Benlysta’s potential approval has a personal side for me. As a lupus patient who participated in the Phase III clinical trials of Rituxan, I understand the life-changing impacts of a powerful and effective drug treatment. My improvement after receiving two Rituxan infusions was dramatic, shutting down lupus’ attack on my central nervous system and liver, and greatly quieting the overall activity of my disease for almost five years!
Unfortunately, some lupus patients were not helped by Rituxan, and there were a couple of statistically significant deaths of lupus patients who had received it during the clinical trials. Research excitement about use of this drug to treat lupus cooled significantly after 2006 when the news of these brain infection related deaths was released. Although not approved by the FDA for lupus, due to some inconsistent results and these safety concerns, it is now FDA approved and widely used for successful treatment of rheumatoid arthritis.
Although Benlysta is thought to provide less dramatic improvement than what I experienced after receiving Rituxan, it is exciting to finally see the advent of a new drug for lupus. This may be the first new drug approved for lupus in my lifetime, and it might even be available soon to help me.