Systemic lupus erythematosus (SLE) is an out-of-control, malignant attack on the body by its own immune system. It can be a horrible illness that may affect virtually every organ of the body. One of the worst things is that it can lead to renal (kidney) failure. Until now, the treatments of SLE have been either symptomatic or "disease-modifying." The second is what we really want: to prevent the illness from progressing. But it has been very difficult to do that, and I have seen some real tragedies in my career.
We now have a new approach that highlights a new approach to illness in general. Students are usually taught that there are diagnostic tests for illnesses like SLE or prostate cancer. The idea of using the tests for treatment is fairly new. So one of the proteins that goes up in prostate cancer becomes the target for treatment.
But what about SLE?
SLE is a chronic inflammatory disease in which the body produces antibodies against the nuclear components of its own cells. The most worrying are antibodies to double-stranded DNA (dsDNA). These antibodies can be triggered by genetics, environmental factors like sunlight and some drugs.
The antibodies attack the body’s cells and tissue, resulting in inflammation and tissue damage. SLE can affect any part of the body, but most often damages the heart, joints, skin, lungs, blood vessels, liver, kidneys and nervous system.
La Jolla Pharmaceutical Company just announced positive interim antibody results from its ongoing double-blind, placebo-controlled randomized Phase 3 trials of Riquent(R) (abetimus sodium). This is a drug candidate for SLE. Analyses of interim antibody data indicate that patients treated with 900 mg or 300 mg per week doses of Riquent had greater reductions in dsDNA antibodies than patients treated with 100 mg per week or placebo. The results showed a significant dose response when comparing all Riquent-treated patients to placebo-treated patients (p < 0.0001), and each Riquent dose group to the placebo dose group (p < 0.0015 for 100 mg, p < 0.0001 for 300 mg and 900 mg).
For people not used to looking at statistics, these are impressive data.
Clearly other analysts feel the same way: the price of the company's shares went up 40% on the announcement.
We shall keep an eye on the development of this new medicine to see if it fulfills this early promise. At this moment the data are very exciting.