Belimumab continues to show a favorable risk-benefit profile in adults with systemic lupus erythematosus (SLE), according to safety data from six clinical trials. Researchers noted the findings “add to the evidence base supporting a positive benefit-risk profile of belimumab in the treatment of adult patients with SLE.” Data from…

The U.S. Food and Drug Administration (FDA) has extended the use of Benlysta (belimumab), given on top of standard therapy, to treat children ages 5 to 17 with active lupus nephritis, a serious form of kidney inflammation caused by lupus. Benlysta is the first FDA-approved treatment for pediatric lupus…

Adding Benlysta (belimumab) to standard therapy increased the percentage of people with active lupus nephritis who experienced improved renal function in a Phase 3 trial. The BLISS-LN study (NCT01639339) was designed to evaluate Benlysta’s safety and efficacy in people with active lupus nephritis, a common and…

The U.S. Food and Drug Administration (FDA) has approved, under priority review, the use of Benlysta (belimumab) for the treatment of children age 5 and older with systemic lupus erythematosus (SLE). Benlysta is a monoclonal human antibody designed to bind and block the activity of the B-lymphocyte…

Systemic lupus erythematosus (SLE) patients treated Benlysta (belimumab) together with standard of care showed significantly lesser evidence of long-term organ damage than those given standard of care alone, a review study reports. The research, “Organ damage in patients treated with belimumab versus standard of care: a…

Patients participating in Phase 3 clinical trials testing new therapies for systemic lupus erythematosus (SLE) are not necessarily representative of real-world patient populations, according to a new report. Even if the therapies being investigated reach the market, real-world experiences may differ significantly from trial results because many lupus patients…

GSK is starting a Phase 3 trial of Benlysta (belimumab) in combination with Rituxan (rituximab) for treating patients with systemic lupus erythematosus (SLE). The ability of the combination to provide sustained disease control or remission will be tested. Benlysta is the only approved biological medication…

Long-term use of Benlysta (belimumab), an approved therapy, is both safe and effective, reducing disease activity in most systemic lupus erythematosus patients, according to a study that followed patients in the U.S. for seven years. The multicenter extension study involved patients who had completed 72 weeks of treatment in the BLISS-76…

A new approach to treating lupus, based on attacking a wide array of disease-implicated molecular pathways, showed promise in a new study in mice. The target is NF-κB-inducing kinase (NIK), which mediates the function of proteins in the tumor necrosis factor (TNF) family. Members of the family are known to be implicated in…

Benlysta (belimumab) used in combination with standard of care significantly improved disease activity and reduced prednisone use in patients in Northeast Asia with systemic lupus erythematosus (SLE), a Phase 3 clinical trial found. While the therapy is already approved in the U.S. and Europe for patients with active, autoantibody-positive SLE receiving standard…