Overview

Research Areas (IRP Lab Groups)

The Lupus Clinical Trials Unit (LCTU) is a part of the National Institute of Arthritis and Musculoskeletal and Skin Disease (NIAMS). NIAMS is an institute of the National Institutes of Health (NIH) that is dedicated to clinical and translational research related to arthritis and musculoskeletal and skin disease.

The LCTU conducts innovative translational and clinical research into the causes, treatment, and prevention of systemic lupus erythematosus (SLE). We maintain 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 labs involved in lupus research. This collaborative research model has led to several biomarker discoveries and scientific hypotheses. These discoveries have been translated into clinical trials.

We develop and implement clinical research protocols and conduct high impact, innovative clinical research based largely on the discoveries resulting from NIAMS translational research.

Current Projects

  • 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

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 address 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 with an interdisciplinary team to implement a standardized template for outpatient visits incorporating osteoporosis assessment and management guidelines.
  • A specific sun protection brochure to educate patients 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 them in their healthcare process.
  • A disease indices tool monitors disease activity and damage accrual for every patient visit.

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 (elaine.poncio@nih.gov) or Isabel Ochoa (ochoai@mail.nih.gov) to be added to the mailing list.

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 (elaine.poncio@nih.gov) or Isabel Ochoa (ochoai@mail.nih.gov) to be added to the mailing list.

Clinical Trials

Recruiting
ClinicalTrials.gov Identifier: NCT05567198 

Systemic lupus erythematosus (SLE) is a disease that affects females nine times more often than males. People with SLE are often treated with cyclophosphamide (CYC). But CYC can damage a woman s ovaries; it may cause infertility. A drug called GnRHa is sometimes given to protect the ovaries during CYC therapy. But no one really knows how effective GnRHa treatment is. This natural history survey will compare women who received GnRHa during CYC therapy with those who did not.

Recruiting
ClinicalTrials.gov Identifier: NCT00024479

This study will explore the causes of rheumatic diseases and why many of them affect certain minority communities more severely.

Recruiting
ClinicalTrials.gov Identifier: NCT00001372

This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their relatives to learn more about how the disease develops and changes over time. It will also study genetic factors that make a person susceptible to SLE

Scientific Publications

Selected Recent Publications

Changes in cardiorespiratory function and fatigue following 12 weeks of exercise training in women with systemic lupus erythematosus: a pilot study.

Hasni S, Feng LR, Chapman M, Gupta S, Ahmad A, Munday A, Mazhar MA, Li X, Lu S, Tsai WL, Gadina M, Davis M, Chu J, Manna Z, Nakabo S, Kaplan MJ, Saligan L, Keyser R, Chan L, Chin LMK
Lupus Sci Med.
2022 Oct;
9(1).
doi: 10.1136/lupus-2022-000778
PMID: 36220328

Use of gonadotropin-releasing hormone agonists for ovarian preservation in patients receiving cyclophosphamide for systemic lupus erythematosus: A meta-analysis.

Ejaz K, Abid D, Juneau P, Chu J, Hasni S
Lupus.
2022 Dec;
31(14).
doi: 10.1177/09612033221128740
PMID: 36148853

Peroxisome proliferator activated receptor-γ agonist pioglitazone improves vascular and metabolic dysfunction in systemic lupus erythematosus.

Hasni S, Temesgen-Oyelakin Y, Davis M, Chu J, Poncio E, Naqi M, Gupta S, Wang X, Oliveira C, Claybaugh D, Dey A, Lu S, Carlucci P, Purmalek M, Manna ZG, Shi Y, Ochoa-Navas I, Chen J, Mukherjee A, Han KL, Cheung F, Koroleva G, Belkaid Y, Tsang JS, Apps R, Thomas DE, Heller T, Gadina M, Playford MP, Li X, Mehta NN, Kaplan MJ
Ann Rheum Dis.
2022 Aug 1;
81(11).
doi: 10.1136/ard-2022-222658
PMID: 35914929

Long-term follow-up after lymphodepleting autologous haematopoietic cell transplantation for treatment-resistant systemic lupus erythematosus.

Goklemez S, Hasni S, Hakim FT, Muraro PA, Pirsl F, Rose J, Memon S, Fowler DF, Steinberg SM, Baker EH, Panch SR, Gress R, Illei GG, Lipsky PE, Pavletic SZ
Rheumatology (Oxford).
2022 Aug 3;
61(8).
doi: 10.1093/rheumatology/keab877
PMID: 34875023

Clinical Images: Cardiovascular magnetic resonance to detect and monitor inflammatory myocarditis in systemic lupus erythematosus.

Pamuk ON, Bandettini WP, Vargha J, Shanbhag SM, Hasni S
ACR Open Rheumatol.
2022 Feb;
4(2).
doi: 10.1002/acr2.11364
PMID: 34791837

Risk Factors for COVID-19 and Rheumatic Disease Flare in a US Cohort of Latino Patients.

Fike A, Hartman J, Redmond C, Williams SG, Ruiz-Perdomo Y, Chu J, Hasni S, Ward MM, Katz JD, Gourh P
Arthritis Rheumatol.
2021 Jul;
73(7).
doi: 10.1002/art.41656
PMID: 33455077

European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) SLE classification criteria item performance.

Aringer M, Brinks R, Dörner T, Daikh D, Mosca M, Ramsey-Goldman R, Smolen JS, Wofsy D, Boumpas DT, Kamen DL, Jayne D, Cervera R, Costedoat-Chalumeau N, Diamond B, Gladman DD, Hahn B, Hiepe F, Jacobsen S, Khanna D, Lerstrøm K, Massarotti E, McCune J, Ruiz-Irastorza G, Sanchez-Guerrero J, Schneider M, Urowitz M, Bertsias G, Hoyer BF, Leuchten N, Schmajuk G, Tani C, Tedeschi SK, Touma Z, Anic B, Assan F, Chan TM, Clarke AE, Crow MK, Czirják L, Doria A, Graninger W, Halda-Kiss B, Hasni S, Izmirly PM, Jung M, Kumánovics G, Mariette X, Padjen I, Pego-Reigosa JM, Romero-Diaz J, Rúa-Figueroa Í, Seror R, Stummvoll GH, Tanaka Y, Tektonidou MG, Vasconcelos C, Vital EM, Wallace DJ, Yavuz S, Meroni PL, Fritzler MJ, Naden R, Costenbader K, Johnson SR
Ann Rheum Dis.
2021 Jun;
80(6).
doi: 10.1136/annrheumdis-2020-219373
PMID: 33568386

Bite of the wolf: innate immune responses propagate autoimmunity in lupus.

Gupta S, Kaplan MJ
J Clin Invest.
2021 Feb 1;
131(3).
pii: 144918. doi: 10.1172/JCI144918
PMID: 33529160

LOX-1: A potential driver of cardiovascular risk in SLE patients.

Sagar D, Gaddipati R, Ongstad EL, Bhagroo N, An LL, Wang J, Belkhodja M, Rahman S, Manna Z, Davis MA, Hasni S, Siegel R, Sanjuan M, Grimsby J, Kolbeck R, Karathanasis S, Sims GP, Gupta R
PLoS One.
2020;
15(3).
doi: 10.1371/journal.pone.0229184
PMID: 32182251

Using the circulating proteome to assess type I interferon activity in systemic lupus erythematosus.

Smith MA, Chiang CC, Zerrouki K, Rahman S, White WI, Streicher K, Rees WA, Schiffenbauer A, Rider LG, Miller FW, Manna Z, Hasni S, Kaplan MJ, Siegel R, Sinibaldi D, Sanjuan MA, Casey KA
Sci Rep.
2020 Mar 10;
10(1).
doi: 10.1038/s41598-020-60563-9
PMID: 32157125

Transcriptomic, epigenetic, and functional analyses implicate neutrophil diversity in the pathogenesis of systemic lupus erythematosus.

Mistry P, Nakabo S, O'Neil L, Goel RR, Jiang K, Carmona-Rivera C, Gupta S, Chan DW, Carlucci PM, Wang X, Naz F, Manna Z, Dey A, Mehta NN, Hasni S, Dell'Orso S, Gutierrez-Cruz G, Sun HW, Kaplan MJ
Proc Natl Acad Sci U S A.
2019 Dec 10;
116(50).
doi: 10.1073/pnas.1908576116
PMID: 31754025

Key Publications

Long-term follow-up after lymphodepleting autologous hematopoietic cell transplantation for treatment-resistant systemic lupus erythematosus.

Goklemez S, Hasni S, Hakim FT, Muraro PA, Pirsl F, Rose J, Memon S, Fowler DF, Steinberg SM, Baker EH, Panch SR, Gress R, Illei GG, Lipsky PE, Pavletic SZ
Rheumatology (Oxford).
2021 Dec 7;
pii: keab877. doi: 10.1093/rheumatology/keab877
PMID: 34875023

Risk Factors for COVID-19 and Rheumatic Disease Flare in a US Cohort of Latino Patients.

Fike A, Hartman J, Redmond C, Williams SG, Ruiz-Perdomo Y, Chu J, Hasni S, Ward MM, Katz JD, Gourh P
Arthritis Rheumatol.
2021 Jul;
73(7).
doi: 10.1002/art.41656
PMID: 33455077

Phase 1 double-blind randomized safety trial of the Janus kinase inhibitor tofacitinib in systemic lupus erythematosus.

Hasni SA, Gupta S, Davis M, Poncio E, Temesgen-Oyelakin Y, Carlucci PM, Wang X, Naqi M, Playford MP, Goel RR, Li X, Biehl AJ, Ochoa-Navas I, Manna Z, Shi Y, Thomas D, Chen J, Biancotto A, Apps R, Cheung F, Kotliarov Y, Babyak AL, Zhou H, Shi R, Stagliano K, Tsai WL, Vian L, Gazaniga N, Giudice V, Lu S, Brooks SR, MacKay M, Gregersen P, Mehta NN, Remaley AT, Diamond B, O'Shea JJ, Gadina M, Kaplan MJ
Nat Commun.
2021 Jun 7;
12(1).
doi: 10.1038/s41467-021-23361-z
PMID: 34099646

Lupus-like autoimmunity and increased interferon response in patients with STAT3-deficient hyper-IgE syndrome.

Goel RR, Nakabo S, Dizon BLP, Urban A, Waldman M, Howard L, Darnell D, Buhaya M, Carmona-Rivera C, Hasni S, Kaplan MJ, Freeman AF, Gupta S
J Allergy Clin Immunol.
2021 Feb;
147(2).
doi: 10.1016/j.jaci.2020.07.024
PMID: 32768442

Sex differences in neutrophil biology modulate response to type I interferons and immunometabolism.

Gupta S, Nakabo S, Blanco LP, O'Neil LJ, Wigerblad G, Goel RR, Mistry P, Jiang K, Carmona-Rivera C, Chan DW, Wang X, Pedersen HL, Gadkari M, Howe KN, Naz F, Dell'Orso S, Hasni SA, Dempsey C, Buscetta A, Frischmeyer-Guerrerio PA, Kruszka P, Muenke M, Franco LM, Sun HW, Kaplan MJ
Proc Natl Acad Sci U S A.
2020 Jul 14;
117(28).
doi: 10.1073/pnas.2003603117
PMID: 32601182

LOX-1: A potential driver of cardiovascular risk in SLE patients.

Sagar D, Gaddipati R, Ongstad EL, Bhagroo N, An LL, Wang J, Belkhodja M, Rahman S, Manna Z, Davis MA, Hasni S, Siegel R, Sanjuan M, Grimsby J, Kolbeck R, Karathanasis S, Sims GP, Gupta R
PLoS One.
2020;
15(3).
doi: 10.1371/journal.pone.0229184
PMID: 32182251

2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus.

Aringer M, Costenbader K, Daikh D, Brinks R, Mosca M, Ramsey-Goldman R, Smolen JS, Wofsy D, Boumpas DT, Kamen DL, Jayne D, Cervera R, Costedoat-Chalumeau N, Diamond B, Gladman DD, Hahn B, Hiepe F, Jacobsen S, Khanna D, Lerstrøm K, Massarotti E, McCune J, Ruiz-Irastorza G, Sanchez-Guerrero J, Schneider M, Urowitz M, Bertsias G, Hoyer BF, Leuchten N, Tani C, Tedeschi SK, Touma Z, Schmajuk G, Anic B, Assan F, Chan TM, Clarke AE, Crow MK, Czirják L, Doria A, Graninger W, Halda-Kiss B, Hasni S, Izmirly PM, Jung M, Kumánovics G, Mariette X, Padjen I, Pego-Reigosa JM, Romero-Diaz J, Rúa-Figueroa Fernández Í, Seror R, Stummvoll GH, Tanaka Y, Tektonidou MG, Vasconcelos C, Vital EM, Wallace DJ, Yavuz S, Meroni PL, Fritzler MJ, Naden R, Dörner T, Johnson SR
Arthritis Rheumatol.
2019 Sep;
71(9).
doi: 10.1002/art.40930
PMID: 31385462

Safety and Tolerability of Omalizumab: A Randomized Clinical Trial of Humanized Anti-IgE Monoclonal Antibody in Systemic Lupus Erythematosus.

Hasni S, Gupta S, Davis M, Poncio E, Temesgen-Oyelakin Y, Joyal E, Fike A, Manna Z, Auh S, Shi Y, Chan D, Carlucci P, Biehl A, Dema B, Charles N, Balow JE, Waldman M, Siegel RM, Kaplan MJ, Rivera J
Arthritis Rheumatol.
2019 Jul;
71(7).
doi: 10.1002/art.40828
PMID: 30597768

Distinct Functions of Autoantibodies Against Interferon in Systemic Lupus Erythematosus: A Comprehensive Analysis of Anticytokine Autoantibodies in Common Rheumatic Diseases.

Gupta S, Tatouli IP, Rosen LB, Hasni S, Alevizos I, Manna ZG, Rivera J, Jiang C, Siegel RM, Holland SM, Moutsopoulos HM, Browne SK
Arthritis Rheumatol.
2016 Jul;
68(7).
doi: 10.1002/art.39607
PMID: 26815287

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Dr. Sarfaraz Hasni Receives 2021 Coleman Research Innovation Award

We are delighted to announce that Sarfaraz Hasni, M.D., Director of the NIAMS Lupus Clinical Trials Unit, has received the 2021 William G. Coleman Jr., Ph.D., Minority Health and Health Disparities Research Innovation Award.