A long-term analysis of GlaxoSmithKline’s Benlysta has shown low rates of organ damage progression in patients with moderate-to-severe systemic lupus erythematosus (SLE) taking the drug for five 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.
Patients with SLE are at risk of irreversible organ damage that builds up over over time and is linked with an increased risk of death. Benlysta is a human monoclonal antibody belonging to the BLyS-specific inhibitor class of drugs, targeting a naturally occurring protein believed to play a role in the production of antibodies which attack and destroy the body’s own healthy tissues.
“Whilst this is an open-label continuation study, the results are very encouraging and suggest that use of more targeted therapies may slow progression of irreversible long-term damage for lupus patients,” said Professor Ian Bruce, University of Manchester, UK. “Further studies to examine this question further would be warranted.”
Long-term safety of the drug was also consistent with Benlysta’s known safety profile. Overall, 433 (43.4%) patients experienced a drug-related adverse event, the most commonly reported being infections/infestations (282, 28.3%) and gastrointestinal disorders (139, 13.9%).
Opportunistic infections were reported in 23 (2.3%) patients, four cases of which were serious, and herpes zoster infection was reported for 87 (8.7%) patients, seven cases of which were serious.
In Europe, Benlytsa is licensed as an add-on therapy in adult patients with active autoantibody-positive SLE, with a high degree of disease activity, despite standard therapy.