GlaxoSmithKline has presented promising late-stage data on a subcutaneous formulation of its lupus drug Benlysta in a subset of patients with highly-active forms of the disease.
Results of the BLISS-SC study, unveiled at the Annual European Congress of Rheumatology (EULAR), show that patients with highly active systemic lupus erythematosus (SLE) experienced a significantly greater response to Benlysta (belimumab) 200mg, administered subcutaneously, plus standard of care (SoC) versus placebo/SoC.
According to the data, patients in the Benlysta group had significantly greater reductions in disease activity at Week 52, compared to those in the placebo arm (64.6% compared to 47.2%, respectively), thereby achieving the primary endpoint.
These findings are consistent with those observed in the pivotal Phase III BLISS clinical trial programme for Benlysta administered intravenously, its approved formulation on Europe for highly-active SLE, which is associated with symptom flares and a range of organ manifestations in patients.
On secondary endpoints, patients in the Benlysta group showed a 62% reduction in their risk of experiencing a severe flare compared to those in the placebo group; 14.1 percent and 31.5 percent (respectively) had a severe flare during the course of the study.
Also, in those receiving more than 7.5mg/day of prednisone, 20.7 percent of patients in the Benlysta group were able to reduce their steroid dose by 25 percent or more, compared with 11.4 percent of those in the placebo group, though this difference was not deemed statistically significant (p=0.0844), the firm noted.
"Research suggests that controlling this disease activity plays an important role in improving patient outcomes," noted Professor Andrea Doria, University of Padua, Padua, Italy. "The range of clinical benefits seen with Benlysta in this sub-set of patients with more active lupus provides valuable insights for clinicians about disease characteristics that may help inform the potential response to treatment and improve certain outcomes for patients living with this debilitating disease."