Should Belimumab Have Been Approved?

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.

Medscape Rheumatology © 2011  WebMD, LLC

Cite this: Should Belimumab Have Been Approved? - Medscape - Mar 24, 2011.