Local trials helped in FDA approval of lupus drug
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Amy Clawson was diagnosed with lupus six years ago.
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Amy Clawson was unable to do much of anything with her hands. "My fingertips had ulcerations," she said. "They were very sore."
On top of that, Mrs. Clawson, 38, of Derry, was tired "all the time. I didn't have any energy." Her appetite was poor and she lost weight. Sometimes she had joint pain in her legs.
When she was 32, the cause of her problems was diagnosed: She had lupus, a chronic and potentially fatal disease with no known cure.
With lupus, something goes wrong with the immune system, which normally provides protection against foreign bodies such as bacteria and viruses; it instead attacks healthy tissue. The results can be inflammation, pain and damage in any part of the body. Symptoms worsen during periods called "flares."
The Lupus Foundation of America estimates that at least 1.5 million Americans have the disease, of which there are four types. Mrs. Clawson has the most common type: systemic lupus erythematosus.
Women are more often affected than men, and African-American women have been reported to be three times more likely to have lupus than white women.
Standard treatments include immunosuppressants, antimalarial medicines and corticosteroids. Mrs. Clawson said she tried them all.
Finally, Mrs. Clawson's rheumatologist, Fotios Koumpouras, then at the University of Pittsburgh but now medical director of the Lupus Center of Excellence in the West Penn Allegheny Health System, asked her if she'd like to participate in a medical study.
She said OK.
He entered her in a trial in which he was participating for patients with her variety of lupus. Conducted and paid for by Human Genome Services with development partner GlaxoSmithKline, it was looking at a new drug called belimumab, used in conjunction with the standard therapy. Dr. Koumpouras' Pitt colleague Susan Manzi, now director of the WPAHS lupus center, helped to design the trials.
The two drug companies provided financial support for the costs of the part of the trial conducted at Pitt, and Dr. Manzi was a paid consultant as a member of a medical advisory board.
First Published March 21, 2011 12:00 am
