Cutaneous lupus erythematosus

SAPHNELO (anifrolumab) Approved in the US for Moderate to Severe Systemic Lupus Erythematosus

Retrieved on: 
Monday, August 2, 2021
FDA, Health, Clinical trials, General Health, Pharmaceutical, Biotechnology, Medical specialties, Autoimmune diseases, Clinical medicine, Medicine, Cutaneous lupus erythematosus, Connective tissue diseases, Lupus, William Osler, Syndromes, Anifrolumab, Sjögren syndrome, Rheumatology

AstraZenecas SAPHNELO (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.

Key Points: 
  • AstraZenecas SAPHNELO (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.
  • SAPHNELO is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy.
  • Limitations of Use: The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus.
  • The Companys growing presence in immunology is focused on five mid- to late-stage franchises with multi-disease potential, in areas including rheumatology (including systemic lupus erythematosus), dermatology, gastroenterology, and systemic eosinophilic-driven diseases.

Lupus Foundation of America Celebrates FDA Approval of Saphnelo™ (Anifrolumab-fnia) as a New Treatment for Lupus

Retrieved on: 
Monday, August 2, 2021
Medical specialties, Medicine, Clinical medicine, Autoimmune diseases, Cutaneous lupus erythematosus, Connective tissue diseases, Lupus, William Osler, Autoimmune disease, Sjögren syndrome, Lupus erythematosus

It is the third U.S. FDA approval of a lupus therapy since 2011, expanding treatment options for this medically underserved and life-threatening autoimmune disease.

Key Points: 
  • It is the third U.S. FDA approval of a lupus therapy since 2011, expanding treatment options for this medically underserved and life-threatening autoimmune disease.
  • With the approval of Saphnelo, we now have one more drug that allows us to translate valuable research knowledge into clinical practice with multiple benefits for our patients with lupus."
  • Saphnelo showed benefits on overall lupus disease activity, skin lupus and joints and the ability to taper down steroid doses.
  • The Lupus Foundation of America's research during the 1980s contributed to the development of Saphnelo through its support of research on interferons.

Lupus Research Alliance Applauds U.S. FDA Approval of AstraZeneca's anifrolumab-fnia (Saphnelo™) for Systemic Lupus Erythematosus (SLE)

Retrieved on: 
Monday, August 2, 2021
Medical specialties, Cutaneous lupus erythematosus, Medicine, Clinical medicine, Autoimmune diseases, Lupus, William Osler, Draft:Lupus UK, Lupus Foundation of America

Given by intravenous infusion, anifrolumab-fnia works by blocking immune system molecules called type I interferons that are one of the main factors that leads to tissue damage and disease symptoms. Type I interferons are a family of 17 similar molecules that help protect us from infections.i Research has shown that the vast majority -- 60-80 percent of adultsii -- have high levels of type I interferons.

Key Points: 
  • The approval represents the first new treatment for generalized SLE in more than a decade and is the result of significant seminal research funded originally by the Lupus Research Alliance.
  • One of the trailblazers in interferon research is former chair of the Lupus Research Alliance Scientific Advisory Board Dr. Mary Crow.
  • Over the past two decades, the Lupus Research Alliance has made significant investments in research focused on the role of type I interferons in lupus.
  • Because the Lupus Research Alliance's Board of Directors fund all administrative and fundraising costs, 100% of all donations goes to support lupus research programs.

Lupus Research Alliance Applauds U.S. FDA Approval of AstraZeneca's anifrolumab-fnia (Saphnelo™) for Systemic Lupus Erythematosus (SLE)

Retrieved on: 
Monday, August 2, 2021
Medical specialties, Cutaneous lupus erythematosus, Medicine, Clinical medicine, Autoimmune diseases, Lupus, William Osler, Draft:Lupus UK, Lupus Foundation of America

Given by intravenous infusion, anifrolumab-fnia works by blocking immune system molecules called type I interferons that are one of the main factors that leads to tissue damage and disease symptoms. Type I interferons are a family of 17 similar molecules that help protect us from infections.i Research has shown that the vast majority -- 60-80 percent of adultsii -- have high levels of type I interferons.

Key Points: 
  • The approval represents the first new treatment for generalized SLE in more than a decade and is the result of significant seminal research funded originally by the Lupus Research Alliance.
  • One of the trailblazers in interferon research is former chair of the Lupus Research Alliance Scientific Advisory Board Dr. Mary Crow.
  • Over the past two decades, the Lupus Research Alliance has made significant investments in research focused on the role of type I interferons in lupus.
  • Because the Lupus Research Alliance's Board of Directors fund all administrative and fundraising costs, 100% of all donations goes to support lupus research programs.

Lupus Foundation of America Provides Six Grants to Young Scientists Supporting Important Lupus Research

Retrieved on: 
Thursday, July 22, 2021
Medical specialties, Medicine, Clinical medicine, Cutaneous lupus erythematosus, Lupus, William Osler, Lupus Canada

The fellowship program provides grant and mentorship support for young scientists and plays an important role in establishing the next generation of lupus researchers and the future of the lupus research field.

Key Points: 
  • The fellowship program provides grant and mentorship support for young scientists and plays an important role in establishing the next generation of lupus researchers and the future of the lupus research field.
  • Each 2021 Finzi awardee is mentored throughout their research project by an experienced lupus investigator, a critical component ensuring that the young scientists receive support and guidance as they establish themselves in lupus research.
  • The Gina M. Finzi Memorial Student Summer Fellowship Program has supported the work of nearly 200 young scientists in North America.
  • Past recipients from the program have gone on to lead innovative and groundbreaking lupus research and have become distinguished lupus scientists in the field.

AVISE® Lupus Test Demonstrates Statistically Significant Clinical Utility in Achieving a Definitive SLE Diagnosis and Positively Impacts Treatment Decisions

Retrieved on: 
Tuesday, July 13, 2021
Autoimmune diseases, Medical specialties, Clinical medicine, Cutaneous lupus erythematosus, Medicine, Lupus, William Osler, Connective tissue diseases, Anti-SSA/Ro autoantibodies

This multi-center study demonstrated that the AVISE Lupus test helped increase confidence in ruling-in and ruling-out systemic lupus erythematosus (SLE) in patients suspected of this disease and informed appropriate treatment decisions.

Key Points: 
  • This multi-center study demonstrated that the AVISE Lupus test helped increase confidence in ruling-in and ruling-out systemic lupus erythematosus (SLE) in patients suspected of this disease and informed appropriate treatment decisions.
  • Assessment of the confidence in the diagnosis of SLE and initiation of hydroxychloroquine (HCQ) showed that the AVISE Lupus test impacted physician behavior.
  • In particular, physician certainty in an SLE diagnosis increased with increasing AVISE Lupus scores.
  • Similarly, certainty in an SLE diagnosis decreased when an AVISE Lupus score was negative, indicating that the test helped in both ruling-in and in ruling-out the disease.

Equillium Announces Plans to Initiate Phase 3 Pivotal Study of Itolizumab in First-line Treatment of Acute Graft-Versus-Host Disease Following End-of-Phase 1 Meeting with the FDA

Retrieved on: 
Monday, July 12, 2021
Medical specialties, Clinical medicine, Medicine, Kidney diseases, Cutaneous lupus erythematosus, Lupus, William Osler, Graft-versus-host disease, Nephritis

The meeting confirmed a path to advance itolizumab into a single Phase 3 pivotal study to support the Biologics License Application (BLA) filing for itolizumab in first-line treatment of aGVHD patients.

Key Points: 
  • The meeting confirmed a path to advance itolizumab into a single Phase 3 pivotal study to support the Biologics License Application (BLA) filing for itolizumab in first-line treatment of aGVHD patients.
  • The company plans to initiate the Phase 3 study in Q4 2021.
  • Equillium is finalizing details of the Phase 3 protocol based on feedback and guidance from the FDA.
  • Equillium is developing itolizumab for multiple severe immuno-inflammatory diseases, including a planned pivotal study in acute graft-versus-host-disease (aGVHD), a Phase 1b study in lupus/lupus nephritis and a Phase 1b study in uncontrolled asthma.

Aurinia Awards $250,000 in Grants to Support Patient Navigation Programs

Retrieved on: 
Wednesday, June 30, 2021
Health, Other Science, Research, Pharmaceutical, Science, Biotechnology, Cutaneous lupus erythematosus, Lupus, William Osler, Aurinia, Medical specialties, Medicine, Clinical medicine, systemic lupus erythematosus (SLE) and lupus nephritis (LN), Aurinia, SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) AND LUPUS NEPHRITIS (LN), AURINIA

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the Company) today announced the recipients of five $50,000 grant awards to support implementation patient navigation programs targeted toward disadvantaged populations at most risk of developing SLE and LN.

Key Points: 
  • Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the Company) today announced the recipients of five $50,000 grant awards to support implementation patient navigation programs targeted toward disadvantaged populations at most risk of developing SLE and LN.
  • The five recipients were awarded grants based on their demonstrated ability to collaborate with key lupus centers, rheumatologists, and nephrologists, their ability to measure program outcomes, and ultimately, provide individualized support to underserved populations.
  • Navigation programs will be launched in the following cities:
    The need for a patient navigator program at our institution, and many like ours, is enormous.
  • Aurinia funded patient navigator programs launch on July 1 and grant recipients will convene regularly to share lessons learned, best practices, and community needs that can be addressed through navigation services throughout the 1-year grant period.

Horizon Therapeutics plc Announces First Patient Enrolled in Phase 2 Trial Evaluating HZN-7734 for the Treatment of Systemic Lupus Erythematosus

Retrieved on: 
Tuesday, June 29, 2021
Health, Clinical trials, Research, Pharmaceutical, Science, Biotechnology, Medical specialties, Cutaneous lupus erythematosus, Autoimmune diseases, Branches of biology, Medicine, Lupus, Plasmacytoid dendritic cell, Dendritic cell, Anifrolumab, Acute cutaneous lupus erythematosus, HZN-7734, Systemic Lupus Erythematosus (SLE), Horizon, HZN-7734, SYSTEMIC LUPUS ERYTHEMATOSUS (SLE), HORIZON

HZN-7734 also improved Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity ( CLASI-A ) scores, a clinical measure of cutaneous lupus, versus placebo.

Key Points: 
  • HZN-7734 also improved Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity ( CLASI-A ) scores, a clinical measure of cutaneous lupus, versus placebo.
  • The composite primary endpoint of the Phase 2 trial is change in the British Isles Lupus Assessment Group (BILAG)-based Combined Lupus Assessment (BICLA) and reduction in oral glucocorticoid dose after 48 weeks.
  • Additional trial endpoints include other measures of both lupus disease activity and oral glucocorticoid reduction.
  • Depleting plasmacytoid dendritic cells reduces local type I interferon responses and disease activity in subjects with cutaneous lupus.

SLE-UPDATE Study Finds Reducing Pain, Fatigue, and Flares are Top Treatment Goals for People with Lupus

Retrieved on: 
Monday, June 28, 2021
Medical specialties, Autoimmune diseases, Clinical medicine, Cutaneous lupus erythematosus, Medicine, Lupus, William Osler, Anti-SSA/Ro autoantibodies, Neonatal lupus erythematosus, Lupus Canada

The study, "Patient Experiences, Satisfaction, and Expectations with Current Systemic Lupus Erythematosus Treatment: Results of the SLE-UPDATE Survey," was conducted by the Lupus Foundation of America and Eli Lilly and Company, and highlights the importance of patient reported symptoms and treatment goals to improve quality of life.

Key Points: 
  • The study, "Patient Experiences, Satisfaction, and Expectations with Current Systemic Lupus Erythematosus Treatment: Results of the SLE-UPDATE Survey," was conducted by the Lupus Foundation of America and Eli Lilly and Company, and highlights the importance of patient reported symptoms and treatment goals to improve quality of life.
  • The SLE-UPDATE study is a follow-up study to the Lupus Foundation of America and Eli Lilly and Company UNVEIL survey from 2014 which examined the burden of SLE for patients and caregivers in the US.
  • "The voice of people with lupus is incredibly important when understanding treatment needs.
  • Read the full study here and check out an infographic highlighting findings from the study.