Lupus Erythematosus, Systemic
Recent clinical, regulatory, research and industry developments relating to this disease.
CAR T-cell therapy for systemic lupus erythematosus: current status and future perspectives.
CAR-T-Cell Therapy for Systemic Lupus Erythematosus: A Comprehensive Overview.
Chimeric antigen receptor T cell therapy: a new emerging landscape in autoimmune rheumatic diseases.
Dawn of CAR-T cell therapy in autoimmune diseases.
Hormones and B-cell development in health and autoimmunity.
CD19 CAR T-Cell Therapy in Autoimmune Disease - A Case Series with Follow-up.
Th1-related transcription factors and cytokines in systemic lupus erythematosus.
Cytokines in Systemic Lupus Erythematosus-Focus on TNF-α and IL-17.
Immune podocytes in the immune microenvironment of lupus nephritis (Review).
What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
- 5 clinical trials expected to report results, the earliest in Q2 2027.
- Q2 2027A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multicenter Phase 3 Trial to Evaluate Efficacy, Safety and Tolerability of Ianalumab on Top of Standard-of-care Therapy in Participants With Active Lupus Nephritis (SIRIUS-LN).
- Q3 2027A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial and Open-Label Extension Study of Sirolimus in Patients With Systemic Lupus Erythematosus-Associated Immune Thrombocytopenia
- Q4 2028A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
- Q2 2029A Phase 3, Randomized, Double-Blind,Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants With Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care (ELOWEN-2)
- Q3 2029A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Safety and Tolerability of Cenerimod in Adult Patients With Systemic Lupus Erythematosus and Active Lupus Nephritis in Combination With Background Therapy
Clinical MilestonesView all 11Hide
- 2026-05-20A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Anifrolumab in Asian Participants With Active Systemic Lupus ErythematosusResults posted
- 2026-05-11A Multi-Center, Open-Label Study to Evaluate Safety, Efficacy and Pharmacokinetics of Belimumab Plus Standard Therapy in Chinese Paediatric Patients With Active Systemic Lupus Erythematosus (SLE)Results posted
- 2026-05-11A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients With ISN/RPS 2003 Class III or IV Lupus NephritisResults posted
- 2026-02-19A Two-cohort, Open-label, Single Arm, Multicenter Study to Evaluate Efficacy, Safety and Tolerability, PK and PD, of Emapalumab in Children and Adults With MAS in Still's Disease or With MAS in Systemic Lupus ErythematousResults posted
- 2026-07-02A Phase 3, Randomized, Double-Blind,Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants With Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care (ELOWEN-2)Results expected Q2 2029
- 2026-06-18A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial and Open-Label Extension Study of Sirolimus in Patients With Systemic Lupus Erythematosus-Associated Immune ThrombocytopeniaResults expected Q3 2027
- 2026-06-17A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Safety and Tolerability of Cenerimod in Adult Patients With Systemic Lupus Erythematosus and Active Lupus Nephritis in Combination With Background TherapyResults expected Q3 2029
- 2026-06-05A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus ErythematosusResults expected Q4 2028
- 2026-05-22A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multicenter Phase 3 Trial to Evaluate Efficacy, Safety and Tolerability of Ianalumab on Top of Standard-of-care Therapy in Participants With Active Lupus Nephritis (SIRIUS-LN).Results expected Q2 2027
- 2028-12-15A Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter, Multinational Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Active Lupus NephritisWithdrawn
- 2026-03-31A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Chinese Subjects With Active Systemic Lupus ErythematosusWithdrawn
- 2028-12-15ClinicalA Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter, Multinational Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Active Lupus NephritisWithdrawn
- 2026-07-02ClinicalA Phase 3, Randomized, Double-Blind,Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants With Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care (ELOWEN-2)Results expected Q2 2029
- 2026-06-18ClinicalA Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial and Open-Label Extension Study of Sirolimus in Patients With Systemic Lupus Erythematosus-Associated Immune ThrombocytopeniaResults expected Q3 2027
- 2026-06-17ClinicalA Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Safety and Tolerability of Cenerimod in Adult Patients With Systemic Lupus Erythematosus and Active Lupus Nephritis in Combination With Background TherapyResults expected Q3 2029
- 2026-06-05ClinicalA Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus ErythematosusResults expected Q4 2028
- 2026-05-22ClinicalA Randomized, Double-blind, Parallel Group, Placebo-controlled, Multicenter Phase 3 Trial to Evaluate Efficacy, Safety and Tolerability of Ianalumab on Top of Standard-of-care Therapy in Participants With Active Lupus Nephritis (SIRIUS-LN).Results expected Q2 2027
- 2026-05-20ClinicalA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Anifrolumab in Asian Participants With Active Systemic Lupus ErythematosusResults posted
- 2026-05-11ClinicalA Multi-Center, Open-Label Study to Evaluate Safety, Efficacy and Pharmacokinetics of Belimumab Plus Standard Therapy in Chinese Paediatric Patients With Active Systemic Lupus Erythematosus (SLE)Results posted
- 2026-05-11ClinicalA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients With ISN/RPS 2003 Class III or IV Lupus NephritisResults posted
- 2026-03-31ClinicalA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Chinese Subjects With Active Systemic Lupus ErythematosusWithdrawn
Therapeutic landscape
Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.
Approval — Saphnelo is indicated as an add-on therapy for the treatment of adult patients with moder… (2022)
Approval — Jayempi is indicated in combination with other immunosuppressive agents for the prophylax… (2021)
Approval — Benlysta is indicated as add-on therapy in patients aged 5 years and older with active, a… (2011)
Clinical trials
The current development programme across all trial phases.
Regulatory timeline
Drug regulatory events matched to this condition by indication — EMA.
European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.
Research activity
Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.
Major themes8
- Lupus Erythematosus, Systemic15
- Autoimmune Diseases5
- Immunotherapy, Adoptive4
- Receptors, Chimeric Antigen4
- Cytokines3
- T-Lymphocytes2
- Anti-Infective Agents1
- Antibodies, Monoclonal, Humanized1
Leading journals6
- Frontiers in immunology4
- International journal of molecular sciences3
- Annals of the rheumatic diseases1
- Arthritis & rheumatology (Hoboken, N.J.)1
- Biomolecules1
- Cellular & molecular immunology1
Leading researchers8
- Liu R2
- Vital EM2
- Abdalhadi HM1
- Abdul-Rahman T1
- Adebusoye FT1
- Aigner M1
- Al-Mossawi H1
- Alduraibi FK1
Affiliations (unnormalised)6
- "Grigore T. Popa" University of Medicine and Pharmacy1
- Affiliated Hospital of Southwest Medical University1
- and the Institute of Clinical Microbiology1
- Azienda Ospedaliero Universitaria Pisana1
- Basic Medical College1
- Brigham and Women's Hospital1
Disease biology
Key proteins & gene products studied in this disease. Number shows shared papers.
Related conditions
Diseases frequently studied alongside this one. Number shows shared papers.
Disease profile
A grounded synthesis of the condition — overview, causes, mechanism, risk factors and current standard of care.
Systemic lupus erythematosus is a chronic, relapsing, inflammatory, often febrile multisystem connective tissue disorder. It most commonly involves the skin, joints, kidneys, and serosal membranes, and is characterized by broad systemic dysfunction and the presence of LE cells in blood or bone marrow.
Its etiology is unknown. The supplied grounding describes it as an autoimmune disorder and suggests failure of normal immune regulatory mechanisms, with contributions from autoantibodies and immune dysregulation.
The disease is driven by autoimmune dysfunction with pathological autoantibody production and chronic inflammation leading to multi-organ damage. Literature grounding also points to cytokine imbalance, including TNF-α and IL-17, altered Th17/Treg balance, and neutrophil extracellular traps as contributors to inflammatory and tissue-destructive processes.
The supplied grounding does not support specific risk factors for systemic lupus erythematosus. It does indicate associations with vitamin D deficiency and hormonal deregulation in autoimmune disease broadly, but not as established risk factors specific to SLE.
Treatment is described at the class level as antimalarial drugs, glucocorticoids, immunosuppressants, and monoclonal antibodies. The grounding also notes chimeric antigen receptor T-cell therapy as an emerging investigational approach rather than established standard care.
AI-generated summary grounded in MeSH and 6 peer-reviewed sources. Informational only — not medical advice. Generated 2026-07-07.
Reference
Authoritative identity, definition & identifiers.
A chronic, relapsing, inflammatory, and often febrile multisystemic disorder of connective tissue, characterized principally by involvement of the skin, joints, kidneys, and serosal membranes. It is of unknown etiology, but is thought to represent a failure of the regulatory mechanisms of the autoimmune system. The disease is marked by a wide range of system dysfunctions, an elevated erythrocyte sedimentation rate, and the formation of LE cells in the blood or bone marrow.
- Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
- Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
- Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
- Related entities are derived from literature co-mention (studied together) — associative, not causal.