Current management of patients with SLE is usually stratified by the degree of internal organ involvement; treatment strategies include a variety of immunosuppressive medications, used alone or in combination, that are limited both in their efficacy and by significant potential toxicities. There is an unmet need for improved treatment of inflammation in this patient population. The all-cause mortality in SLE has greatly improved but there is significant morbidity and increased mortality due to accelerated atherosclerotic vascular disease. Further, premature cardiovascular disease risk may be as high as 50-fold when compared to matched controls and is not explained by the traditional risk factors. The underlying pathogenic mechanisms involved in endothelial dysfunction leading to premature atherosclerosis in lupus remain elusive. Advances in immunosuppression and close monitoring of patients have decreased organ damage in lupus, but no drug to this date has proven to abrogate atherosclerosis development in SLE. Identifying a drug that has immunomodulatory effects and is also vasculo-protective is an unmet need in this disease.
The Lupus Clinical Research Program at NIAMS conducts innovative translational and clinical research into the causes, treatment, and prevention of SLE. The Lupus Clinical Research Program maintains a comprehensive clinical database of SLE patients that includes patient demographics, SLE disease activity and damage indices, patient-reported outcome tools, and other data for phenotyping our cohort. The SLE Natural History and Pathogenesis protocol serves as a pivotal resource for understanding and characterizing the heterogeneity of this disease, providing biological specimens and outstanding clinical phenotyping to various intramural and extramural labs involved in lupus research. This collaborative research model has led to several biomarker discoveries and scientific hypothesis generation. These discoveries have been translated into clinical trials by the Lupus Clinical Trials Unit.
The Lupus Clinical Trials Unit (LCTU) of the Lupus Clinical Research Program develops and implements clinical research protocols and conducts high impact, innovative clinical research based largely on the discoveries resulting from NIAMS IRP translational research.
- Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus Erythematosus; a Phase Ib Clinical Trial and Associated Mechanistic Studies.
- The Role of PPAR-gamma Agonists in immunomodulation and Vascular Prevention in SLE (PPAR-SLE).
- Natural history of vascular damage and atherosclerosis development in SLE.
- Deep immuno-phenotyping and systematic study of serum proteins and gene expression in SLE.
- Aerobic Exercise in Women with Systemic Lupus Erythematosus (Exercise SLE).
- Genomic Effects of Glucocorticoids in Patients with Systemic Lupus Erythematosus.
Quality improvement (QI) is a framework used in health care to improve patient care, outcomes, and the development of health care professionals. It has been shown to improve morbidity and mortality. The LCTU has implemented several QI projects for our patient cohort.
- A health maintenance section has been incorporated into all progress notes to touch on areas affected by SLE and the drugs that treat this disease.
- Patients with lupus are at a higher risk of osteoporosis because of chronic inflammation and the adverse effects of therapeutic medications, including glucocorticoids. We are working together with an interdisciplinary team to implement a standardized template for outpatient visits that incorporates osteoporosis assessment and management guidelines.
- A specific sun protection brochure was created and provided to patients as education regarding SLE and photosensitivity.
- Reproductive health is an important topic and should be a shared decision-making process between SLE patients and providers. We are currently working on implementing reproductive health counseling during patient visits.
- Patient-reported outcome surveys are completed at every visit to help clinicians better understand the patient's perceived health status and empower the patient in their health care process.
For more information, please contact Jun Chu (Jun.Chu2@nih.gov).
DC Lupus Consortium
In 2016, The Lupus Clinical Research Program established The DC Lupus Consortium (DCLC), a collaborative network of rheumatologists, nephrologists, physiatrists, and other health care providers interested in lupus clinical research in the Metropolitan DC area. The purpose of the DCLC is to promote partnerships and referrals to the NIAMS Lupus Clinical Research Program and collaborations with local and regional clinicians caring for patients with lupus.
NIH scientists, researchers, patient advocacy groups, and physicians both within and outside of NIH are welcome to join. To learn more about upcoming DCLC events, please contact Elaine Poncio (email@example.com) or Isabel Ochoa (firstname.lastname@example.org) to be added to the mailing list.
For over 25 years, the NIH has yielded a vast wealth of knowledge about this disease and made great strides in lupus clinical research. To recognize the accomplishments and milestones, a special 25th-anniversary event at the fourth annual meeting of the DCLC featured perspectives from research participants and presentations of current and future lupus research activities at the NIH.
Join Us for the Next DCLC
NIH scientists, researchers, patient advocacy groups, and physicians both within and outside of NIH are welcome to join this consortium. If you would like to learn more about upcoming DCLC events, please contact Elaine Poncio (email@example.com) or Isabel Ochoa (firstname.lastname@example.org) to be added to the mailing list.
ClinicalTrials.gov Identifier: NCT04496960
Sjogren's syndrome (SS) is a systemic autoimmune disease that often involves multiple organs of the body. The disease primarily affects females and manifests as inflammation and destruction of glands leading to dryness of mouth, eyes, skin, throat, and vagina. Additionally, patients may experience profound fatigue, widespread muscle pain, and swollen and painful joints. Researchers are trying to find new, more effective, and safe treatments for SS. The objective of this study is to evaluate the safety and tolerability of tofacitinib, an oral janus kinase inhibitor, in people with SS.
ClinicalTrials.gov Identifier: NCT04690816
Viral infections such as COVID-19 may lead to flare-ups in people with systemic autoimmune diseases (SAD). These infections may also change the function of their immune system and/or cause problems with their blood vessels. Researchers want to learn how people with SAD respond to treatments or vaccines for COVID-19. The objective of this study is to understand how COVID-19 affects inflammation, the immune system, and blood vessels in adults and children with autoimmune diseases.
ClinicalTrials.gov Identifier: NCT00001372
Patients with Lupus have an increased risk of developing heart attacks and stroke due to hardening of the arteries (atherosclerosis). By examining how your blood vessels function and whether they are damaged and by comparing these tests to those of patients without Lupus, we will be able to better understand what triggers this complication in lupus and hopefully identify potential strategies to prevent this damage. During this study, it is possible that we will obtain an unanticipated finding about your health during the imaging studies. An example of an unanticipated finding would be a nodule, abnormality, or cancer in your colon, lungs, or other areas of your body seen on the imaging studies. We can provide you this information to take to your doctor if there is/are any findings on the scans. The procedures include Blood, urine, PET/CT scan, CT Heart scan, Cardiac MRI, Vascular procedures (EndoPat/CAVI/Sphygmocor testings). You will need to fast for most of the day for scans, water is ok to drink. Individual participation requires 2-3 visits to the NIH Clinical Center and 1 follow-up phone call to explaining the results of the scans.
ClinicalTrials.gov Identifier: NCT00001372
We are examining how blood vessels function and how these vessels damaged due to lupus disease activities. We compare the data to see what the blood vessels should be as healthy person such as you but due to the Lupus disease activities how it changed compare to a healthy volunteer on the same age and gender. During this study, it is possible that we will obtain an unanticipated finding about your health during the imaging studies. An example of an unanticipated finding would be a nodule, abnormality, or cancer in your colon, lungs, or other areas of your body seen on the imaging studies. We can provide you this information to take to your doctor if there is/are any findings on the scans. Thank you for your contribution as healthy volunteer to make a difference and better understand the Lupus Vascular Study. The procedures include Blood, urine, PET/CT scan, CT Heart scan, Cardiac MRI, Vascular procedures (EndoPat/CAVI/Sphygmocor testings). You will need to fast for most of the day for scans, water is ok to drink. Individual participation requires 2-3 visits to the NIH Clinical Center and 1 follow-up phone call to explaining the results of the scans.
ClinicalTrials.gov Identifier: NCT04233164
This is a study of the acute effects of glucocorticoids (also commonly called “steroids”) on the immune system of patients with SLE. Participants will receive a single intravenous (IV) infusion of methylprednisolone sodium succinate (steroid infusion). The main purpose of this study is to better understand how glucocorticoids (steroids) change the way the body reads genes. This information may be helpful for developing new and better drugs for treating SLE that have the same benefits as glucocorticoids (steroids) but without the side effects. Individual participation requires 2 visits to the NIH Clinical Center and 2 follow-up phone calls.
ClinicalTrials.gov Identifier: NCT00001372
This study follows a group of individuals over time who have SLE. The goals are:
- Most importantly to do various research studies to find out what causes SLE and gather clinical information relating to the natural history of the disease, comorbid conditions, and complications related to the disease treatment.
- To follow patients during the course of the disease to understand how the disease changes over time and the effects of standard treatments.
- To evaluate patients thought to have the disease to better understand how the disease begins and how it affects patients.
- To determine eligibility for specific research protocols involving patients with SLE requiring a separate informed consent.
- To obtain biologic specimens to be used in laboratory-based studies of the pathogenesis of SLE, including genetic studies and be used in laboratory-based studies of the pathogenesis of SLE from healthy volunteers.