Kyverna Therapeutics has submitted an investigational new drug (IND) application asking regulators for permission to begin clinical testing on KYV-101, an experimental cell therapy for lupus nephritis — a severe manifestation of lupus that causes kidney damage. The company is actively working with sites in the U.S. and…
Using clinical data collected over time, two machine learning computer models were found to accurately predict inpatient hospitalization due to systemic lupus erythematosus (SLE) — the most common form of lupus. One method was most accurate in using short-term clinical assessment data to foretell future hospitalizations, while the other…
The first participant has been dosed in a pivotal Phase 2/3 trial testing Biogen’s anti-inflammatory medication litifilimab (BIIB059) in people with cutaneous lupus erythematosus (CLE), the company announced. The study, called AMETHYST (NCT05531565), is recruiting adults with CLE, whose disease is active despite standard antimalarial treatment, at…
Equillium’s investigational antibody-based treatment, itolizumab (EQ001), led to significant reductions in urine protein levels — a marker of kidney dysfunction — in systemic lupus erythematosus (SLE) patients with active lupus nephritis, according to an interim analysis from the type B portion of the Phase 1b EQUALISE clinical trial.
Antibodies mounted against COVID-19 in the three to six months following vaccination were lower in patients undergoing treatment for lupus than in healthy people, a study has found. Patients with untreated lupus (also called systemic lupus erythematosus, or SLE) showed a similar level of antibodies as healthy people. Fewer…
Telitacicept, a B-cell-targeting therapy developed by RemeGen, outperformed a placebo at reducing the severity of systemic lupus erythematosus (SLE) in a Phase 3 clinical trial in China, the company announced. “We are delighted with the news of the preliminary results of the Phase III confirmatory study of our proprietary…
The European Commission has approved Lupkynis (voclosporin) to treat active lupus nephritis, a serious complication of systemic lupus erythematosus (SLE) that is characterized by kidney inflammation. The approval is valid in all European Union (EU) member states, as well as Iceland, Liechtenstein, Norway, and Northern Ireland. Lupkynis received a similar…
DxTerity Diagnostics’ interferon-1 gene signature test, which can be used to help guide treatment decisions for people with systemic lupus erythematosus (SLE), is now available for use in all 50 U.S. states, the company has announced. “It is our mission to transform patient care with precision diagnostic tools that…
Active lupus nephritis — kidney inflammation as a result of lupus — is associated with a much higher risk of pregnancy complications, such as fetal loss and preeclampsia, according to a new analysis. The study also showed pregnancy complications are more common in Black women with lupus than among…
Litifilimab (BIIB059), Biogen’s investigational antibody-based treatment for systemic lupus erythematosus (SLE), significantly reduced the number of swollen and tender joints in people with the autoimmune inflammatory disease over six months, new trial data show. With these positive results, the treatment candidate met the main goal of part A of the…