New results from a study of a drug called Gazyva (obinutuzumab) showed that it significantly reduced disease activity in adults with systemic lupus erythematosus (SLE). The drug was developed by Genentech and is sold under the brand names Gazyva® and Gazyvaro®.
The purpose of this Phase III study known as ALLEGORY,) was to learn whether Gazyva was safe and could work in reducing SLE disease activity if taken along with people’s current medications (called standard of care therapy). People who participated in the study had active, autoantibody-positive SLE.
Some participants in the study received Gazyva along with their regular lupus medications while others received their regular medications plus a placebo (a lookalike substance without the medicine). Neither the study participants or the doctors knew who received which therapy until the end of the study.
Participants in the study who received Gazyva had greater improvements in controlling their SLE compared to standard of care therapy by itself. The study successfully achieved its main goal, which was that more participants had at least a four-point improvement in the SLE Responder Index 4 (SRI-4) after one year (52 weeks) with Gazyva compared to those receiving standard of care therapy + placebo. Gazyva may also delay or prevent further organ damage in people with SLE.
Gazyva®/Gazyvaro® recently received FDA approval for the treatment of lupus nephritis (LN) in adults. If approved for SLE, it would be the first anti-CD20 therapy specifically designed to target B cells, an underlying driver of the disease. Learn more about SLE.
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