LUPKYNIS + Other Treatments for Lupus Nephritis

This trial examines how well LUPKYNIS works with other treatments to quickly improve kidney health in people with lupus nephritis, a kidney condition related to lupus. Participants will take LUPKYNIS alongside one of three other medications: belimumab, obinutuzumab, or anifrolumab, in addition to mycophenolic acid analog and corticosteroids. The study targets individuals diagnosed with lupus nephritis through a biopsy and who have specific protein levels in their urine. As a Phase 4 trial, it involves an FDA-approved treatment and aims to understand how LUPKYNIS can benefit more patients.

You may need to stop certain medications before joining the trial. Specifically, you cannot have taken B cell targeted therapies (except for belimumab and obinutuzumab) within the past year, cyclophosphamide or certain calcineurin inhibitors within the past 3 months, or other immunosuppressive therapies within the past 30 days or 5 half-lives, whichever is longer. However, you can continue taking mycophenolic acid analogs and corticosteroids.

In previous studies, LUPKYNIS® (voclosporin) was well-tolerated, with no unexpected safety issues reported over three years. However, it increases the risk of serious infections and certain cancers. Most patients, about 86%, experienced some side effects, which were generally expected with this type of medication.

Research shows that belimumab is safe and helps improve kidney health. Reports of serious allergic reactions, such as anaphylaxis, are rare.

Testing has shown that obinutuzumab has a safety profile typical for its class, though some patients may experience serious reactions during the first treatment.

Studies indicate that anifrolumab is generally well-tolerated, but it can weaken the immune system, leading to serious infections in some cases.

Researchers are excited about LUPKYNIS for lupus nephritis because it offers a unique approach compared to traditional treatments like corticosteroids and immunosuppressants. Unlike these standard therapies, LUPKYNIS works by selectively modulating the body's immune response, potentially reducing the risk of long-term damage to the kidneys. Additionally, when combined with other targeted therapies like belimumab, obinutuzumab, or anifrolumab, LUPKYNIS may enhance treatment effectiveness, offering a more comprehensive strategy for managing lupus nephritis. This novel approach could lead to better outcomes and improved quality of life for patients.

Research has shown that LUPKYNIS (voclosporin), which participants in this trial may receive, effectively treats lupus nephritis by quickly lowering protein levels in urine, crucial for kidney health. Studies have found that more patients using LUPKYNIS experience improved kidney function. In this trial, LUPKYNIS will be combined with either belimumab, obinutuzumab, or anifrolumab. Belimumab shows promise by reducing the risk of kidney problems and helping prevent flare-ups of lupus nephritis symptoms. Obinutuzumab enhances kidney health by reducing protein in urine and increasing the number of patients with improved kidney function. Anifrolumab may help reduce the risk of long-term organ damage in people with lupus, although its specific effects on kidneys remain less clear. Each treatment offers a unique approach to managing lupus nephritis, with evidence supporting their role in improving kidney health.¹²⁵⁶⁷