New analyses show Benlysta may aid flare control, kidney health
Multiple studies show improved outcomes in SLE and lupus nephritis patients
Treatment with Benlysta (belimumab) can help people with lupus avoid disease flares and reduce their need for glucocorticoids, according to new analyses of clinical trial data announced by the therapy’s maker, GSK.
Roger Abramino Levy, MD, PhD, senior global medical director for rheumatology at GSK, noted that the therapy “has accumulated over 14 years of clinical and safety data, from a robust clinical trial program and real-world experience, reinforcing its established role as an effective and well-tolerated option for patients with [lupus].”
“Collaboration among patients, advocacy groups, academic institutions, and industry — built on respect and transparency — is essential to making real advancements in lupus care,” Levy said in an interview with Lupus News Today, where he discussed results presented at this year’s American College of Rheumatology (ACR) Convergence and American Society of Nephrology (ASN) Kidney Week. “Through joint efforts, research moves forward, access to new treatments expands, and patient perspectives remain central throughout the clinical process.”
How Benlysta works to calm B-cell activity in lupus
Lupus is driven by antibodies that attack the body’s own healthy tissues. Antibodies are immune proteins produced by B-cells, a type of immune cell.
Benlysta works by reducing B-cell activity. It blocks B-lymphocyte stimulator (BLyS), a protein that helps activate these cells. The therapy is given either by infusion into the bloodstream or by injection under the skin. It’s approved in the U.S. for people age 5 and older with systemic lupus erythematosus (SLE), the most common form of lupus, or lupus nephritis (LN), a severe form of the disease marked by kidney inflammation.
Benlysta has been tested in numerous clinical trials. In one new analysis, scientists reviewed data from nearly 1,000 adults with SLE who participated in one of five trials (NCT00424476; NCT00410384; NCT01345253; NCT01484496; NCT01632241). The analysis compared outcomes in 552 people treated with Benlysta and 358 people receiving immune-suppressing therapies. All patients also received antimalarials and glucocorticoids.
Results showed that significantly more patients on Benlysta were responders on a standardized disease measure called the SRI-4. They also had fewer disease flares and a longer time to the first flare.
Collaboration among patients, advocacy groups, academic institutions, and industry — built on respect and transparency — is essential to making real advancements in lupus care.
Data from the five-trial analysis also showed that patients taking Benlysta tended to reduce their glucocorticoids doses, while those receiving other immune-suppressing drugs tended to increase their glucocorticoid dose. A separate real-world analysis of 143 LN patients found that more than 80% reduced their glucocorticoid dose after starting Benlysta. Glucocorticoids, often called GCs, mimic the hormone cortisol and can reduce inflammation, but can also cause problematic side effects.
“While GCs are effective at rapidly controlling disease activity, their use is associated with a range of acute and long-term adverse effects,” Levy said. “In the short term, patients may experience weight gain, mood fluctuations, and increased susceptibility to infections. Over time, chronic GC use can lead to irreversible complications such as osteonecrosis (the death of bone tissue due to a temporary or permanent loss of blood supply), osteoporotic fractures, cardiovascular events, and ocular damage.”
Given these risks, “it is crucial to limit GC therapy to the minimum effective dose and duration — ideally discontinuing them altogether or maintaining doses below 5 mg/day and trying to stop completely,” Levy said.
He added that, overall, the five-trial analysis suggests “Benlysta can be added to antimalarials and GC without background immunosuppressants, offering improved disease control, fewer flares, reduced cumulative GC doses, and a better safety profile with fewer infections and serious adverse events.” Levy said these findings align with recent recommendations for lupus treatment.
Separate analysis shows kidney benefits for patients with lupus nephritis
In a separate new analysis, researchers evaluated outcomes from BLISS-LN (NCT01639339), a trial that tested Benlysta against a placebo on top of standard care in more than 400 LN patients. The analysis specifically examined outcomes for the subset of people receiving mycophenolate mofetil (MMF), an immune-suppressing drug commonly used in standard LN treatment.
Results showed that patients given Benlysta had fewer kidney flares and higher rates of complete renal response, which Levy said are important markers of improved kidney health. “Overall, this subgroup analysis underscores Benlysta’s value as an adjunct to MMF for proliferative LN,” he said.
GSK is now running two Phase 4 trials to gather more data on Benlysta. One, called OBSErve-LN (NCT06527872), aims to collect long-term data on LN patients treated with Benlysta in real-world settings. Recruitment is ongoing at a site in North Carolina; the study is expected to expand to China, Japan, and Europe.
The other trial, BE-EARLY (NCT06411249), is collecting data on Benlysta’s use in SLE patients who are less than two years out from diagnosis and who haven’t responded to first-line treatments. The study is recruiting patients at dozens of sites worldwide.
“The intention behind BE-EARLY is to find out whether starting Benlysta shortly after diagnosis could lead to better overall outcomes, such as reduced disease activity, decreased organ damage, less reliance on steroids, and improvements in quality of life,” Levy said.
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