Hope, Long on the Horizon,
Finally Arrives for Those with Lupus
Clinical Trial at Seligman Center Helps Bring New Drug to Market
Vianny Antigua thought she would never feel
normal again. Seven years ago, the 23-year-
old respiratory therapy student was diagnosed
with systemic lupus erythematosus, or lupus,
a devastating autoimmune disorder that
wreaks havoc on the immune system, causing
the body to attack its own healthy tissues
and organs, most commonly the skin, joints,
kidneys, heart, lungs, and brain. The result:
chronic fatigue, swollen joints, rashes, and
organ damage. “I was in constant pain,” she
recalls. “The swelling in my knees made it
difficult to bend down or walk for long periods
of time. The drugs they used to treat me had
horrible side effects. I felt hopeless.”
of medicine. “We have finally broken down
the wall to getting a drug approved for lupus.
Patients and their families have been eagerly
awaiting this moment for decades.” Until
now, patients have relied on corticosteroids,
antimalarial drugs, and drugs prescribed off-label (used to treat a condition for which they
have not been officially approved), such as
immunosuppressants. But the risk of severe side
effects, such as acne, weight gain, bone loss,
diabetes, and infection, loom large. By targeting
the activity of a protein in the body called B
lymphocyte stimulator, belimumab seems to not
only lessen disease activity, but also obviate the
need for high doses of steroids.
MD, professor of medicine. Dr. Buyon helped
design the instrument that allowed researchers
to evaluate lupus activity in a late-stage Phase
III clinical trial, while Dr. Askanase identified
and evaluated eight participants for the study.
“N YU Langone had a highly instrumental role
in bringing this drug to market,” explains Dr.
Buyon. “We helped develop the gauge that
physicians used in the trial to evaluate disease
activity and response to therapy.” Dr. Askanase
and Dr. Buyon have both served as paid
consultants to Benlysta’s manufacturer.
For Antigua and the nearly 1.5 million
Americans who suffer from lupus—mostly
young women—hope has finally arrived.
Thanks in part to research conducted at the
Seligman Center for Advanced Therapeutics
at N YU Langone Medical Center’s Hospital
for Joint Diseases, the Food and Drug
Administration (FDA) recently approved
belimumab (sold under the trade name
Benlysta®). The first new medication designed
specifically to treat lupus in more than half a
century, it has been hailed as one of the first
drugs to emerge from the genomics revolution.
Antigua started taking belimumab, a
human monoclonal antibody administered
intravenously once a month (after two loading
doses), two years ago as part of a clinical
trial at the Seligman Center. Soon after, her
symptoms—crippling arthritis, disfiguring
skin rashes, and debilitating fatigue—began
to vanish, and she was able to cut back on her
other medications. “I can’t remember the last
time I felt this good or this happy,” Antigua
rejoices. “I have a lot of energy, and I’m not in
any pain.”
Lupus, a disease of unknown origin, has
been particularly daunting to treat because it
affects multiple organ systems. At least seven
potential therapeutic drugs have failed in
clinical trials. Typically, it takes at least a decade
for a new drug to reach the market. Researchers
have been working on belimumab for 15 years.
“This is an extraordinary achievement,”
notes Anca Askanase, MD, assistant professor
Among the N YU Langone researchers
who, together with Dr. Askanase, played an
integral role in the clinical trials is Jill Buyon,
“It is a rare opportunity that we’re able
to be a part of developing a drug that has the
potential to change people’s lives,” says Dr.
Buyon. “Patients are excited for the first time in
so long, and we are filled with pride.” Vianny
Antigua, for one, considers herself a new
woman. She is now able to attend school full-time, socialize, and avoid hospitalizations. “I
really am living a normal life,” she says, having
graduated in May. “Some days, I forget that I
even have lupus.”
Wes Bedrosian
