A study of
ankylosing spondylitis (AS) patients treated with Abbott’s HUMIRA(R) showed
a decrease in the rate of uveitis flares by approximately half compared to
patients treated with placebo. Ankylosing spondylitis is an inflammatory
disease of the spine, and may also be associated with other inflammatory
diseases of the skin, eyes, and intestines. Uveitis, or inflammation of the
eye, occurs in up to 40 percent of people with AS, and can lead to severe
and painful symptoms, including eye damage and blindness. These data were
presented today at the American College of Rheumatology Annual Scientific
Meeting in Boston.
The RHAPSODY (Review of safety and effectiveness witH Adalimumab in
Patients with active ankylosing SpOnDYlitis) trial was designed to examine
the effectiveness of HUMIRA in treating the signs and symptoms of AS in
patients with active disease despite previous standard treatment. The 1,250
patient trial also included a subset of patients (n=274) with uveitis.
Results of the trial suggested that the number of uveitis flares was
reduced in patients with active AS treated with HUMIRA.
In the prospective, multi-national, open-label trial, adult patients
with active AS who had insufficient responses to prior non-steroidal
anti-inflammatory drug (NSAID) therapy received open-label HUMIRA 40 mg
subcutaneously every other week for 12 weeks. Patients with symptomatic
uveitis at baseline and/or in the previous year received the same regimen
for a total of 20 weeks. Evaluations of treatment effects were measured at
weeks 2, 6, 12 and week 20, if applicable.
This analysis measured the number of acute flares during treatment with
HUMIRA both for all patients in the trial and for patients with pre-known
history of uveitis. The rate was calculated as flares per 100-patient-years
(100-PYs), which represent the number of flares that would occur in 100
patients observed or treated for one year. The rate of uveitis flares was
reduced by approximately half during treatment with HUMIRA compared with
the rate prior to the trial (15 flares/100-PY to 7.4 flares/100-PY in the
entire trial population, 68.4 flares/100-PY to 28.9 flares/100-PY in the
subset with a history of uveitis).
Overall, 27 adverse events of uveitis were reported for 25/1,250
patients. Two of the 25 patients experienced an attack of uveitis for the
first time. In both patients, the general AS disease activity was high at
time of the anterior uveitis episode.
“Uveitis is a fairly common and potentially serious complication of
ankylosing spondylitis,” said Martin Rudwaleit, M.D., of the Charite
University Hospital in Germany and lead author of the trial. “This study is
an example of the research needed to better understand this condition and
the impact it has on these patients.”
About RHAPSODY
RHAPSODY (Review of safety and effectiveness witH Adalimumab in
Patients with active ankylosing SpOnDYlitis) is a prospective,
multi-national, open-label trial designed to examine the effectiveness of
HUMIRA in treating the signs and symptoms of the disease in a large number
of patients (n=1,250) with active AS despite previous standard treatment,
including patients with uveitis (n=274), in real-life clinical practices.
About Uveitis
There are three different types of uveitis based on the part of the eye
involved, including anterior, posterior or intermediate. Acute anterior
uveitis occurs in up to 40 percent of patients with AS. Symptoms include
pain, light sensitivity, blurry vision or reduced vision; severe
complications may include high eye pressure, cataracts, or glaucoma, which
can lead to permanent loss of vision.
About Ankylosing Spondylitis
Ankylosing spondylitis (AS) is a type of arthritis that primarily
causes inflammation of the spine. Ankylosing means “stiff or rigid” and
spondylitis means “inflammation of the spine.” Advanced AS can lead to new
bone formation on the spine causing the spine to fuse in a fixed position.
Typically, the first symptoms of AS are gradual and can include frequent
pain and stiffness in the lower back and buttocks. In addition to back
pain, other symptoms can include inflammation of joints or tendons, weight
loss, fatigue, and eye inflammation (uveitis).
AS affects an estimated 129 out of 100,000 people in the United States
and commonly develops between the ages of 15 and 40. Men are three times
more likely than women to develop AS. Although the course and severity of
AS varies from person to person, some patients with progressive AS can
develop spinal deformities leading to significant disability.
The cause of AS is not known, though genetics may play a role: 90
percent of people with AS share a common genetic marker, but having this
genetic marker does not mean a person will develop the disease.
Important Safety Information
Serious infections, sepsis, tuberculosis (TB) and opportunistic
infections, including fatalities, have been reported with the use of
TNF-blocking agents, including HUMIRA. Many of these serious infections
have occurred in patients also taking other immunosuppressive agents that
in addition to their underlying disease could predispose them to
infections. Infections have also been reported in patients receiving HUMIRA
alone. Treatment with HUMIRA should not be initiated in patients with
active infections. TNF-blocking agents, including HUMIRA, have been
associated with reactivation of hepatitis B (HBV) in patients who are
chronic carriers of this virus. Some cases have been fatal. Patients at
risk for HBV infections should be evaluated for prior evidence of HBV
infections before initiating HUMIRA. The combination of HUMIRA and anakinra
is not recommended and patients using HUMIRA should not receive live
vaccines.
More cases of malignancies have been observed among patients receiving
TNF blockers, including HUMIRA, compared to control patients in clinical
trials. These malignancies, other than lymphoma and non-melanoma skin
cancer, were similar in type and number to what would be expected in the
general population. There was an approximately 3.5 fold higher rate of
lymphoma in combined controlled and uncontrolled open-label portions of
HUMIRA clinical trials. The potential role of TNF-blocking therapy in the
development of malignancies is not known. TNF-blocking agents, including
HUMIRA, have been associated in rare cases with demyelinating disease and
severe allergic reactions. Infrequent reports of serious blood disorders
have been reported with TNF-blocking agents.
Worsening congestive heart failure (CHF) has been observed with
TNF-blocking agents, including HUMIRA, and new onset CHF has been reported
with TNF-blocking agents. Treatment with HUMIRA may result in the formation
of autoantibodies and rarely, in development of a lupus-like syndrome.
The most frequent adverse events seen in the placebo-controlled
clinical trials in adults with rheumatoid arthritis (HUMIRA vs. placebo)
were injection site reactions (20 percent vs. 14 percent), upper
respiratory infection (17 percent vs. 13 percent), injection site pain (12
percent vs. 12 percent), headache (12 percent vs. 8 percent), rash (12
percent vs. 6 percent) and sinusitis (11 percent vs. 9 percent).
Discontinuations due to adverse events were 7 percent for HUMIRA and 4
percent for placebo. As with any treatment program, the benefits and risks
of HUMIRA should be carefully considered before initiating therapy.
In HUMIRA clinical trials for ankylosing spondylitis, psoriatic
arthritis and Crohn’s disease, the safety profile for adult patients
treated with HUMIRA was similar to the safety profile seen in adult
patients with rheumatoid arthritis.
About HUMIRA
HUMIRA is approved for the treatment of adults with rheumatoid
arthritis, psoriatic arthritis (PsA), ankylosing spondylitis (AS) and
Crohn’s disease in the United States and in Europe. HUMIRA resembles
antibodies normally found in the body. It works by blocking tumor necrosis
factor alpha (TNF-alpha), an inflammatory protein that, when produced in
excess, plays a key role in the inflammatory responses of autoimmune
diseases.
Earlier this year, HUMIRA received FDA approval of data in the Clinical
section of the label regarding the long-term maintenance of efficacy to 5
years with respect to clinical response, physical function and radiographic
response in patients with rheumatoid arthritis. To date, HUMIRA has been
approved in 67 countries and more than 190,000 people worldwide are
currently being treated with HUMIRA. Clinical trials are currently under
way evaluating the potential of HUMIRA in other immune-mediated diseases.
In the U.S., HUMIRA is approved by the FDA for reducing signs and
symptoms, inducing major clinical response, inhibiting the progression of
structural damage, and improving physical function in adult patients with
moderately to severely active RA. HUMIRA is indicated for reducing the
signs and symptoms of active arthritis, inhibiting the progression of
structural damage and improving physical function in patients with
psoriatic arthritis. HUMIRA can be used alone or in combination with
methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs).
HUMIRA is also approved for reducing signs and symptoms in patients with
active AS.
Earlier this year, HUMIRA was approved for reducing the signs and
symptoms and inducing and maintaining clinical remission in adults with
moderately to severely active Crohn’s disease who have had an inadequate
response to conventional therapy, and reducing the signs and symptoms and
inducing clinical remission in these patients if they have also lost
response to or are intolerant to infliximab.
Abbott’s Commitment to Immunology
Abbott is focused on the discovery and development of innovative
treatments for immunologic diseases. The Abbott Bioresearch Center, founded
in 1989 in Worcester, Mass., United States, is a world-class discovery and
basic research facility supporting research and development of biologic
treatments. Abbott Biotechnology Limited, which opened April 10, 2007, in
Barceloneta, Puerto Rico, is the main production facility for HUMIRA.
About Abbott
Abbott (NYSE: ABT) is a global, broad-based health care company devoted
to the discovery, development, manufacture and marketing of pharmaceuticals
and medical products, including nutritionals and devices. The company
employs 65,000 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 abbott.
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