ADX-097, potential AAV therapy, fares well in healthy volunteers

ADX-097, an experimental tissue-targeted therapy that Q32 Bio is developing for ANCA-associated vasculitis (AAV) and other diseases marked by overactivity of the immune complement system, was well tolerated in a Phase 1 clinical trial involving healthy volunteers. The study’s data also indicated that ADX-097 showed a favorable pharmacological…

The long-term use of Nucala (mepolizumab) reduces disease activity and the need for standard glucocorticoids, while improving survival, in people with eosinophilic granulomatosis with polyangiitis (EGPA), the rarest type of ANCA-associated vasculitis (AAV). These are the findings of a real-world study in Japan that compared outcomes between 37…

The Vasculitis Foundation has announced the launch of a new support group for young adults with vasculitis, a group of autoimmune conditions that includes ANCA-associated vasculitis (AAV). The group will promote connections among young adults, from 18 to 30 years of age, living with vasculitis, which is marked by…

People with ANCA-associated vasculitis (AAV) have a higher risk of cardiovascular diseases and related mortality than people without the disease, according to a systematic review and meta-analysis of published studies. For example, the risk of venous thromboembolism, a blood clot that develops in a vein, was three times higher…

A Phase 1 clinical trial evaluating the safety and preliminary efficacy of Adicet Bio’s CAR T-cell therapy ADI-001 in people with autoimmune diseases, including ANCA-associated vasculitis (AAV), has started recruiting certain participants — and it’s expected to enroll AAV patients by the end of the year — the…

Patterns of lung damage on CT scans may help predict disease outcomes in people with ANCA-associated vasculitis (AAV) and determine which patients should receive more intensive treatment, a study in Germany suggests. Particularly, ground glass opacities (GGO), which are white diffuse regions due to fluid, airway collapse, tissue scarring,…

A European Medicines Agency (EMA) committee has issued a positive opinion recommending the approval of Fasenra (benralizumab) as an add-on treatment for adults with hard-to-treat eosinophilic granulomatosis with polyangiitis (EGPA). If approved for the recommended indication, the AstraZeneca therapy would be a new option for patients in…

High blood levels of the syndecan-1 protein, known to promote the survival of antibody-producing B cells, may help identify ANCA-associated vasculitis (AAV) patients with high disease activity — and those at risk of a poor prognosis — a new study suggests. The researchers defined two cut-off values of syndecan-1…

The U.S. Food and Drug Administration (FDA) has approved Fasenra (benralizumab) for treating adults with eosinophilic granulomatosis with polyangiitis (EGPA), a rare form of ANCA-associated vasculitis (AAV). Developed by AstraZeneca, Fasenra was already approved in more than 80 countries, including the U.S., as an add-on treatment…

Rituximab may be associated with a higher risk of serious adverse events, particularly infections, in people with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). Time to first serious adverse event, as well as to second and multiple serious adverse events, is significantly shorter for patients treated with rituximab…