The Latest News in Rheumatology
1/17/2003
Gene Links Found for Osteoporosis and Psoriatic Arthritis
Remicade (Infliximab) Granted Priority Review by FDA
for Use in Maintaining Fistula Closure in Patients With Fistulizing Crohn's
Disease
U.S. Drug Approval May Take Longer in 2003
Reykjavik, Iceland -- The discovery of a gene involved in osteoporosis
and a gene involved in psoriatic arthritis has been announced by an Icelandic
genetics company, deCODE. They based their research on the unique Icelandic
population, whose genetic makeup has not changed much from the time of the
Vikings, so these findings may not apply to other populations of the world.
The researchers plan to use this discovering in creating a DNA-based
diagnostic test, which they hope will enable doctors to determine early on
whether their patients are predisposed to osteoporosis. If they are predisposed,
the doctors can then help these patients adopt preventive measures that may significantly
reduce their chance of ever developing osteoporosis.
Results: deCode collaborated with doctors from the National University
Hospital in Reykjavik to identify 178 patients diagnosed with psoriatic
arthritis. Overall, more than 1000 individuals (both people with osteoporosis
and unaffected relatives) in 139 families took part in the study.
Besides finding the first genetic factor on a specific chromosome for
psoriatic arthritis, the scientists believe the study's results may have even
more far-reaching implications. The gene discovered for psoriatic arthritis
overlaps with a significant gene previously identified in osteoarthritis. deCode
suggests that this gene may influence the susceptibility of the joints in
general, interacting with other genetic or environmental factors that determine
the particular type of arthritis that develops.
Malvern, PA -- Centocor, Inc. announced that Remicade® (infliximab)
has been designated for priority review by the U.S. Food and Drug Administration
(FDA) for use in maintaining fistula closure in patients with fistulizing
Crohn's disease (CD). Up to 30% of the estimated half-million Americans with CD
suffer from fistulas, which are openings that burrow through the bowel wall into
nearby organs, or through the surface of the skin.
The FDA grants priority review status to products that are considered to be a
potential significant therapeutic advance over existing therapies.
Centocor submitted data to the FDA from a 54-week trial involving 306
patients with fistulizing CD at 45 sites in North America, Europe and Israel.
The objective of the study was to determine the safety and efficacy of Remicade®
in maintaining fistula closure when administered every eight weeks.
Remicade is the first and only biologic approved to reduce signs and symptoms
and induce and maintain clinical remission in patients with moderate to severe,
active Crohn's disease who have not responded to conventional therapy. The
medicine is also indicated as a short-term treatment for reducing the number of
draining enterocutaneous fistulas in patients with fistulizing Crohn's disease.
(Reuters) -- According to a recent report, it is anticipated that it
may take longer in 2003 for drug manufacturers to get approval to market new
medications because the U.S. Food and Drug Administration (FDA) is "hard
pressed" to met the organization's growling list of demands.
The Tufts Center for the Study of Drug Development (affiliated with Boston's
Tufts University) compiled this "Outlook 2003" report on
pharmaceutical issues. They claim that drug approval times have dropped 25%
since 1992, but that time may lengthen as drug companies vie for the attention
from the FDA.
Dr. Kenneth Kaiten, director of the Tufts Center, says: "In addition to
meeting demands for faster drug application reviews and providing greater
oversight of post-approval safety data, the FDA will provide closer scrutiny to
the ethical conduct of clinical trials." Meanwhile, growing economic
pressures and high research and development costs will force drug makers to
improve the efficiency of the drug development process.