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The Breakdown List About: Benlysta


The Good

The Bad

Where did it come from?

How does it work?



doctor_prescribing_medicationI have been listening to all this Benlysta talk.  Have you?  If you haven’t heard by now, Benlysta is the first FDA approved drug in over 50 years that has been designed specifically for the treatment of lupus.  It is a non-steroidal biologic therapy that is given as an infusion.  It is supposed to stop and prevent future BLys cells in your immune system that make lupus active and cause lupus flares.

Wow, a non-steroidal wonder drug?  Sign me up!  Well, wait… there has to be a catch right? And what are the side effects of this magic medicine?  Where did this elixir come from and how much does it cost?  Below is a breakdown “list” of the good and bad things about Benlysta.  


The Good:

  • It is not a steroid.
  • It can work in conjunction with your other lupus medications.
  • It is the first lupus treatment approved by the FDA in over 50 years.
  • Studies have shown it can reduce lupus activity.
  • It is the best-studied medicine to treat SLE.
  • It offers hope to those who haven’t responded well to the traditional lupus treatments.  
  • Studies have shown it is especially helpful for those suffering with fatigue, arthritis and cutaneous lupus.  
  • It can help lower your need to take steroids. Testing showed a 55% decrease in steroid use over 3 years.  

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The Bad:

  • It can be expensive!  The molecules they use for the biologic process are fragile, and it’s given by injection or through an IV, so it’s costly.  And there is no generic version available.  
  • The most common side effects of Benlysta are: nausea, diarrhea, fever, headache, stomach pain, vomiting, sore throat, stuffy nose, cough, sleeping issues, leg or arm pain, depression, and UTI.
  • It is not recommended for people who have active/severe lupus nephritis or central nervous system lupus.  This is mainly because people with these complications were not allowed to participate in the Benlysta clinical trials.  
  • It has not been studied in combination with other biologic medications.
  • In 2 of 3 studies, fewer African Americans who received Benlysta responded to treatment compared to African Americans who did not receive treatment. This doesn’t necessary mean that it won’t work for African Americans, it just hasn’t been studied enough to prove in the FDA study whether it works well or not.  
  • It cannot be taken during pregnancy or while breast-feeding.  
  • Like other immunosuppressants, there may be an increased risk of infections.

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test tubes scientistsWhere did it come from?

BENLYSTA was developed by Human Genome Sciences (HGS) and GlaxoSmithKline (GSK).  It was approved by the FDA on March 9, 2011. HGS is now owned by GSK.

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How does it work?

Back in 1996, scientist’s identified a protein called BLys (B-lymphocyte stimulator).  Studies have shown that there is a connection between higher levels of BLys and lupus disease activity.  Benlysta helps by binding to the BLys cells and prevents them from making more.  

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Auto-Injector Version

Recently, an auto-injector version of Benlysta has been introduced to the market.  It has proven beneficial since intravenous administration of Benlysta can only be performed in a clinic, whereas,  the auto-injector device can be applied at home under the skin.

A recent study took a look at this new form of the drug and evaluated SLE patients’ satisfaction, ease and convenience of use of the device. Happily, around 40% of those who filled out the survey reported improvements in symptoms using the new auto-injector compared to the traditional IV administration.  For more information on this study, click here. 


Lupus is a complicated disease which affects every person differently.  That means that Benlysta may be a wonder drug for some, but not for all.  However, it is so nice to have another treatment option in mix!  Particularly, one that has been studied more than any other primary “lupus” drug out there.

Best advice:  Be open and honest about your symptoms with your doctor and with any side effects you may experience after taking it.  Be smart with weighing the pro’s and con’s before starting Benlysta.  


NOTE:  While in the process of writing this blog, I became aware of the Benlysta inventory shortage.  After contacting GSK, it appears that the issue is a temporary issue, and has been resolved (for the most part).  Although, the availability of Benlysta at your doctor’s office may vary over the next few months until the supply is fully re-established.  If you are having issues with your treatments, contact GSK Response Center at 1-888-825-5249, Monday-Friday, 8:30 am – 5:30 pm ET.


Sources: benlysta.com/guide/index.htmllupus.org/answers/entry/what-do-i-need-to-know-about-benlystawebmd.com/lupus/news/20110309/new-lupus-treatment-benlysta-faqThe Lupus Encyclopedia, Dr. Donald Thomas, Jr. M.D.., FACP, FACR, 2014 John Hopkins University Press

*All images unless otherwise noted are property of and were created by Molly’s Fund Fighting Lupus. To use one of these images, please contact us at [email protected] for written permission; image credit and link-back must be given to Molly’s Fund Fighting Lupus. **All resources provided by Molly’s Fund are for informational purposes only and should be used as a guide or for supplemental information, not to replace the advice of a medical professional. The personal views do not necessarily encompass the views of the organization, but the information has been vetted as a relevant resource. We encourage you to be your strongest advocate and always contact your medical provider with any specific questions or concerns.

Article by : Kelli Roseta

Kelli Roseta is the Client Services Coordinator for Molly’s Fund Fighting Lupus and facilitates the patient and caregiver support groups. She is also a 26-year lupus survivor. Connect with Kelli at [email protected].