Benlysta Achieves Sustained Disease Control in Lupus, Concludes GSK’s 10-year Study

Patients with active systemic lupus erythematosus (SLE) were able to control their disease with Benlysta (belimumab) plus standard of care (prednisone), pharmaceutical giant GSK said in announcing the results from a 10-year continuation study.

GSK presented the study’s results at the Annual European Congress of Rheumatology (EULAR 2017), held June 14-17 in Madrid.

U.S. and European authorities have approved Benlysta to treat SLE. The drug, a BLyS-specific inhibitor acts as a human monoclonal antibody, binding to soluble BLyS. Benlysta does not bind immune B-cells directly but inhibits their survival, including of autoreactive B-cells.

The 10-year, open-label clinical trial (NCT00583362) is the longest study to measure the efficacy and safety of any SLE therapy. It evaluated patients who completed the Phase 2 parent 52-week study of Benlysta (NCT00071487) and benefitted from treatment. Of 298 patients in the continuation trial, 131, or 44 percent, remained at year 10. Total Benlysta exposure was 2,154 patient-years.

The percentage of patients responding to treatment with Benlysta increased progressively, the study showed, with an overall response of 65.1 percent at year 10. It also showed that patients were able to decrease corticosteroid intake over time. Of those who received more than 7.5 mg prednisone daily, 32.6 percent had decreased their dose to less than 7.5 mg by year 10. Reducing corticosteroid use is important, since these therapies cause significant side effects.

Since the study had no matched-control group, researchers couldn’t compare treatments for long-term efficacy and safety. However, the prevalence of adverse events remained stable over the 10-year period with a profile consistent with that previously observed for Benlysta.

“In lupus, the underlying disease is always present and symptoms can erupt, or flare, without warning, making it incredibly difficult to manage everyday life,” said David Roth, GSK’s medicines development leader, in a press release. “Unlike most treatments used for SLE, belimumab has a specific mode of action that targets the underlying disease process. It has consistently proven its effectiveness, with four successful pivotal trials in SLE and data now shows that the disease control is sustained, helping to stabilize day-to-day symptoms and improve outcomes for patients in the longer term.”