Friday, 22 Jun 2018

You are here

Benlysta FDA Approved for Sub-Q Use in Lupus

The US Food and Drug Administration (FDA) has approved a new subcutaneous formulation of Benlysta (belimumab) for use in active, autoantibody‑positive Systemic Lupus Erythematosus (SLE) patients. While the intravenous formulation was first approved in 2011, this becomes the first subcutaneous injectable treatment option SLE.

Patient may now receive a once weekly injection of 200mg, from either a single-dose prefilled syringe or from a single-dose autoinjector.

The approval is based on data from the BLISS-SC phase III pivotal study of more than 800 patients with active SLE, which measured reduction in disease activity at Week 52 in patients receiving belimumab plus standard of care, versus those receiving placebo plus standard of care (assessed by SRI, a composite measure of efficacy in lupus).

Benlysta subcutaneous formulation will be available in specialty pharmacies in the US in late August.

Benlystas worldwide sales were $398 million in 2016, with over 90% of sale from the USA.

 

Disclosures: 
The author has no conflicts of interest to disclose related to this subject

Add new comment

More Like This

Abatacept Misses in Lupus Nephritis

Dr. Richard Furie, MD, of Northwell Health in New York, presented the findings ofa large phase III trial of abatacept (Orencia) in lupus nephritis showing the agent failed to achieve a complete renal response.

Data presented at EULAR 2018 showed that at one year, a total of 35.1% of patients receiving abatacept achieved complete renal response, as did 33.5% of those randomized to placebo (P=0.73). 

The Stress - Autoimmune Disease Connection

"Can stresss be the cause of my autoimmune disease?" is an often launched question met with shrugs of uncertainty or strongly held beliefs rooted in bias moreso than fact.

Swedish investigators have analyzed a large registry cohort and shown that exposure to stress-related disorders yields a significantly increased risk of autoimmune disease. They analyzed 106,464 patients with stress-related disorders, with 126,652 full siblings, and over a million non-stressed matched controls to assess a future risk of autoimmune disease.

The Microbiome and Lupus Connection Reviewed

In the current issue of the New England Journal of Medicine, Drs. James Rosenbaum and Gregg Silverstein review the pathogenesis of systemic lupus erythematosus (SLE) from the viewpoint of a dysbiolsis.

The complexity of the trillions of organisms that constitute our microbiome underscores its multiplicity of functions, including nutrient, metabolic and immune shaping functions.

SPAR Predicts ILD Progression in Systemic Sclerosis

The development and progression of interstitial lung disease in systemic sclerosis can be an ominous finding. A new analysis of two independent clinical trial cohorts shows that oxygen saturation (SpO2) < 94% after 6 minute walk time (6MWT) and the presence of arthritis predicted the development of ILD in SSc.

Low Disease Activity in Lupus Limits Damage

Patients with systemic lupus erythematosus (SLE) who were assessed as being in a low disease activity state during more than half of clinical visits had a decrease in organ damage events of approximately 50%, a retrospective study found.