Should Belimumab Have Been Approved?

Stephen Paget, MD

Disclosures

March 24, 2011

In This Article

Question

Do you think belimumab should have been approved? Why or why not?

Response from Stephen Paget, MD
Professor of Medicine, Weill Cornell Medical College; Physician-in-Chief, Center for Rheumatology, Hospital for Special Surgery, New York, NY

In my opinion, belimumab was approved for the following reasons:

  1. The investigators employed innovative outcome assessment tools not previously employed in other biologic studies allowing for marginally positive, but statistically significant, results;

  2. No drug has been approved for the treatment of lupus in 50 years and thus there is a groundswell of support for this drug, even though the results are, overall, moderate;

  3. A major determinant of patient outcomes relates to the huge cumulative doses of steroids in which these patients are bathed and this drug seems to have a steroid-sparing effect, which could be hugely important regarding steroid-related side effects that have a profoundly negative impact on quality and quantity of life;

  4. The drugs we are now using have been well defined as being overly toxic and not always net effective, particularly steroids; and

  5. The drug's side effects are acceptable, especially when compared with the toxicity of the current medications we use regularly.

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