Injected Benlysta Is Effective Alternative to IV for Treating Lupus, Phase 3 Trial Shows

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by Alice Melão |

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An injected formulation of Benlysta (belimumab) is a safe and effective lupus treatment, according to a Phase 3 clinical trial that tested an alternative to administering the therapy intravenously.

Researchers reported the results of the 52-week BLISS-SC trial in Arthritis & Rheumatology. The article was titled “Efficacy and Safety of Subcutaneous Belimumab in Systemic Lupus Erythematosus: A Fifty‐Two–Week Randomized, Double‐Blind, Placebo‐Controlled Study.

Two other Phase 3 trials, BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384), had shown that Benlysta was effective when combined with standard of care treatments.

Based on these results, the U.S. Food and Drug Administration and the European Medicines Agency approved its use against lupus in combination with steroids, malaria treatments, immunosuppressants, and non-steroid anti-inflammatory medicines.

Human Genome Sciences developed Benlysta. It became GlaxoSmithKline’s property when the pharmaceutical giant bought Human Genome in 2012.

Until Glaxo developed an injected formulation, doctors had to administer Benlysta intravenously. That route can be a challenge, with some patients deciding not to stick to the treatment.

“Patients must visit a clinic or infusion center every two weeks for the first three doses and then every four weeks thereafter, thereby incurring substantial costs in time for travel to/from the drug-administering site, time for the infusion itself, and time for post-infusion monitoring,” the researchers wrote.

In the Phase 3 BLISS-SC trial (NCT01484496), which was a collaboration of GlaxoSmithKline and Human Genome Sciences, researchers used an auto-injector to administer the new formulation.

The study included 839 adults with lupus. About two-thirds, or 556, received 200 mg of Benlysta and standard therapy for 52 weeks, while 280 received a placebo and standard care. One hundred fifty-nine, or 19 percent of the patients, withdrew from the study. They included 93, or 16.7 percent, of the Benlysta group, and 66, or 23.6 percent, of the control group.

Sixty-one percent of those receiving subcutaneous Benlysta responded to the combo treatment, versus 48 percent of those receiving standard of care without Benlysta. Researchers used SLE Responder Index scores to determine which patients responded.

Benlysta patients also showed a 49 percent improvement in the time it took between one flare-up of the disease and the next, and in their risk of experiencing a severe flare. In addition, more patients in the Benlysta group were able to reduce their steroid therapy use, compared with the placebo group.

Researchers saw no significant differences in side effects between the groups. Eleven percent of the Benlysta groups reported serious adverse events, compared with 16 percent of the placebo group.

“In patients with moderate-to-severe SLE, weekly SC [subcutaneous] doses of belimumab 200-mg plus standard SLE therapy significantly improved their” response score, “decreased severe disease flares as compared with placebo, and had a safety profile similar to placebo plus standard SLE therapy,” the team wrote.

The researchers said they believe “the ability of patients with SLE to administer their medication away from the clinic will provide a more convenient treatment regimen for belimumab [Benlysta], which may make it a more viable treatment option for some patients.”