Physical Function
Patients taking HUMIRA showed significant improvement in physical
function as assessed by the Health Assessment Questionnaire Disability
Index (HAQ) score and the Short Form-36 Health Status Survey (SF-36).
HAQ scores assess a patient's ability to perform daily activities
such as getting dressed, walking and climbing stairs. Statistically
significant improvements in HAQ were achieved by patients in the
HUMIRA group compared to placebo at week 24 (p<0.001). Patients
taking HUMIRA also showed statistically significant improvement
compared to placebo in the SF-36 Physical Component Score (p<0.001).
The SF-36 is a broad questionnaire that examines the physical and
mental impact on patients. Improvements in physical function were
maintained through week 84.
Joint and Skin Symptoms
The October 2005 FDA approval of HUMIRA for active arthritis in
psoriatic arthritis was based on two studies including ADEPT 24-week
results measuring joint symptoms with American College of Rheumatology
(ACR) scores and skin disease symptoms with the Psoriasis Area Severity
Index (PASI). Patients' arthritic symptoms responded to HUMIRA,
with nearly 60 percent of patients achieving ACR20 through week
24. An ACR20 score indicates a 20 percent or greater improvement
in tender and swollen joint counts and several other clinical measures.
The primary endpoint was ACR20 at week 12 in the ADEPT trial.
ADEPT also studied the ability of HUMIRA to improve the psoriatic
skin symptoms associated with PsA. Sixty-nine patients in the HUMIRA
group had skin lesions on greater than 3 percent of their body skin
surface at the onset of the trial. (The palm of an adult hand represents
approximately 1 percent.) Of these patients, approximately three
out of five achieved 75 percent improvement, and more than two out
of five achieved 90 percent improvement at 24 weeks (called PASI
75 or 90 responses, respectively in the study; p<0.001).
Joint results were maintained for patients in the HUMIRA group through
week 48. Patients in the placebo group achieved similar results
after receiving HUMIRA from week 24 through week 48. Skin results
were also maintained in the HUMIRA group through week 48, when nearly
three out of five patients achieved PASI 75 skin clearance and nearly
one out of two patients achieved PASI 90 skin clearance response
at week 48. Patients in the placebo group achieved similar results
after receiving HUMIRA in the 24-week, open-label extension.
"Psoriatic arthritis is a multifaceted disease in which patients
can experience joint and skin symptoms that may lead to disability
and decreased quality of life," said Eugene Sun, M.D., vice president,
Global Pharmaceutical Clinical Development, Abbott. "HUMIRA effectively
treats multiple aspects of the disease, making it a promising comprehensive
treatment for these patients."
About Psoriatic Arthritis
Psoriatic arthritis combines skin symptoms, such as dry, scaly skin
and painful 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 skin involvement
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 (the part
of the tendon that attaches to the bone) and arthritis of the spine.
Psoriatic arthritis is often found in patients who suffer from psoriasis,
a chronic skin disease that affects nearly 3 percent of the world's
population. It is estimated that up to 30 percent of people with
psoriasis also develop psoriatic arthritis.
Like RA, 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
Serious infections, sepsis, tuberculosis (TB) and rare cases of
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. 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.
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. 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 four 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.
The most frequent adverse events seen in the placebo-controlled
clinical trials in 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 and psoriatic
arthritis, the safety profile for patients treated with HUMIRA was
similar to the safety profile seen in patients with rheumatoid arthritis.
About HUMIRA
HUMIRA is the only fully human monoclonal antibody approved for
the treatment of rheumatoid arthritis (RA), psoriatic arthritis
(PsA), and ankylosing spondylitis (AS) in the U.S. and Europe. HUMIRA
resembles antibodies normally found in the body. It works by blocking
tumor necrosis factor alpha (TNF-α), a protein that plays
a central role in the inflammatory responses of autoimmune diseases.
To date, HUMIRA has been approved in 67 countries and more than
160,000 people worldwide are currently being treated with HUMIRA.
Clinical trials are currently under way evaluating the potential
of HUMIRA in other autoimmune diseases.
In the U.S., HUMIRA is approved by the FDA for reducing signs and
symptoms, inducing major clinical response, inhibiting the progression
of joint 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 was also approved on July 28, 2006 for reducing
signs and symptoms in patients with active AS.
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, Massachusetts, United States, is a
world-class discovery and basic research facility committed to finding
new treatments for autoimmune diseases.
More information about HUMIRA, including full prescribing information,
is available on the Web site http://www.HUMIRA.com or in the
United States by calling Abbott Medical Information at 1-800-633-9110.
About Abbott
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 65,000 people and markets its products in more
than 130 countries.
Abbott
http://www.abbott.com/
New Evidence Shows MabThera Inhibits Joint Damage In Patients
With Rheumatoid Arthritis
Main Category: Arthritis News
Article Date: 25 Jun 2006 - 6:00 PST
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New data presented at the EULAR meeting (European League Against
Rheumatism) show for the first time that MabThera (rituximab), a
unique B cell targeted therapy, is able to significantly inhibit
structural damage of joints caused by rheumatoid arthritis (RA).
The study was conducted in patients who had an inadequate response
to one or more TNF inhibitors and they received either MabThera
plus methotrexate (MTX) or MTX alone. X-ray evidence at 56 weeks
showed that the progression of bone erosions and progression of
narrowing of joint spaces in patients in the MabThera group were
reduced by more than 50 % compared to patients receiving MTX alone
(erosion scores of 0.59 and 1.32 respectively; joint space narrowing
scores of 0.41 and 0.99 respectively).
Damage to the structure of the joints ultimately causes destruction
of the joints and contributes to joint deformity and loss of mobility.
Patients' ability to work and perform every day tasks such as getting
dressed, walking and eating can be severely hampered.
Presenting the results, Professor Keystone, Rheumatology Department
at the University of Toronto, Canada, said: "This is the first
evidence demonstrating that MabThera can inhibit structural joint
damage in patients with an inadequate response to one or more TNF
inhibitors. Preventing structural damage is a critical outcome in
treating rheumatoid arthritis. These X-ray data confirm MabThera
as an effective and innovative therapy for patients with rheumatoid
arthritis and highlight the value of targeting B cells."
Repeat treatment courses
Additional new data presented at EULAR demonstrate that repeat courses
of MabThera in RA patients, 6 to 12 months after the initial course,
provide continued improvement of symptoms across all clinical measures.
Each treatment course consists of two infusions of 1000mg given
two weeks apart. The challenging goal of treatment in RA is remission
and, following a second course of MabThera in patients with an inadequate
response to one or more TNF inhibitors, the number of patients achieving
remission doubled from 6 % following an initial course to 13 % following
a second course. A similar trend was seen for those achieving the
hard-to-reach goal of a 70 % improvement in symptoms (ACR70), with
responses increasing from 12 % following an initial course to 21
% following a second course.
Patient perspectives
Importantly, data presented at EULAR show improvements in clinical
scores are reflected in patient reported outcomes.
"While it is important to a physician to address a disease
from a clinical perspective, what matters most to the patient is
whether they are able to function normally and how well they feel.
For example, the impact of fatigue is often underestimated, but
this is something which really impacts patients' lives. MabThera
has demonstrated continuous improvements in physical and mental
health aspects with repeated courses of therapy", said Professor
Tak, Director, Division of Clinical Immunology and Rheumatology
at the Academic Medical Centre/University of Amsterdam, The Netherlands.
###
Approval Status
On 2 June 2006 MabThera received a recommendation for approval from
the Committee for Medicinal Products for Human Use (CHMP) for the
treatment of rheumatoid arthritis (RA) in Europe. MabThera, in combination
with methotrexate, has been recommended for the treatment of adult
patients with severe active rheumatoid arthritis who have had an
inadequate response or intolerance to other disease-modifying anti-rheumatic
drugs (DMARDs). On 28 February 2006, after priority review, Genentech
and Biogen Idec received US approval for Rituxan (rituximab in the
US) for the treatment of adult patients with moderately to severely
active RA in combination with methotrexate for reducing signs and
symptoms in those RA patients who have had an inadequate response
to one or more tumour necrosis factor (TNF) therapies.
About the REFLEX study
The REFLEX study (Randomised Evaluation oF Long-term Efficacy of
MabThera in RA) is a multi-centre, randomized, double-blind, placebo-controlled
Phase III study. In this trial, patients who received a single course
of only two infusions of MabThera with a stable dose of methotrexate
(MTX) displayed a statistically significant improvement in symptoms
measured at 24 weeks, compared to those receiving placebo and MTX.
Patients receiving additional courses did so between 6 and 12 months
after the initial course. Consistent with previous findings, analysis
of the REFLEX 56-week data did not reveal any unexpected safety
signals. The companies continue to monitor the long-term safety
of rituximab in all clinical trials.
A further phase III development programme for MabThera therapy
in patients with rheumatoid arthritis who have had an inadequate
response to disease modifying anti-rheumatic drugs (DMARDs) is ongoing.
Long term safety and repeated courses
Further new data of a pooled analysis presented at EULAR confirmed
the safety profile of rituximab identified in the original randomised
clinical trials. The analysis included all RA patients treated with
MabThera during clinical development which amounted to over 1,600
patient years with some patients being followed for over 3 years,
many of whom had received multiple courses of treatment. This analysis
did not reveal any unexpected safety signals.
About MabThera in rheumatoid arthritis
MabThera selectively targets a subset of B cells that express CD20,
leaving stem, pro-B and plasma cells unaffected. This subset of
B cells plays a key role in the autoimmune process of RA and MabThera
aims to interrupt this process by inhibiting a series of reactions
inflaming the synovia and leading to cartilage loss and bone erosion
that is characteristic of the disease. More than 1,000 patients
with RA have been treated with MabThera in clinical trials to date.
A comprehensive Phase III clinical development programme is also
currently underway to further investigate the potential clinical
benefit of MabThera in earlier RA.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's
leading research-focused healthcare groups in the fields of pharmaceuticals
and diagnostics. As a supplier of innovative products and services
for the early detection, prevention, diagnosis and treatment of
disease, the Group contributes on a broad range of fronts to improving
people's health and quality of life. Roche is a world leader in
diagnostics, the leading supplier of medicines for cancer and transplantation
and a market leader in virology. In 2005, sales by the Pharmaceuticals
Division totalled 27.3 billion Swiss francs, and the Diagnostics
Division posted sales of 8.2 billion Swiss francs. Roche employs
roughly 70,000 people in 150 countries and has R&D agreements
and strategic alliances with numerous partners, including majority
ownership interests in Genentech and Chugai. Additional information
about the Roche Group is available on the Internet (http://www.roche.com/).
All trademarks used or mentioned in this release are legally protected.
For further information:
-About EULAR: http://www.eular.org/
-British Society for Rheumatology: http://www.rheumatology.org.uk/
-American College of Rheumatology: http://www.rheumatology.org/
-About Genentech: http://www.gene.com/
-About BiogenIdec: http://www.biogenidec.com/
Media Relations Contacts: - Baschi D?> - Alexander Klauser
- Daniel Piller (Head Roche Group Media Office)
- Katja Prowald (Head R&D Communications)
- Martina Rupp
Contact: Basel Media Office
European League Against Rheumatism
What is arthritis?
Main Category: Arthritis News
Article Date: 24 Apr 2004 - 0:00 PST
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Arthritis affects millions of people around the world. It can affect
men, women and children of all ages. Arthritis means "inflammation
of a joint". In spite of its name, however, some forms of arthritis
do not involve inflammation. Arthritis is a broad term which is
used to refer to more than 100 conditions that can cause pain in
the body's joints.
Some forms of arthritis cause mild symptoms which can be controlled
with proper care and treatment. Others are very serious and if left
untreated may lead to severe disability.
Each type of arthritis has a unique treatment program. One factor
is common to all types of arthritis - the earlier a diagnosis is
made, the sooner treatment can be started and treatment can help
to avoid disability and permanent damage. The five most common types
of arthritis in the world are:
-- OSTEOARTHRITIS {OSS/tee/o/are/THRY/tis} is also known as "degenerative
joint disease". Osteoarthritis develops later on in life and
usually affects only a few joints. It is generally believed to be
caused by the wear and tear that joints are subjected to over time
although some chemical and genetic factors may play a part.
-- RHEUMATOID ARTHRITIS causes inflammation and can affect the
whole body. Rheumatoid arthritis is an autoimmune condition. This
means that the body's own immune system has begun to attack its
own tissues - in this case the tissues in the joints. This type
of immune system attack over time can lead to tissue and joint damage.
The most common joints affected are those of the hands, wrists,
arms and feet. It is more common in women. It generally occurs in
a much younger age group than other forms of arthritis and can occur
in children.
The symptoms of rheumatoid arthritis are pain, stiffness and deformity.
In most cases the pain and stiffness can be relieved and the deformity
prevented with a combination of medication, rest, exercise and joint
protection.
-- GOUT is a type of arthritis resulting from a disorder of the
body's metabolism (metabolism refers to the chemical processes in
the body). It occurs because of a build up of uric acid in the body.
The symptoms of gout are pain, redness and swelling in a joint.
It commonly affects only one joint at a time - most often the joint
at the base of the big toe. It may affect other parts of the foot,
ankles, knees and hands as well. Men are 10 times more likely to
suffer from gout than women.
Many people never have more than one attack of gout and there is
minimal, or no, damage to the joint as a result. After repeated
attacks, however, joint damage can occur. In the treatment of gout,
medications are used to reduce the inflammation and to lower the
level of uric acid in the body.
Since high levels of a substance called purine can increase uric
acid levels, people prone to attacks of gout may wish to reduce
their intake of the following foods that are high in purine: organ
meats, legumes, and poultry. Drinking alcohol may also trigger an
attack of gout in some people.
-- Another condition called pseudo-gout {SUE/doe/gowt} is similar
to gout but involves calcium crystals instead of uric acid crystals.
Normally treatment for both conditions involves anti-inflammatory
medication.
-- ANKYLOSING SPONDYLITIS {ANK/ee/loe/sing spon/dih/LIE/tis} is
an inflammatory disease that affects the spine and the joints between
the spine and the pelvis. The cause is not clear at the present
time.
People most commonly begin to notice symptoms of ankylosing spondylitis
between 20 and 40 years of age. It is most common in males, but
can occur in both sexes. The symptoms of ankylosing spondylitis
are pain and stiffness in the lower back and hips especially after
resting.
Pain and stiffness may also occur in the chest, knees and ankles.
Interestingly, the pain and stiffness seem to improve with activity
and exercise.
As one gets older the inflammatory process involved in ankylosing
spondylitis tends to become less and the progression of the disease
slows or stops. If left untreated, however, the bones of the spine
and pelvis may begin grow together (fuse) causing permanent stiffening
and loss of mobility.
Treatment to prevent or reduce joint damage caused by anlylosing
spondylitis consists of anti-inflammatory medications to reduce
the inflammation and pain and gentle regular exercise to maintain
the mobility of joints.
You have an important role to play in the early diagnosis and treatment
of arthritis. Early treatment can mean less disability in the long
run. If you have symptoms of arthritis, report them to your doctor.
An examination, and sometimes x-rays and blood tests, will help
your doctor to decide if you have arthritis. A treatment program
can then be set up to reduce the pain and disability that arthritis
can cause.
This material is designed for information purposes only. It should
not be used in place of medical advice, instruction and/or treatment.
If you have specific questions, please consult your doctor or appropriate
health care professional.
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