DETERx technology manufactured the product, which addresses common methods of abuse, including chewing, crushing and/or dissolving, and then snorting, injecting or taking it orally.
Obinutuzumab for Lupus Nephritis
Obinutuzumab, a CD20-directed cytolytic antibody that is FDA approved for treating chronic lymphocytic leukemia along with chlorambucil, is being investigated to treat lupus nephritis.6
The study, a Phase 2 clinical trial known as NOBILITY, will compare the safety and efficacy of 1,000 mg obinutuzumab in combination with corticosteroids and mycophenolate vs. corticosteroids and mycophenolate with placebo in patients with International Society of Nephrology (ISN)/Renal Pathology Society (RPS) 2003 Classification of Lupus Nephritis Class III or IV proliferative lupus nephritis. The primary outcome measure of NOBILITY is the percentage of patients who achieve complete renal response at Week 52.
Sub-Q Belimumab for SLE
BLISS-SC is a Phase 3 multicenter, randomized, double-blind, placebo-controlled, 52-week study to evaluate the efficacy and safety of belimumab administered subcutaneously to patients with active autoantibody-positive systemic lupus erythematosus (SLE) receiving standard therapy.7 In this study, 200 mg belimumab (Benlysta) administered weekly and subcutaneously plus standard of care were shown to have significantly greater reductions in disease activity compared with placebo plus standard of care (61% vs. 48%).
The primary efficacy end point was the Systemic Lupus Erythematosus Responder Index response rate at Week 52.8 The belimumab regimen also met the secondary end point of delaying the time to severe flare (170 days) vs. placebo and standard care (117 days). Additionally, 18% of patients were able to reduce their steroid dose by 25% or more (for those taking >7.5 mg prednisone daily) compared with 12% of patients receiving the placebo and standard care regimen, which was not statistically significant.
Etanercept Biosimilars
In a 52-week clinical study, an investigational biosimilar for etanercept, SB4, showed lasting efficacy (including radiographic progression), immunogenicity and safety.9 This trial was a randomized, double-blind study in adults with moderate to severe rheumatoid arthritis (RA), despite methotrexate treatment.
Five hundred ninety-six patients were randomized to receive either SB4 (n=299) or Enbrel (etanercept; ETN) (n=297). The ACR20 response rate was 81% in patients who received SB4 vs. 82% in those who received ETN. Additionally, the ACR50 and ACR70 response rates were slightly higher for SB4 compared with ETN.
The safety profiles were also comparable. One treatment-emergent adverse event occurred in 59% of SB4-treated patients vs. 60% of ETN-treated patients; and injection-site reactions occurred in 4% vs. 18% of SB4- and ETN-treated patients, respectively (P<0.001). At Week 52, at least one anti-drug antibody result occurred in 1% and 13% of SB4- and ETN-treated patients, respectively (P<0.001). The serious infection, tuberculosis and malignancy rates were all comparable.
