Long-term data for GlaxoSmithKline, Human Genome's lupus drug presented at EULAR

GlaxoSmithKline's development partner, Human Genome Sciences, announced Thursday that patients with systemic lupus erythematosus (SLE) who received intravenous Benlysta (belimumab) had sustained improvement in disease symptoms as well as reduced frequency of flare-ups through four years of treatment. The data from the long-term Phase II continuation trial were presented at the congress of the European League Against Rheumatism (EULAR).

The randomised trial initially enrolled 449 patients with active SLE who received standard therapy, plus one of three doses of Benlysta or placebo, over a treatment period of 52 weeks. All patients who chose to participate in a 24-week extension phase in the study started taking Benlysta, and after 76 weeks, 296 patients chose to continue taking the drug in the long-term continuation phase. Results showed that from week 52 to week 208, the response rate to treatment with Benlysta increased from 46 percent to 57 percent. During the same period, overall frequency of disease flare-ups declined from 62 percent to 16 percent, while severe flares due to SLE fell from 8 percent to 1 percent, Human Genome noted.

The company, which saw its shares rise as much as 29 percent on news of the findings, indicated that it expects to report late-stage results for Benlysta, formerly known as LymphoStat-B, starting in July.

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