Should Belimumab Have Been Approved?

Stephen Paget, MD


March 24, 2011

In This Article

When Not to Use Belimumab

So what does this drug add to the current array of treatments in terms of symptom control or adverse events avoided?

As noted above, the drug has the ability to spare steroids, which means that lupus is controlled by belimumab sufficiently so that the steroids that previously were needed to control inflammation can be tapered. Clearly, outcomes today on our current medications vary a great deal but are in no way perfect, and thus a new effective drug will find its place in the lupus armamentarium.

How would you envision this drug being used clinically, given its relatively modest efficacy and likely high cost? For example, for which patients would belimumab be most appropriate and which should stay with current standard treatments?

Lupus patients who will currently not be treated with belimumab will be:

  • The 20%-30% of lupus patients who have mild disease, with arthritis, pleurisy, low grade fever, fatigue, hair loss, and skin rash. Mild lupus is reasonably well controlled with nonsteroidal anti-inflammatory drugs, short courses of steroids, and antimalarial drugs. The likely cost and side effect profile of this drug will probably limit the use of this drug in patients with mild disease.

  • The 20%-30% who have severe, visceral, and life-threatening disease.

Perhaps in the future this will change, once we become more comfortable with the drug or new studies are published that reveal that it is effective and safe in patients with mild or severe disease.


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