June 23, 2017
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Belimumab plus standard lupus therapy seen as safe, effective over 10 years

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MADRID — Belimumab plus standard therapy was safe and effective over 10 years in patients with lupus, according to findings presented at the EULAR Annual Congress.

“In lupus, the underlying disease is always present and symptoms can erupt, or flare, without warning, making it incredibly difficult to manage everyday life,” David Roth, MD, MSCE, medicines development leader of R&D Immuno-Inflammation at Glaxo Smith Kline, said in a company release. “Unlike most treatments used for [systemic lupus erythematosus 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.”

Roth and colleagues performed a continuation trial of 298 patients with SLE who took belimumab and standard SLE therapy (SOC), 131 of whom remained until year 10.

They found adverse events remained the same or declined during this period. There were two deaths due to pseudomonal lung infection and cytomegaloviral pneumonia. , 72.6% of patients experienced a British Isles lupus assessment group (BILAG) flare and 41.9% had a severe flare. Prednisone dose also declined during the study period. Of those who received at least 7.5 mg of prednisone per day at baseline, 32.6% had lowered their dose to under 7.5 mg by year 10; whereas, 9.5% of patients had their dose increase. — by Will Offit

References:

Wallace DJ, et al. Abstract #OP0108. Presented at: EULAR Annual Congress; June 14-17, 2017; Madrid.

gsk.com/en-gb/media/press-releases/gsk-announces-results-from-10-year-continuation-study-showing-sustained-disease-control-with-benlysta-belimumab-in-sle/

 

Disclosure: Roth reports he is a shareholder and employee of Glaxo Smith Kline.