15th European Lupus Meeting (SLEuro 2026): Live Updates on SLE Trials, B‑Cell Therapies and New Lupus Treatments | Updates | iPharmaCenter

Roche’s type II anti‑CD20 antibody reduced disease activity in systemic lupus erythematosus in the phase III ALLEGORY trial

Roche’s type II anti‑CD20 antibody, Gazyva/Gazyvaro (obinutuzumab) has delivered positive phase III results in systemic lupus erythematosus, positioning it as a plausible new benchmark for B‑cell‑targeted therapy in this disease.

• At week 52, 76.7% of patients on the antibody plus standard therapy achieved an SRI‑4 response, compared with 53.5% on placebo plus standard therapy (adjusted difference 23.1%).

• At week 52, BICLA response was 62.0% versus 40.1%

• More patients reduced glucocorticoids to ≤7.5 mg/day between weeks 40–52 (80.0% versus 54.1%), and sustained SRI‑4 response from week 40 to 52 was 72.0% versus 46.4%.

• Remission was reported in 35.1% of treated patients versus 13.8% on placebo, and time to first flare by BILAG criteria was longer with the antibody than with placebo.

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Regulatory discussions with agencies such as the FDA and EMA are ongoing to evaluate this anti‑CD20 therapy as a potential option for people with SLE.

Beyond this single trial, ALLEGORY is part of a broader late‑stage programme in immune‑mediated kidney and glomerular diseases, including positive studies in lupus nephritis, idiopathic nephrotic syndrome, and primary membranous nephropathy, collectively indicating that deeper and more sustained B‑cell depletion may translate into meaningful benefits across multiple related conditions.