Benlysta: Limited Efficacy for Lupus?

an IV Drip

Benlysta is a new lupus treatment being made by Human Genome Sciences along with GlaxoSmithKline.  It is a fully human monoclonal antibody that targets the B-lymphocyte stimulator – BLYS for short – and has shown some efficacy in trials to date.

Our analysis, however, is that the results are lackluster and, unfortunately, likely to mean not so great efficacy in a clinical setting.

Let’s start at the beginning.

Systemic lupus erythematosus is an autoimmune connective tissue disorder where the body attacks itself.  It has strange and unpredictable symptoms and has a chronic, relapsing nature which makes treatment a challenge.

Up to 1.5 million Americans have some form of lupus, but the amount with serious symptoms is probably not that high.

The current treatments for lupus are limited and not so great.  They are commonly used off-label and can cause side effects over use.  For several decades, due to the complex nature of the condition, there has been no new treatment for lupus.

Benlysta is part of a growing trend of using monoclonal antibodies to treat disease.  Antibodies are a lot like heat-seeking missiles generated by your body.  They are Y shaped and have specific targets that, once they find, they bind to.

Benlysta targets B-lymphocytes which play a role in generating immune responses.  Theoretically this should provide significant clinical benefit.  Results have not been so great.

One of the first major studies into Benlysta showed no superiority over placebo.  Instead of dropping the project, the company looked at the study and changed its design to improve how their treatment works.  They developed an individual responder index to measure improvement, removed participants who were non-seropositive and changed some of the time related measures.

The next two Phase III trials had better results.  One, the BLISS-52, had 865 participants and 51.4% response rate on 1mg/kg dose and a much better 57.6% response to a 10mg/kg dose.  And the BLISS-76 of 819 patients had 40.6% response to the lower and 43.2% response to the higher dose.

The bad news?  In both trials, the response rate was not that much better than placebo – 46.3% responded to placebo in the first, and 33.8% in the second study.  That’s about a 10% difference in efficacy from placebo to treatment.

We also noticed that the treatment did not have any difference in steroid reductions compared to placebo.

These data indicate that Benlysta may not be the most effective treatment while likely being somewhat better than placbeo.


1) Re-evaluation of biologic therapies in systemic lupus erythematosus
2) Human Genome Sciences trial data wow lupus community

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Pharmaceutical analyst who loves blogging about health and medical issues. Has written more than 150 articles and a book on attention deficit disorder. Correctly predicted delayed approval of Bydureon, approval of Provenge by FDA, and the non-approval of Acthar on June 11.

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  1. Please furnish more information on how to join a medical research group for the use of Benlysta. Thanks

  2. Please furnish more information on how to join a medical research group for the use of Benlysta. Thanks

  3. After my first infusion of Benylsta I had flu like symptoms for about 3 days. Two weeks later I had my second. That time I had flu like symptoms for 4 or 5 days. By the time my fifth infusion came around I had to report to the infusion center that I was unable to do the infusion because I never recovered from the last infusion. I was bed ridden, extreme fatigued, could not eat, extreme depression, muscle weakness, Parkinson’s like tremors, confusion, vertigo, extreme pain and unable to control total body pain, dry eyes and lesions around my eyes, extreme and uncontrollable joint pain all over body.

    In my opinion the Benlysta made me worse than before I started. I read that in the UK the medical community refused to use Benlysta because they felt there wasn’t enough data proving its long term good or bad effects and that costs were prohibitive. If I am permanently impaired and disabled even more than what I am now, then the pharmaceutical company has a huge problem. I feel that some one some where was pushed into approving this drug for Lupus patients because there has been no approved drug for SLE for the last 50 years. Therefore awareness, a cure and pharmaceuticals for Lupus needs to increase.

    Im sorry my experience is bad but it needs to be said for someone who may NOT benefit from this frug and in fact get worse if they take it

  4. I signed on for long term use but only did it once. The side effects were so awful I thought i would die. I still have one lasting side effect a long time later that my doc refuses to consider as related to the drug.

    since the first report of major side effects less than one hour into infusion my doc’s staff pushed hard for me to say I had the flu instead. When I needed a script for the side effects they didn’t want to give me any because it would mean a side effect needed to be reported. When I wanted to go to the Emergency room they tried to talked me out of it. When I asked that they explain the new drug to the ER staff if I passed out they said they would only say I had the flu.

    They did everything they could to make me say all side effects were really the flu. They even tried to guilt trip me about how I would be holding up future help for other lupus people if my own severe side effects were reported.

    I had to go against doc orders to report my side effects. I only used the drug once and I may never be the same. I am now more disabled than I have ever been after 30 years of lupus. My doc staff remains angry that I wanted to report my symptoms. Loyalty is being quiet. Honest is being  a bad patient.

    I am now under open pressure to find another doc because I will not say my infusion symptoms were the flu.

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