Lupus drug Benlysta succeeds in clinical trial

The drug, Benlysta, acts as a kind of biological volume control, dialing down the intensity of the immune response that attacks lupus patients' tissues, often wreaking havoc in vital organs.

All 865 patients in the trial were given standard therapy for lupus, with steroids as a mainstay of treatment. Researchers found that 52% of patients on a low dose of Benlysta and 58% of those taking a high dose of the drug, along with standard therapy, experienced a significant improvement in their disease, compared with just 43% of those taking standard therapy and a placebo.

More Benlysta patients were able to reduce their steroid dose, and with it the bloating and other side effects of steroid use, company officials said.

The main goal of the trial was to show a four-point or greater improvement in disease symptoms as measured by a scale known as Selena Sledai. A four-point reduction on a scale of 10 constitutes a good, or meaningful, response. The lower the score the less disease activity a patient has. All patients entering the trial had a score of six or higher.

The trial also required that patients did not experience a worsening of their disease in any organ beyond the originally affected one. The trial met all of these goals at both doses.