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Tuesday 4th October, 2005
The FDA approved HUMIRA® (adalimumab) for reducing signs and symptoms of
active arthritis in patients with psoriatic arthritis.
Abbott Park, Illinois ? Abbott announced
that the U.S. Food & Drug Administration (FDA)
approved HUMIRA? (adalimumab) for reducing signs and
symptoms of active arthritis in patients with psoriatic
arthritis, a chronic disease that combines the symptoms of
arthritis, including joint pain and inflammation, with those
of psoriatic skin disease, such as dry, scaly skin.
Psoriatic arthritis (PsA) is a serious autoimmune disease and few
available treatment options address the potentially devastating
combination of symptoms affecting both the skin and joints.
Psoriatic arthritis is the first new disease indication for HUMIRA
beyond rheumatoid arthritis (RA) and is one of the five autoimmune
diseases Abbott is studying for HUMIRA therapy.
"The pain of psoriatic arthritis combined with the social stigma
of its visible symptoms places a huge burden on people living with
this disease," said Gail M. Zimmerman, president and chief executive
officer of the National Psoriasis Foundation. "The symptoms can be
debilitating and some patients experience diminished quality of life
that may leave them feeling depressed and socially isolated. The
HUMIRA approval brings another effective treatment option and hope
for patients with this potentially devastating disease."
HUMIRA in Psoriatic Arthritis
The HUMIRA approval is based on results of the Adalimumab
Effectiveness in Psoriatic Arthritis Trial (ADEPT), which is the
largest biologic trial in PsA. ADEPT studied 313 adult patients with
moderately to severely active PsA who had an inadequate response to
NSAID (non-steroidal anti-inflammatory drug) therapy. HUMIRA
patients experienced significantly greater improvement in both joint
and skin disease symptoms than placebo-treated patients at 24 weeks.
Improvements in both skin lesions and joint symptoms were seen as
early as two weeks after initiation of treatment and continued to
improve over time.
Patients' arthritic symptoms also responded to HUMIRA, with
nearly 60 percent of patients achieving ACR20 at week 12, one of the
study's primary endpoints, and with a sustained response through
week 24. ACR70, a more stringent response criterion, was achieved by
nearly 25 percent of patients treated with HUMIRA vs. 1 percent of
patients treated with placebo at week 24. American College of
Rheumatology (ACR) scores measure the percentage of improvement in
tender and swollen joint count and several other clinical measures.
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"Clinical improvement in arthritic symptoms that can lead to
disability as well as the pain and stiffness that keeps patients
from functioning normally was rapid and significant with HUMIRA,"
said rheumatologist Philip Mease, M.D., Swedish Medical Center and
University of Washington School of Medicine, Seattle, and lead
investigator of the ADEPT study.
Clinical trial data from ADEPT showed the ability of HUMIRA to
improve both the skin and joint symptoms associated with psoriatic
arthritis. Among the 69 patients in the trial who had skin lesions
involving greater than 3 percent body surface area (the palm of an
adult hand represents approximately 1 percent of the body?s skin
surface) who were treated with HUMIRA, three out of four achieved
PASI 50 (75 percent), three out of five achieved a PASI 75 (59
percent) and two out of five (42 percent) achieved a PASI 90
response at 24 weeks, which reflects at least 50, 75 or 90 percent
improvement in skin symptoms assessed by the Psoriasis Area and
Severity Index (PASI).
The skin symptoms of psoriatic arthritis can severely affect
patients' day-to-day lives," said dermatologist Kenneth Gordon,
M.D., incoming co-director of Dermatology, Evanston Northwestern
Healthcare. "The approval of HUMIRA gives patients access to a
medication that can significantly impact skin symptoms and allow
them to engage in everyday activities again, such as shaking hands
when closing a business deal or going to a public pool."
After taking HUMIRA, my skin improved for the first time in
years," said Annie Escalona, a native of Seattle and hiking
enthusiast. "My joint pain kept getting better and my skin was much
clearer. I can now wear a backpack, swim and enjoy activities I
would have never dreamed of doing just a few years ago."
The recommended dose of HUMIRA for psoriatic arthritis is 40 mg
every-other-week by subcutaneous injection (a shot beneath the
skin), the usual dose used for HUMIRA in the treatment of moderate
to severe RA.
The rates of adverse events and serious adverse events in the
ADEPT trial were comparable with other HUMIRA RA clinical trials.
Among patients taking HUMIRA, the most common adverse events (those
affecting at least 5 percent of patients) were upper respiratory
infection, nasopharyngitis, injection site reaction, headache and
hypertension. The safety profile of HUMIRA in the ADEPT clinical
trial was similar to that observed in the HUMIRA RA clinical trials.
Abbott simultaneously submitted applications with the FDA and the
European Medicines Agency seeking approval to market HUMIRA to treat
psoriatic arthritis and early moderate to severe RA in December
2004. Abbott also announced today FDA approval for HUMIRA for early
RA and received European approval for psoriatic arthritis and early
severe RA on August 8, 2005.