A new drug is approved, what's next?

We finally get to ask that question about lupus, after the FDA approved Benlysta, the first new drug approved for SLE in over 50 years, in March 2011. Patients and researchers alike are asking questions …  Who needs to take this drug?  How is it different from the medicines that doctors were already using?  How do we know it’s going to work? How do we know that it’s going to work better than those other medications?

Fortunately, many researchers have ideas about where to look for answers, because we know that Benlysta works by reining in a type of immune cells called B cells.  B cells play an important role in the normal immune response, but when inappropriately activated in a lupus patient, they produce harmful elements that cause the damaging effects seen in SLE.  Researchers think that measuring these may provide clues to help us determine whether an individual patient is likely to respond to this particular drug.

So where exactly might these clues be found? One place to look is among the autoantibodies that doctors routinely test for in lupus patients.  B cells also make an arsenal of other factors that they release into the environment around them, boosting the fight against invading germs but also waging war against a lupus patient’s own tissues and organs.  Finally, B cells display tell-tale markers on their outside surface when they are in attack mode.

A number of outstanding scientists have built their careers upon studying B cells and how they contribute to autoimmune disease. They are now poised to study these factors in the context of Benlysta treatment, with the hope of answering our questions.  The approval of this drug is a major milestone, but it is not the end of its story.  The next chapter will hold answers that will allow doctors to use this medication to its greatest benefit in treating patients with SLE.