Author Archives: Lindsey Shapiro

Lupkynis helps protect kidneys with lupus nephritis and high proteinuria

Lupkynis (voclosporin) combined with background lupus treatments better preserved kidney function among a subgroup of lupus nephritis patients with particularly high protein levels in the urine (proteinuria) compared with background therapy alone. Notably, these benefits were observed regardless of patients’ baseline demographic or clinical characteristics, and they were…

Upadacitinib reduces SLE disease activity: Phase 2 trial data

A year of treatment with upadacitinib led to significant disease activity reductions for people with systemic lupus erythematosus (SLE), according to data from the Phase 2 SLEek trial. It was similarly effective when used with the experimental treatment elsubrutinib, in a combination called ABBV-599, the researchers found. These and…

KYV-101 CAR-T cell therapy for lupus nephritis on FDA fast track

KYV-101, an investigational cell therapy from Kyverna Therapeutics, has been granted a fast track designation by the U.S. Food and Drug Administration (FDA) for the treatment of refractory lupus nephritis — a serious lupus complication characterized by kidney damage. Fast track status is granted to experimental therapies for…

Phase 1/2 trial of relma-cel, a CAR T-cell therapy, to open in China

JW Therapeutics has received approval from Chinese authorities to open a clinical trial of its CAR T-cell therapy, relmacabtagene autoleucel (relma-cel), in systemic lupus erythematosus (SLE) patients with moderate-to-severe and treatment-resistant active disease. Although not approved for SLE or other autoimmune disorders, relma-cel is available under the…

Cabaletta’s CAR T-cell therapy cleared for SLE Phase 1/2 trial

The U.S. Food and Drug Administration (FDA) has cleared a Phase 1/2 clinical trial to test CABA-201, Cabaletta Bio’s investigational CAR T-cell therapy, in people with systemic lupus erythematosus (SLE) with or without kidney involvement. Cabaletta asked to launch the trial in the form of an investigational new…

Black SLE patients at 19 times higher risk of early heart disease

Black people with systemic lupus erythematosus (SLE) are at a higher risk of developing heart disease — especially in the early years after their diagnosis — compared with non-Black patients, a new U.S. study found. The risk of cardiovascular disease or CVD was particularly elevated in the first 12…

Low Blood Levels of HCQ, Not the Prescribed Dose, Linked to SLE Flares

Low blood levels of hydroxychloroquine (HCQ) put people with systemic lupus erythematosus (SLE) at higher risk of experiencing disease exacerbations, or flare-ups, a study has found. “We found that low HCQ blood levels predicted lupus flares,” researchers wrote, noting that low levels can reflect poor treatment adherence but also individual…

Ventus to Advance cGAS Inhibitor as New Treatment for Lupus

Ventus Therapeutics plans to develop a new treatment candidate for lupus and other inflammatory diseases marked by the activation of the type 1 interferon immune system pathway, the company recently announced. Called VENT-03, the investigational treatment will target cGAS, a protein whose activation has been implicated in…