Abbott Park, Illinois (ots/PRNewswire) -
- First expansion into new disease for rheumatoid arthritis drug
Abbott (NYSE: ABT) announced it has simultaneously submitted a
Marketing Authorization Application (MAA) to the European Medicines
Agency (EMEA) and a supplemental Biologics License Application (sBLA)
with the U.S. Food and Drug Administration (FDA) seeking approval to
market HUMIRA(R) (adalimumab) for psoriatic arthritis, an autoimmune
disorder that combines symptoms of psoriasis, such as dry, scaly skin
with arthritis symptoms, including joint pain and inflammation.
The filings are based on two placebo-controlled studies, including
data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial
(ADEPT), a Phase III clinical trial showing patients on HUMIRA
achieved significant improvement in both arthritic and psoriatic
signs and symptoms. Results from the ADEPT trial were recently
reported at the American College of Rheumatology congress in San
Antonio, Texas, in October.
"HUMIRA has been an effective treatment for people with rheumatoid
arthritis and our research shows great promise for treating psoriatic
arthritis and other inflammatory autoimmune conditions," said
Alejandro Aruffo, Ph.D., president, Abbott Bioresearch Center and
Immunoscience Development Center, Abbott. "This is encouraging news
for the millions of people afflicted with such diseases worldwide.
Abbott will continue to research the potential of HUMIRA and other
compounds as part of our commitment to use scientific innovation to
address major unmet medical needs."
HUMIRA is currently approved by the EMEA and the FDA for the
treatment of moderate to severe rheumatoid arthritis (RA) in adult
patients when the response to disease modifying anti-rheumatic drugs
(DMARDs), including methotrexate, has been inadequate.
"This news is encouraging for psoriatic arthritis patients and for
the dermatologists and rheumatologists who have limited therapeutic
options for treating this difficult disease," said Philip Mease,
M.D., lead study investigator, Swedish Medical Center and University
of Washington School of Medicine, Seattle. "The HUMIRA data shows
patients experienced significant relief from joint symptoms along
with a marked improvement in skin symptoms. For those with
significant psoriasis, about seven out of 10 patients achieved clear
or almost clear skin."
About the ADEPT Trial
The placebo-controlled, double-blind study assessed the efficacy
and tolerability of HUMIRA in 313 adults with active psoriatic
arthritis (defined as three or more swollen joints and three or more
tender joints) who had an inadequate response to therapy with
nonsteroidal anti-inflammatory drugs (NSAIDs). Patients received
placebo or 40 mg of HUMIRA administered subcutaneously every other
week, the same dose as the RA indication.
The study found that patients' psoriatic arthritis skin symptoms
showed a significant response to HUMIRA. Of the 69 patients with
greater than three percent of body surface involvement who were
treated with HUMIRA, 42 percent achieved a PASI 90 response at 24
weeks, which reflects at least a 90 percent improvement in psoriasis
symptoms assessed by the Psoriasis Area and Severity Index (PASI).
Nearly one-third of patients achieved a PASI 90 by week 12, which was
maintained through the study.
Patients' arthritic symptoms exhibited a rapid response to HUMIRA,
with nearly 60 percent of patients achieving ACR20 at week 12, one of
the study's primary endpoints, and sustaining response through week
24. American College of Rheumatology (ACR) scores measure the
percentage of improvement in tender and swollen joint count and other
clinical measures. At the 24-week follow-up, nearly one-fourth of
these patients achieved ACR70, which means patients had a 70 percent
improvement in arthritis signs and symptoms.
The rates of adverse events and serious adverse events in the
study were comparable between HUMIRA and placebo. Among patients
taking HUMIRA, the most common adverse events (those affecting at
least five percent of patients) were upper respiratory infection,
nasopharyngitis, injection site reaction, headache and hypertension.
The safety profile of HUMIRA in the psoriatic arthritis population
was similar to that observed with HUMIRA in the rheumatoid arthritis
About Psoriatic Arthritis
Psoriatic arthritis is an autoimmune disorder that combines
symptoms of psoriasis, such as dry, scaly skin and patches of red,
raised skin known as plaques, with arthritis symptoms including joint
pain and inflammation. Common symptoms of psoriatic arthritis include
varying degrees of psoriasis activity along with stiffness, pain,
swelling and tenderness of the joints that can lead to a reduced
range of motion and potential severe joint destruction.
Left untreated, psoriatic arthritis can be a progressively
disabling disease. The arthritic manifestations often include
debilitating disease of the hands and feet, as seen in rheumatoid
arthritis; as well as painful inflammation of the tendon insertions
and arthritis of the spine. Psoriatic arthritis is most often found
in patients who suffer from psoriasis, a chronic skin disease that
affects nearly three percent of the world's population. It is
estimated that up to 30 percent of people with psoriasis also develop
Like rheumatoid arthritis, psoriatic arthritis is an autoimmune
disorder in which a human protein, tumor necrosis factor-alpha
(TNF-alpha), has been suggested to play a role in disease
development. HUMIRA, which is a fully human monoclonal antibody that
resembles antibodies normally found in the body, works by
specifically blocking TNF-alpha.
Important Safety Information
Common adverse events ( > 1/100 and < / = 1/10) at least possibly
causally related to HUMIRA include headache, dizziness, respiratory
tract and urinary tract infection, nausea, diarrhea, sore throat,
herpes simplex, abdominal pain, rash, pruritis and anemia. Injection
site pain was reported by >1/10 of patients.
Patients must be monitored closely for infections, including
tuberculosis (TB), before, during and after treatment with HUMIRA.
Treatment should not be initiated in patients with active infections
until infections are controlled. Patients who develop new infections
while using HUMIRA should be monitored closely. HUMIRA should not be
used by patients with active TB or other severe infections such as
sepsis and opportunistic infections. HUMIRA should be discontinued if
a patient develops a new serious infection until infections are
controlled. Physicians should exercise caution when considering use
of HUMIRA in patients with a history of recurring infection or with
underlying conditions that may predispose patients to infections.
TNF-antagonists, including HUMIRA, have been associated in rare
cases with exacerbation of clinical symptoms and/or radiographic
evidence of demyelinating disease. Prescribers should exercise
caution in considering the use of HUMIRA in patients with
pre-existing or recent-onset central nervous system demyelinating
HUMIRA should be used with caution in patients with mild heart
failure, and is contraindicated in patients with moderate or severe
heart failure. HUMIRA must be discontinued in patients who develop
new or worsening symptoms of congestive heart failure.
HUMIRA is the only fully human monoclonal antibody approved by the
FDA and EMEA for reducing the signs and symptoms, inhibiting the
progression of structural damage and improving physical function in
adults with moderately to severely active RA who have had
insufficient response to one or more DMARDs. HUMIRA can be used alone
or in combination with methotrexate or other DMARDs. HUMIRA offers
convenient every-other-week dosing by subcutaneous injection (shot
beneath the skin) via a specially designed, pre-filled syringe.
Clinical trials are currently underway evaluating the potential of
HUMIRA in other autoimmune diseases, including juvenile rheumatoid
arthritis (JRA), psoriasis, psoriatic arthritis, Crohn's disease and
Abbott is a global, broad-based health care company devoted to the
discovery, development, manufacture and marketing of pharmaceuticals
and medical products, including nutritionals, devices and
diagnostics. The company employs more than 55,000 people and markets
its products in more than 130 countries.
Abbott's news releases and other information are available on the
company's Web site at http://www.abbott.com .
Web site: http://www.abbott.com
ots Originaltext: Abbott Laboratories
Im Internet recherchierbar: http://www.newsaktuell.ch
International Media, Rand Walton, +1-847-938-8848, U.S. Media, Jim
Bozikis, +1-847-937-6844, or Financial Community, Larry Peepo,
+1-847-935-6722, all of Abbott