GlaxoSmithKline has kicked off a Phase III trial assessing its lupus drug Benlysta in combination with rituximab in adult patients with the condition.
The firm wants to establish whether rituximab might boost the treatment effect of Benlysta (belimumab), and if the combination provides sustained disease control and possibly clinical remission.
Benlysta was cleared by European regulators back in 2011 for autoantibody-positive SLE, and in June last year GSK published 10-year data showing prolonged control of disease activity in patients taking the biologic.
The trial showed that the percentage of patients with active SLE responding to treatment with the drug increased over time, with an overall response of 65.1 percent at Year 10, while patients were also able to reduce their corticosteroid dose over the time frame.
Benlysta “has already demonstrated its consistent efficacy in reducing disease activity for patients with SLE, with four successful phase III trials,” noted Gijs van den Brink, global head, Immuno-Inflammation Research and Clinical Development, GSK.
“The underlying biology of the disease, combined with the results from a small investigator-sponsored study in severe refractory SLE, provide a strong scientific rationale for initiating this [new] study,” he added.
The company intends to enroll around 200 people in the Phase III BLISS-BELIEVE trial.
