the internet in real-time. In conclusion, lupus
registries now look more like study methods than instru-
ments.
With regard to content, the emphasis of studies based
on lupus registries has evolved. The clinical pattern of
lupus has changed from an acute fatal disease to a chronic,
treatable, and controllable condition with the overall
mortality decreasing dramatically with patients living
longer lives and dying of chronic comorbid complications
instead of active lupus (5,41,361,469,470). Chronic
complications, either treatment- or patient-related, have
become the outstanding factor to address to reduce mor-
tality and further improve quality of life in SLE. At the
present time the main study emphasis of lupus registries has
shifted from organ involvement to chronic complications
such as accelerated atherosclerosis, dementia, osteoporosis,
avascular necrosis, thrombosis, tumor development, fibro-
230
myalgia, and fatigue (2,6,11,12,470). Concerns have also
shifted the focus away from disease activity to the irrevers-
ible damage associated with disease and the health status
of lupus patients. Although these registries have reached
high standards and achieved much success through de-
cades of effort, they are still in an active state of develop-
ment.
What Can We Do Further?
The power of lupus registries lies in the large number of
patients and the gathering of “real-world” information.
Although the current multicenter lupus registries are in-
valuable assets for SLE research, and data obtained are
more reasonable and are closer to the actual circumstances
of lupus patients, the existing multicenter lupus registries
are still far from optimal. Evaluating the list of registries
from SLICC, Latin American Group for the Study of
Lupus to the Euro-Lupus Project, these multicenter reg-
istries mainly comprise the top centers in the world, in-
cluding specialists with strong backgrounds in lupus re-
search (13,59-63,312,361,362,454-468). Patients from
these centers may have certain specific characteristics such
as higher socioeconomic status or greater disease severity,
adding another layer of complexity and perhaps leading to
skewed results. Therefore, observational data are likely to
be biased by such center-to-center cooperation.
To further optimize the design of the lupus registry,
there are 2 kinds of strategies that can be considered. One
strategy requires a new collaboration model comprising
components from different levels of health care, such as
private practices and university and nonuniversity hospi-
tals in certain geographic areas. Another strategy might
include the screening and active supervision of the inclu-
sion of lupus patients, or proto-lupus patients, as well as
autoimmune identifiers in certain geographic areas. These
strategies would create, as close as possible, a population-
based prospective longitudinal lupus registry, reflecting
lupus in the real world. As the feasibility and maneuver-
ability of these strategies evolve, collaboration of rheuma-
tologists, statisticians, epidemiologists, and other deci-
sion-makers is required.
In the studies of ethnic differences, international coop-
eration is extremely important. For example, to diversify
the LUMINA Hispanic patient group and make it more
comparable to the U.S. Hispanic population, the Hispan-
ics from Puerto Rico were later added into the cohort
(11). Urike and coworkers point out that even if very
strict definitions of ethnicity are used, it is very likely that
the groups in LUMINA are not truly homogeneous, lead-
ing to significant residual confounding (11). The direct
comparison between different ethnic population-based
native-born lupus cohorts may be a more acceptable al-
ternative in future.
For instance, data from a study conducted by Chen
(412) indicated that there are no obvious differences in
lupus prevalence or severity between white and Chinese
Lupus registries
patients. The severity of disease may be more closely re-
lated to socioeconomic status and the timeline of diagno-
sis and treatment. However, it has been mentioned re-
peatedly that there are more SLE patients with severe
disease in Asia (2), even if there are little observational
data from the contrast between Asians and Caucasians to
prove this contention (382). In any case, it may be neces-
sary to delineate the disparity between the SLE patients
from Asian and white sources directly through coopera-
tion between international lupus registries.
Lupus registries are also of primary importance in ap-
proaches to develop and validate new assessments of lupus
outcomes. Measures of disease activity, damage, and
health status of SLE (such as Systemic Lupus Erythema-
tosus Disease Activity Index, British Isles Lupus Assessment
Group, SLICC, Systemic Lupus Activity Questionnaire, etc)
have now been successfully used in investigator-initiated lu-
pus research studies. However, none of these assessment
tools are perfect as each has different strengths and weak-
nesses (471). A painful transition from clinical observation to
clinical research will remain in the development of these
measures. As Dr. Petri said, “Certainly they can be im-
proved on, and should be. Ultimately, much can be said
for simple trial designs with straightforward outcomes”
(4). Nevertheless, to produce valid observations, it is im-
portant to standardize the means of patient and disease
assessment. Discordance on the assessment measures of
lupus outcomes has long inconvenienced rheumatologists
(12). This issue has become more important due to the
explosion of requirements for multicenter collaborations
and comparisons.
Thus, a simple core-set of standardized measures of
outcome of SLE that can be easily integrated into routine
care and clinical trials must be developed at a consensus
conference and validated with acknowledged lupus co-
horts such as SLICC. For example, the National Institutes
of Health Foundation, lupus patient-support organiza-
tions, Lupus Clinical Trials Consortium, and corporate
contributions (eg, from International Business Machines
Corporation) are working to constitute a core set of data
elements and create a national, uniform lupus database.
The ultimate goal is the integration of worldwide obser-
vational lupus registries to supplement clinical and labo-
ratory research in SLE.
Well-done lupus registries are not only ideal resources
for the selection of random samples of patients for clinical
trials, but observational studies based on them are impor-
tant complements for clinical trials of therapeutic agents.
It is axiomatic that efficacy and safety in clinical trials not
be generalized to subgroups of patients not included in
the study population (9). Differences between results from
clinical trials and clinical practices have been confirmed in
some studies (472,473). In addition, the observational time
period is much more limited in clinical trials.
Lupus registries can be very useful for long-term track-
ing of the impact of treatments in real-world clinical prac-
tices. To approve a new drug for lupus, the Food and
L.-J. Lu et al. 231

Table 4 Suggestions for Creating a Common Lupus Registry

⽧ The specific research purpose will guide a lupus registry design, identification of data needed, and definition of the
target population.
⽧ Subjects screening criteria for most lupus registries are often broader than RCTs to enable generalization of
conclusions from clinical research.
⽧ Choice of data elements should be guided by parsimony, validity, and a focus on achieving the purpose of the lupus
registry.
⽧ Besides primary data collected for direct purpose of a registry, secondary data linked to the registry including medical
records systems, institutional databases, administrative health insurance claims data, death and birth records, census
databases, and related existing registry databases are required.
⽧ The data should be collected in a naturalistic but uniform manner for every patient.
⽧ Goals for recruitment, retention, and follow-up of lupus patients should be explicitly laid out and continuously
evaluated.
⽧ Critical ethical and legal considerations, for example, IRB, data access, publication rights, data ownership, and other
administrative aspects should guide the development and use of the lupus registry.
⽧ It is important to develop a plan for detecting, processing, and reporting AEs for a lupus registry.
⽧ The analytical plans and interpretation of registry data should be provided so that conclusions can be understood in
the appropriate context.
⽧ Requirements for quality assurance should be defined during the registry’s inception and creation to protect against
bias and errors.
RCTs, randomized controlled trials; IRB, Institutional Review Board; AEs, adverse events.

Drug Administration Guidance Document lists a series of
conditions to be satisfied (474). In this regard, lupus reg-
istries provide an advantage in offering more robust effi-
cacy and safety data obtained from longer time periods.
Furthermore, more observations and adverse reactions
may be quantified and attributed. This can be impor-
tant when weighing the strength of evidence in making
risk– benefit comparisons and achieving claims in ap-
proved labeling. In addition to clinical efficacy and
safety, lupus registries can be used to assess the cost
effectiveness of a broad variety of promising interven-
tions (9). We can design lupus registries to collect cost
and effectiveness data to examine the incremental ben-
efit of a particular intervention and the costs associated
with achieving that benefit. Furthermore, lupus regis-
tries hold the promise of uncovering new indications
and unknown effects of drugs not previously recog-
nized or analyzed.
Lupus registries will facilitate the interaction between
basic research and clinical medicine, thus potentially ful-
filling the role of a mediator of translational medicine.
Aims of this phase of the lupus registry research have been
formulated to gather not only clinical, laboratory, phar-
maco-, and socioeconomic data, but also biospecimens
such as tissue, sera, urine, DNA, and RNA in patients
with SLE (6,11,12). With the accumulation of longitudi-
nal follow-up data and all manner of specimens, we can
presume there will be breakthroughs in outcome-related
studies and improvements in clinical diagnosis and ther-
apy. Classification of SLE may be an important study
target for lupus registries since SLE is the most diverse of
the autoimmune diseases. It would be important as well as
interesting to classify SLE patients according to the new
findings discovered in the areas of immunology and mo-
lecular genetics elucidating more information relevant to
prognosis.
Nonetheless, there are many issues left for lupus regis-
tries to resolve including predictors, outcomes, interven-
tions for organs involved, chronic complications, identi-
fying the primary characteristics of patients who have
resistant disease, identifying rare manifestations of lupus,
and characterizing the influence of autoantibody profiles
on disease manifestations and their severity. Much
ground needs to be covered in normalizing the rule of
lupus registry ethics, issues related to data sharing, pri-
vacy, authorship, governance, and uses of repository ma-
terials, approaching lupus registry software and compati-
bility issues, exploring the fairness and ethics of funding
resources, and so forth. We should bear in mind that a
well-done longitudinal lupus registry not only needs
large numbers of lupus patients but also those subjects
that represent different levels of health care. To make
the results of observational studies more generalizable,
lupus patients should be observed as they present for
care, and the data collected should generally reflect
whatever measurements a provider customarily uses.
Herein, Table 4 presents detailed suggestions obtained
and modified from reference 9 for creating a common
lupus registry.
Lupus registries have become a science and well-done
lupus registries will play a more important role in SLE
research due to their ability to provide meaningful real-
world information to promote the best practices in health
care. Simultaneously, lupus registries allow better com-
munication between rheumatologists, epidemiologists,
and health supervisors, providing them with an optimal
cooperative platform. However, there are still many chal-
lenges to face.
232
ACKNOWLEDGMENT
Dr. L.J. Lu was supported by grant from the National Natural
Sciences Foundation of China (Grant 30671946).
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