Friday, 16 Feb 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

Nailfold Capillaroscopy Portends Prognosis in Systemic Sclerosis

Two reports underscore the importance of nailfold capillaroscopy (NFC) in scleroderma and have shown that nailfold capillary drop out was significantly associated with mortality in systemic sclerosis.

Poor Prognosis of the MDA-5 Antibody in Dermatomyositis

Researchers from Hong Kong assessed the clinical associations seen with the anti-melanoma differentiation-associated gene 5 antibody (anti-MDA5 Ab) assay in consecutive patients with dermatomyositis (DM) and polymyositis (PM).

Twenty patients with either DM or PM who were followed in the Rheumatology Clinic of Kwong Wah Hospital, Hong Kong were recruited and underwent testing for the anti-MDA-5 antibody.

Inefficacy of Immunosuppressive Treatments in Systemic Sclerosis with ILD

EUSTAR study results published in Arthritis Research & Therapy show the current state of immunosuppressive use in systemic sclerosis patients with interstitial lung disease (SSc-ILD) to be ill-defined, but that liberal use of glucocorticoids (GC) in SSc-ILD should be discouraged.

ESRD Death Declines in Vasculitis Patients

 

In the past 2 decades, mortality from end-stage renal disease (ESRD) among U.S. patients with granulomatosis with polyangiitis (GPA) has declined significantly, a nationwide study found.

Stroke Risk Confirmed in SLE

The most common cerebrovascular events (CVEs) seen among a large cohort of patients with systemic lupus erythematosus (SLE) were stroke and transient ischemia, and the majority of these events were attributable to the disease itself, a multinational study determined.