SLICC
Registry for Atherosclerosis in SLE
2002 Update
Dr. Anne MacKinnon
From Lupus News Fall 2002, Vol. 22,
No. 3
SLICC background
and objectives
Registry for atherosclerosis:
SLICC/RAS
SLICC/RAS activities to date
Data analysis
On the funding front
Further collaborative studies:
Neuropsychiatric SLE
Appreciation goes out to study
participants
About the author
Members of SLE International Collaborating
Clinics
This article serves as an update to the activities
of the Systemic Lupus International Collaborating
Clinics Registry for Atherosclerosis (SLICC/RAS).
SLICC background
and objectives
The Systemic Lupus Erythematosus International Collaborating
Clinics (SLICC) is an international group of rheumatologists
and lupologists from 25 centers, who have been working
together on lupus research since 1987. In the past,
they have collaborated to develop standardized outcome
measures, so that physician-researchers could better
measure and describe the course of lupus and its response
to new therapies. These outcome measures are now widely
used by lupus researchers throughout the world and
allow comparisons of patient populations among centers.
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Registry for
atherosclerosis: SLICC/RAS
It is known that women with SLE develop atherosclerosis
of the coronary arteries, or CAD, at a higher rate
and at an earlier age than the general population.
Atherosclerosis is a term that describes
the development of fatty deposits in the wall of blood
vessels. If the deposits become large enough they
can decrease or totally block the flow of blood in
the vessel. The coronary arteries are responsible
for the blood flow to the heart muscle itself.
In addition, women with SLE develop
clinical manifestations such as heart attack and angina
up to five times more often than the general population.
The SLICC group has been working on
the important area of heart disease in SLE through
the development of the Registry for atherosclerosis.
The long-term goals of this registry are to allow
researchers to determine the frequency in the population
and nature of early atherosclerotic coronary artery
disease in SLE, and to identify associated risk factors
leading to potential preventative therapies.
This Registry provides long-term follow-up
of a large diverse population of newly diagnosed patients
using standardized methods. Information collected
for each patient includes basic facts about:
- age
- sex
- race family history and lifestyle
- clinical data, including atherosclerotic outcomes
and known risk factors associated with development
of atherosclerosis
- laboratory variables
- treatment history for both SLE and atherosclerotic
complications
- disease activity and damage information.
These data, along with lab test samples,
are collected on each person annually by the various
centers, through chart review and patient interviews.
Data collection forms are then submitted
to the Registry Coordinating Center located at the
Center for Prognosis Studies in the Rheumatic Diseases,
University Health Network, in Toronto, Canada.
The Coordinating Center is responsible
for data collection, data entry, and data verification,
as well as data analyses and reporting. Blood samples
are also collected by each participating center and
shipped to the Coordinating Center for centralized
testing of specific inflammatory measures.
The Registry provides a unique opportunity
to develop a bank of blood samples and DNA from a
large and diverse SLE population. The stored DNA samples
also will allow for future testing of potential genetic
markers associated with SLE and heart disease.
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SLICC/RAS activities
to date
Enrollment & follow-up
Since the finalization of the SLICC/RAS proposal in
February 2000, all the participating centers have
developed Patient Consent Forms and have applied for
ethics approval through their local institutional
ethics review boards.
The institutional ethics review boards
are committees that are located hospitals and universities
to review all research studies involving either animals
or humans to determine if the studies should be allowed
to be performed. Approval from each local board must
be received before the study can be started in that
center.
Although this process has taken somewhat
longer than anticipated, ethics approval was completed
for all centers in the Fall of 2001, and patient enrollment
began.
To date, 331 patients have been enrolled.
Annual follow-up data have been received on 112 of
these patients, and in a few cases, second-year follow-ups
have been completed.
Data entry and verification is performed
on an ongoing basis using ORACLE software at the Coordinating
Center. And now that all centers have obtained ethics
approval and have begun actively enrolling patients,
we anticipate the rate of enrollment to increase over
the next year.
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Data analysis
The SLICC members have continued to meet twice a year
to monitor patient enrollment and collectively analyze
the data entered into the Registry. The latest analysis
of the data presented to the SLICC group in March
of 2002 included descriptive statistics of the study
population in the Registry's first 257 patients, including:
- disease activity
- disease damage
- lifestyle and family history indices
- a comparison of various therapies and lab results
at enrollment and at the patient's first annual follow-up
visit.
The demographic data obtained through
the latest analysis was based on 284 patients. Out
of the total study population of 284, 89 percent of
the patients enrolled were female and 11 percent were
male.
And, because the data collection is
taking place internationally, enrollees come from
a diverse group of racial and ethnic backgrounds:
30 percent are Hispanic, 28 percent are Caucasian
North American, and the remaining 42 percent fall
in other categories, such as Asian, Black, Native,
and Mixed. The mean age of diagnosis of SLE in this
registry is 32 years.
As data accumulate over the years, we
will be able to conduct more complex analyses, such
as:
1) examining the incidence (newly developed cases)
of atherosclerotic events in general and among the
various centers' study populations;
2) analyzing the risk factors for development of atherosclerotic
disease;
3) cross-cultural comparison of risk factors; and
4) comparison of disease features in SLE patients
who develop atherosclerosis and those who do not.
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On the funding front
The SLICC members would like to gratefully acknowledge
the following lupus patient groups in the U.S. Canada,
and the United Kingdom that have provided monetary
assistance for the development of the Registry:
o Lupus Foundation of America chapters of New Jersey,
Nashville, Western New York, Long Island/Queens, NY,
and Hudson Valley, NY
o Lupus Foundation of Ontario
o Ontario Lupus Association
o Lupus U.K.
The monies donated to date have allowed
for the purchase of materials and supplies required
for the start-up of the Registry and partial cost
of personnel at the Coordinating Center.
We are also happy to report that our
application for funding submitted to the Canadian
Institutes of Health Research (CIHR) was awarded and
began in October 2001, for a five year period, at
$125, 000 Canadian ($81, 000 US) per year. We are
currently preparing an application for National Institutes
of Health in the U.S. to be submitted in June of 2002,
to obtain additional funding for recruitment costs
at all centers.
Clearly demonstrating the commitment
of SLICC members to this project, the cost of patient
enrollment and data collection efforts at each of
the centers has been performed to date on a non-funded
basis. The projected budget required to carry out
all aspects of this study when full enrollment is
achieved at all centers is up to $500,000 in Year
Five. Naturally, this amount increases as enrollment
numbers increase, and the SLICC group will continue
to seek further sources of funding.
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Further collaborative
studies: Neuropsychiatric SLE
The SLICC/RAS provides a uniquely valuable resource
to lupus researchers.. As anticipated, further collaborative
studies have developed from this project. For example,
Dr. John Hanly from Halifax, who is also a SLICC member,
has developed an additional related study examining
neuropsychiatric manifestations of SLE (NP-SLE) that
will use information from the SLICC/RAS study in addition
to data collected on NP events. This study has recently
been funded by the Arthritis Society of Canada.
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Appreciation
goes out to study participants
The members of SLICC would also like to express their
gratitude to all the patients who have agreed to participate
in this important study.
About the Author
Dr. Anne MacKinnon is Coordinator of the SLICC Registry
for Atherosclerosis at Toronto Western Hospital and
works at the Hospital's Centre for Prognosis Studies
in the Rheumatic Disease. For more information about
how you can take part in the SLICC Registry, contact
any member of the SLICC Collaborating Clinics listed
below.
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Members of
the Systemic Lupus International Collaborating Clinics
Dr. Gráciela Alarcón,
University of Alabama, Birmingham, Alabama, U.S.A.
Dr. C. Gordon, University of Birmingham, Birmingham,
UK
Dr. Sang-Choel Bae, Hanyang University, Seoul, Korea
Dr. J. Buyon, Hospital for Joint Disease, New York,
USA
Dr. A. Clarke, Montreal General Hospital, Montreal,
Canada
Dr. M. Corzillius, Christian-Albrechts University,
Kiel, Germany
Dr. M.A. Dooley, University of North Carolina, Chapel
Hill, USA
Dr. E. Ginzler & Dr. C. Aranow, SUNY Health Science
Center at Brooklyn. New York
Dr. P. Fortin, Dr. D. Gladman and Dr. M. Urowitz,
University of Toronto, Toronto, Canada
Dr. J. Hanly, Queen Elizabeth II Health Science Centre,
Halifax, Canada
Dr. D. Isenberg, University College, London, UK
Dr. K. Kalunian, UCLA, Los Angeles, USA
Dr. M. Khamashta, Thomas Hospital, London, UK
Dr. P. Maddison, North Wales, UK
Dr. S. Manzi, University of Pittsburgh, Pittsburgh,
USA
Dr. J. Merrill, St. Lukes-Roosevelt Hospital, New
York, USA
Dr. O. Nived & Dr. G. Sturfelt, University Hospital,
Lund, Sweden
Dr. M. Petri, Johns Hopkins University, Baltimore,
USA
Dr. R. Ramsey-Goldman, Northwestern University, Chicago,
USA
Dr. Jorge Sanchez-Guerrero, National Institute of
Nutricion, Mexico City
Dr. K. Steinsson, Landspitalinn University, Raykjavik,
Iceland
Dr. T. Stoll, Schinznach-Bad, Switzerland
Dr. L. Tucker, Children's Hospital of British Columbia,
Vancouver, Canada
Dr. A. Zoma, Stonehouse Hospital, Glasgow, Scotland
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July 30, 2003
