Lupus is a chronic autoimmune disease that produces multisystemic inflammation and abnormal immune responses, wreaking havoc on multiple organs.
Around 1% of NLE affects the skin, liver, and blood, and is detected in infants. It is triggered by maternal autoantibodies that penetrate the placenta. NLE responds to the therapy in between 3 and 4 months.
People between the ages of 30 and 40 years are affected by DLE. Chronic scarring and atrophic photosensitive dermatosis are two DLE symptoms that are susceptible to SLE.
DIL is established as a result of drug exposure that sets off an immunological response. Widely referred to as lupus, DIL is typically diagnosed in 20–150 people per 100,000 and affects women who are of reproductive maturity.
The SLE is most common and most serious type of lupus. SLE dominates among the populations across Native Americans, Asians, African Americans, and Hispanics. Also, 15–30% of SLE patients with an early diagnosis have Lupus Nephritis (LN) and 30–50% develop LN as the disease progresses. Due to the genetic predisposition, abnormalities in the lymphocytes and autoantibody production significantly increase kidney failure. Furthermore, Lupus hepatitis (LH) is commonly associated with SLE and is usually asymptomatic. Lupus hepatitis reported in patients diagnosed with SLE is nearly about 3-23%.
Lupus disease associated with immune system dysfunction involves autoantibodies that target healthy immune cells & somatic cells. Autoantibodies are antinuclear antibodies (ANA) that target the nucleus of cells. These antibodies bind to self-antigen, such as DNA or proteins, forming immune complexes that circulate in the bloodstream and deposit in various tissues. This process triggers inflammation & tissue damage. The activated immune cells & immune complexes release pro-inflammatory cytokines, including tumour necrosis factor-alpha (TNF-Alpha) & interleukin, leading to further inflammation & immune cell recruitment. Additionally, individuals with lupus often experience increased production of type I interferons, which regulate immune responses.
Lupus has poor clearance of apoptotic cells, which leads to their buildup and subsequent immunological response and autoantibody formation. Lupus is caused by hereditary factors, and specific genetic abnormalities have been linked to an increased risk of developing the illness. Though the specific etiology of Lupus Erythematosus is unknown, it is thought to include a complex combination of genetic, environmental, and hormonal variables.
The Lupus Foundation of America estimates that the condition affects ~ 5 million individuals globally and 1.5 million in the United States. Additionally, 90% of lupus patients between the ages of 15 and 44 years are female. Furthermore, 10 to 15% of individuals die from complications from early lupus.
The incidence and prevalence rate for lupus disease varies in every country. For instance, in the United States, DLI estimates that the rate of Systemic Lupus Erythematosus (SLE) is 54 per 100,000 persons. Whereas, Ukraine and Africa have the lowest incidence and prevalence rates of lupus disease.
Lupus affects multiple organs and tissues in the body. Though the exact cause of lupus is not known, it is believed to involve a complex interplay of genetic, environmental & hormonal factors associated with the cause of Lupus Erythematosus. The exact pathogenesis is not yet known since several findings are reported.
Systemic lupus erythematosus (SLE) is unable to diagnose easily since each type of Lupus has similar signs, symptoms & conditions. The SLE diagnosis is difficult because symptoms vary greatly from person to person and change over time. Early symptoms are undetectable & further converted into severe symptoms. Delay in the diagnosis further leads towards the chronic stage of disease, hence the early diagnosis is required.
The common tests used to diagnose lupus disease are -
Erythrocytes from the blood sample are examined for their rate of sedimentation to diagnose lupus.
Erythrocyte sedimentation rate is an indirect indicator of inflammation. The test measures the red blood cell (Erythrocyte) settlement rate in the test tube of the blood. As cells can stick together & settle more quickly than individual cells, inflammation is a positive Lupus disease.
ANA, or immune system-attacking antibodies, examined as 0–4 in lupus disease, are produced by the body. Higher titers suggest a greater chance of autoimmune illness. Lupus frequently has positive ANA results, although this is not a diagnosis. About 10% of those without autoimmune diseases could have weaker, positive ANA. The ANA test has a 98% specificity and 97% sensitivity for the diagnosis of SLE. An anti-DNA test, also known as an Anti-DNA antibody test, identifies different types of antibodies in our blood. The majority of those who take this test are found to have SLE in about 70% of cases.
A piece of tissue is extracted with a needle or by a small incision and examined under a microscope. The tissue exhibits a variety of autoimmune disease symptoms. A liver biopsy is used to diagnose lupus hepatitis.
Diagnostic Techniques Market Player |
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Imaging Devices |
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Chest X-ray |
Computerized CT |
Seimens Healthiners |
Sanying Precision Instruments Co., Ltd |
GE Healthcare |
WENZEL Metrology GmbH |
Philips Healthcare |
Royma Tech (Suzhou) Precision Co., Ltd |
Fujifilm Medical System |
ZEISS Industrial Metrology |
Canon Medical System |
Bruker AXS GmbH |
Hitachi Medical System |
Waygate Technologies |
Shimadzu Corporation |
Comet Yxlon GmbH |
Diagnostic Product |
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Imaging Devices |
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Chest X-ray |
Computerized CT |
MOBILETT Elara Max |
Phoenix V|tome|x M300 |
Definium™ 646 HD X-ray system |
SKYSCAN 2214 |
Radiography 7000 C — DigitalDiagnost C90 |
ZEISS METROTOM 6 scout (GOM CT) |
FDR Smart f |
CT computed tomography system FF20 CT |
Zexira i9 |
CT computed tomography system nanoVoxel-1000 |
Supria |
CT computed tomography machine exaCT U series |
Digital Radiographic Mobile X-ray System - MobileDaRt Evolution MX8 Version |
CT computed tomography machine RMCT1000 |
Lupus disease, which can be remedied, weakens the immune system and dermal systems. Anti-inflammatory medications, antimalarial medications, corticosteroids, and immunosuppressants are instances of NSAIDs. As a result, multiple treatments are employed which can benefit both the treatment industry and the patients.
The non-steroidal anti-inflammatory drugs, comprising Naproxen sodium (Aleve) & Ibuprofen (Advil, Motrin IB), are given over the counter and are used to treat pain, swelling, and fever caused due to Lupus disease.
The antimalarial drugs are also capable to treat Lupus disease. Antimalarial drugs like hydroxychloroquine (Plaquenil) & chloroquine phosphate (Aralen) minimize lupus infection by showing effect on patient’s immune system.
Lupus is treated with Prednisolone analogs, mainly methylprednisolone (Medrol). Internal inflammation in such conditions is reduced by these medications.
These medications reduce the amount of aberrant B cells (immune system cells that produce antibodies) present in people with lupus. Belimumab, a typical form of BLyS-specific inhibitor used to treat lupus symptoms, inhibits the function of a particular protein in the body that is involved in the immune response. Infusions of monoclonal antibodies are offered to treat Lupus.
For the treatment of Lupus, biologicals such as Belimumab and Rituximab are injected intravenously. Belimumab (Benlysta®) was authorized in 2019 for paediatric SLE and in 2020 for Lupus Nephritis. Voclosporin (LupkynisTM) is an FDA-approved lupus therapy.
Immunosuppressive medications like Azathioprine, Mycophenolate, Methotrexate, & Lefluniamide can encourage the immune system, which reduces the severity of sickness.
Therapy |
Mode of Action |
Typical Dosing |
Formulation |
Side Effects |
NSAIDS (Including salicylates) |
Blocks PG synthesis by inhibiting the COX-I enzyme |
Various dosages & various agents |
Oral dosage Tablets |
Gastrointestinal irritation & bleeding, renal toxicity, hepatic toxicity |
Corticosteroid (Prednisolone) |
Inhibition of cytokine activation & inhibiting Interleukin & by TNF-α inhibiting |
0.5–1 mg/kg prednisone equivalent with or without initial pulse intravenous (IV) methylprednisolone |
IV, Topical Glucocorticoids analogue |
Weight gain, hypertension, hyperglycemia, hyperlipidemia, osteoporosis, cataracts, edema, hypokalemia, muscle weakness, growth suppression, increased risk of infection, glaucoma |
Antimalarials (Hydroxychloroquine) |
Interfere with T-cell Activation & inhibit cytokine activity |
Hydroxychloroquine oral 200-400 mg/daily |
Tablet; Oral route |
Muscular damage, muscle weakness |
Immunosuppressants (Azathioprine) |
Reduction of T-cell & B-cells proliferation. DNA & RNA disruptions |
Azathioprine Oral 1-3mg/kg per day |
Tablet; Oral route |
Renal dysfunction, myelosuppression, infertility, risk of cancer |
Monoclonal Antibodies (Belimumab) |
BLyS-specific inhibitor i.e., acts on B lymphocyte stimulator |
Belimumab IV 10mg/kg (Over a period of 1hr), every 2 weeks for the first three doses, then every 4 weeks |
I.V. Infusion, or Subcutaneous Injection. |
Nausea, diarrhea, pyrexia, nasopharyngitis, insomnia |
Treatment Market Players |
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Topical Therapy |
Orally Active Therapy |
Biological Products |
Ajanta Pharma Ltd |
Pfizer Ltd |
Pfizer Ltd |
Abbott pharmaceuticals |
Panacea Biotech Ltd |
Neiss Labs Pvt Ltd |
Macleod’s Pharmaceuticals Pvt Ltd |
RPG Life Sciences Ltd |
Kabir Life Sciences |
Intas Pharmaceuticals Ltd |
Cipla Ltd |
Beulah Bio Medics Ltd |
Ipca Laboratories Ltd |
Roche Products India Pvt Ltd |
BMW Pharmaco India Pvt. Ltd |
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Ipca Laboratories Ltd |
Asterisk Laboratories India Pvt Ltd |
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Wallace Pharmaceuticals Pvt Ltd |
Syndicate Life Sciences Pvt Ltd |
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Novartis India Ltd |
Ipca Laboratories Ltd |
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Cian Health Care Pvt Ltd |
Novartis India Ltd |
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Horizion therapeutics |
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Biogen |
Treatment products |
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Topical Therapy |
Orally Active Therapy |
Immunological Therapy |
Softcor MP Cream |
Medrol 8mg Tablet |
Solu-Medrol 1gm Injection |
MPA CREAM |
Imuza Tablet |
Nispred 500mg Injection |
Omnacortil 0.1% Cream |
Azoran Tablet |
Merilone 40mg Injection |
Apderm Cream |
Thiazprine 50mg Tablet |
Biopred 1000mg Injection |
Trexjoy Gel |
Innomune Tablet |
Nayapred 40mg Injection |
Folitrax LP Gel |
Cellcept 500mg Tablet |
MRD-S Injection |
Rextop 1% Gel |
Mycept 250 Capsule |
Wellpred 40 Injection |
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Mycept Suspension |
Folitrax 20 Injection |
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Folitrax 20 Tablet |
Sandimmun Injection |
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Mext 15 Tablet |
Antima 100mg Syrup |
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Sandimmun Neoral 50mg Soft Gelatin Capsule |
Benlysta® |
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HCQS 200 Tablet |
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Ciaclor 200mg Tablet |
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Lupkynis™ |
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Lupkynis interacts with the calcineurin protein, which activates T-cells within the immune system. This activation helps to decrease inflammation in the kidney. Further, it stimulates an autoimmune response in the immune system. Lupkynis (Voclosporin) was approved by the U.S. Food & Drug Administration (FDA) for the treatment of Lupus Nephritis in January 2021. Aurinia Pharmaceuticals, Inc based in Vancouver, British Columbia, Canada, developed Lupkynis as a treatment for LN.
New medicines that target entirely novel immune cells for treatment are currently being developed. The Plasmacytoid Dendritic Cells (pDCs) can drive Cutaneous Lupus Erythematous (CLE) pathogenesis. Majorly, these cells are found in CLE tissue after sun exposure & secrete proinflammatory cytokinins & chemokines which drive the severity of the disease.
Two potential therapies, Litifilimab & Daxilimab are currently in exploratory & preclinical phases of clinical trials, respectively. These molecules are being investigated by Biogen & Horizion Therapeutics for the clinical efficacy response & reduction of the severity of lupus symptoms.
In the future, a potential treatment for lupus may include targeted antibodies against specific proteins in the immune system. Litiflimab, an antibody against BDCA2, could disrupt interferon production, which links to the lupus disease activity. Another antibody, Dapirolizumab pegol, blocks CD40L, a protein in B & T cells that regulates the immune system and declines the severity of lupus disease.
Additionally, the Telitacicept activates the B cell activating factor inhibitor and an immunomodulator. The Telitacicept treatment, developed by RemeaGen & RC Pharma, shows potential in modulating the immune system in lupus disease.
As such, the successful commercialization of Litiflimab, Daxilimab, Dapirolizumab pegol, & Telitacicept could result in substantial revenue growth for the companies, while also providing a much-needed solution for lupus patients.
Phase 1 |
Phase 2 |
Phase 3 |
Phase 4 |
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Lupus |
A Phase Ib Study of Nivolumab in Patients with Autoimmune Disorders and Advanced Malignancies (AIM-NIVO) |
A Multicentre Randomized Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients with Active Proliferative Lupus Nephritis |
Pilot Trial of Belimumab in Early Lupus |
Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus (ALE11) |
A Phase 1b/2, Double-Blind, Placebo-Controlled, Randomized, Parallel-Arm Study to Explore the Safety, Pharmacokinetics, and Proof of Biological Activity of DS-7011a in Patients with Systemic Lupus Erythematosus and Active Cutaneous Lupus Erythematosus |
A 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) |
Minimizing Glucocorticoid Administration in Patients with Proliferative Lupus Nephritis During the Induction of Remission Period-EUROLUPUS vs. RITUXILUP Regimen: A Randomized Study |
An Open-label, Multi-center, Phase 1/2 Study to Assess the Safety, Efficacy, and Cellular Kinetics of YTB323 in Participants with Severe, Refractory Systemic Lupus Erythematosus |
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescent Patients with Active Class III or IV Lupus Nephritis |
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants with Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care
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Open-label Prospective Randomized Study to Determine the Efficacy and Safety of Two Dosing Regimens of ACTHar in the Treatment of Proliferative Lupus Nephritis |
A Single-Arm, Phase 1b, Open-Label Study to Assess the Safety, Tolerability, and Pharmacodynamics of Repeat-Doses of Subcutaneous ANX009 With Standard of Care Therapy in Adult Participants with Lupus Nephritis |
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Investigate the Efficacy and Safety of Daxdilimab Subcutaneous Injection in Reducing Disease Activity in Adult Participants with Moderate-to-Severe Primary Discoid Lupus Erythematosus |
Induction Therapy for Lupus Nephritis With no Added Oral Steroids: An Open-Label Randomised Multicentre Controlled Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF |
A Randomized Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus and Corticosteroids in Comparison with Mycophenolate Mofetil and Corticosteroids in Subjects with Class III/IV±V Lupus Nephritis |
The discovery of these innovative medicines provides substantial financial potential for the pharmaceutical sector. If successful, these treatments have the potential to address a substantial unmet medical need in the lupus therapeutics market portfolio.
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