Q: What is Benlysta?
A: Benlysta (belimumab) is a new drug that was developed specifically to treat systemic lupus. It works by calming down the hyperactive immune system of lupus by inhibiting a protein called “B lymphocyte stimulator (BLyS)” believed to increase inflammatory reactions that attack and damage the body’s own healthy tissues.
Q: I have lupus. Will Benlysta work for me?
A: Studies show that Benlysta can lessen signs and symptoms of moderate to severe disease in many people with active lupus, and also lessen the need for as many (or as much) other lupus drugs such as prednisone. But Benlysta is not for everybody with lupus. Ask your doctor whether you might benefit from it based on the FDA’s ruling.
Q: Is Benlysta safe? Does it cause side effects like the other medicines I take for lupus?
A: The FDA found that there were likely side effects with Benlysta, but that they were acceptable enough given the apparent benefits of the drug.
Hundreds of people with lupus involved in the clinical trials had reactions whether they were given Benlysta or a “dummy drug” (placebo). Side effects such as headache, muscle pain, infections, and flu—and also much more serious reactions such as suicide were slightly higher in the groups taking Benlysta—but in the end this may have been due to chance, because roughly the same number of people taking Benlysta as those taking a placebo had these problems.
Overall, BENLYSTA has a pretty good safety profile.
Q: How do you take Benlysta? Is it a pill?
A: Benlysta is a one-hour IV (intravenous infusion) every four weeks, so you’d get it at a doctor’s office or lupus clinic.
Q: How can I get Benlysta in the U.S.? Can I get it right away?
A: Ask your doctor about getting a prescription for it, and/or consider participating in a follow-up trial of the drug.
Q: How can I get Benlysta in Europe and elsewhere?
A: A decision on approval of the drug is expected from authorities in Europe in the second half of 2011. The drug producers also have applied for approval in Russia, Brazil, Australia, Switzerland, The Philippines, and Canada.