Despite current SoC, such as glucocorticoids and immunosuppressants, 60% of lupus patients continue to experience persistent symptoms and severe disease flares. Belimumab is the first medicine specifically developed and approved for SLE in over 50 years .
Results of BLISS-SC (NCT01484496) published in Arthritis & Rheumatology. RCT (n=839 moderate/severe SLE) found that SLE Responder Index response rate at week 52 was higher in patients who received belimumab 200 mg SC plus SoC than in those who received placebo (61.4% vs 48.4%; OR 1.68; 95% CI, 1.25, 2.25; p=0.0006) .
Fourth pivotal trial meets primary efficacy endpoint of SLE Responder Index at week 52. The study in Northeast Asia (n=707) reported that significantly more of the patients on iv belimumab 10mg/kg (54%) achieved reduced disease activity vs those on placebo (40%) (OR 2.03; 95% CI 1.43-2.88; p<0.0001) .
NICE issues TA397. Belimumab is recommended as add-on treatment for active autoantibody-positive systemic lupus erythematosus in adults only if certain conditions are met. This TA relates to the IV formulation, not SC .
GSK reports that results of BLISS-SC study show that a subset of patients with highly-active disease on subcutaneous belimumab 200mg plus standard of care (SoC) had greater reductions in disease activity at week 52 vs. placebo plus SoC arm (64.6% vs. 47.2%), thereby achieving primary endpoint .
In DRAFT guidance NICE recommends belimumab as an option as add-on treatment for active autoantibody positive SLE in adults according to specific criteria.
Pooled analysis results of BLISS-52 and BLISS-76 published online in Arthritis & Rheumatology .
A long term analysis of belimumab has shown low rates of organ damage progression in patients with moderate-to-severe SLE taking drugs for 5 years, regardless of their level of damage at the start of the trial. Interim analysis of data from two pooled, open-label, continuation studies (BLISS-52 and BLISS-76) showed that 85.1% of patients taking Benlysta (belimumab) plus the standard of care showed no organ damage at study years five-six, as measured by change in SLICC Damage Index from baseline, a validated score to quantify organ damage .
Belimumab has patent protection in the US until 2023 and in the EU until 2021. 
Data from the BLISS-SC study presented at a conference showed that weekly SC infusions of belimumab (Benlysta) plus standard of care (SoC) achieves greater reductions in disease activity vs. placebo plus SoC. For the primary efficacy endpoint SRI at Week 52 - 60.8% of patients treated with belimumab plus SoC showed reduced disease activity versus 48.47% of those receiving placebo/SoC. The belimumab regimen also met the secondary target of delaying the time to severe flare (170 days) versus placebo/SoC (116.5 days), and while 18.2% were able to reduce their steroid dose by 25% or more (in those taking more than 7.5mg/day of prednisone) compared to 11.9% of those on placebo/SoC, this did not reach statistical significance .
BLISS-SC. Initially, recruitment appeared to be underway only at sites in the US. Results are expected to be available in the second half of 2014. 
Phase III development of SC-administered belimumab was underway in the EU in patients with SLE. 
NCT01484496 (BLISS-SC) is a PIII, multi-centre placebo controlled RCT of belimumab 200 mg weekly given subcutaneously to 816 subjects with SLE. The primary outcome is SLE Responder Index (SRI) response rate at 52 weeks. A SRI response includes all three of the following: ≥4 point reduction from baseline in SELENA SLEDAI score, no worsening (increase of <0.30 points from baseline) in Physician´s Global Assessment (PGA), and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline. Subjects completing the 52-week double-blind period can enter a 6-month open-label extension in which all subjects receive belimumab 200 mg SC weekly. The study started Nov 11 and is due to complete Sep 14 .