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Golimumab Phase 3 Data Show Significant Improvement In Physical Function In Patients With Rheumatoid Arthritis
Results from two Phase 3 studies
showed that patients receiving every four week subcutaneous injections of
golimumab (CNTO 148) 50 mg or 100 mg, an investigational therapy,
experienced significant improvements in physical function, health-related
quality of life (HRQOL) and fatigue. The data from the randomized,
double-blind, placebo- controlled studies in patients with active moderate
to severe rheumatoid arthritis (RA) were presented at the American College
of Rheumatology (ACR) Annual Scientific Meeting. The first trial was in
patients who were previously treated with anti-tumor necrosis factor (TNF)
agents and the second study was in patients who were active despite ongoing
treatment with methotrexate.
"In addition to reducing signs and symptoms, these data show
improvement in important measures of functional ability and quality of
life," said Jonathan Kay, M.D., Director, Clinical Trials, Rheumatology
Unit, Massachusetts General Hospital; Associate Clinical Professor of
Medicine, Harvard Medical School, and lead study investigator. "These data
support the potential benefit of golimumab in patients previously treated
with anti-TNF therapies or methotrexate."
In the study, GOlimumab After Former anti-TNF Therapy Evaluated in RA
(GO-AFTER), 50 mg and 100 mg doses of golimumab were studied in patients
who had active RA and who were previously treated with anti-TNF treatments,
but where anti-TNF treatment had been discontinued due to lack of efficacy
(58 percent), intolerance (17 percent) or other reasons (40 percent).
Patients continued to receive stable doses of methotrexate, sulfasalazine
and/or hydroxychloroquine if they were receiving them at baseline.
Golimumab-treated patients who had discontinued previous anti-TNF treatment
for any reason experienced significant improvements in physical function,
as measured by the Health Assessment Questionnaire (HAQ). HAQ assesses the
degree of difficulty a person has in accomplishing tasks in eight
functional areas (dressing, arising, eating, walking, hygiene, reaching,
gripping and other activities of daily living).
At week 24, the proportion of patients experiencing clinically relevant
improvement (increase in HAQ score of at least 0.25 from baseline) was
significantly greater for golimumab-treated patients compared with those
receiving placebo. More than half of patients in the combined golimumab
group (52 percent) achieved the measure, compared with 34 percent of
placebo-treated patients (P < 0.001). Also at week 24, patients receiving
golimumab experienced a mean improvement in HAQ of 0.27 +/- 0.51, compared
with an improvement of 0.05 +/- 0.51 among patients receiving placebo (P <
0.001). Importantly, among patients whose prior anti-TNF therapy was
discontinued due to lack of efficacy, golimumab-treated patients
experienced a mean improvement of 0.23 +/- 0.50 in HAQ, compared with an
average improvement of 0.06 +/- 0.51 for patients receiving placebo (P <
0.05).
At week 24, the combined golimumab group also experienced significantly
greater mean improvement in fatigue, 6.8 +/- 11.4, compared with an
improvement of 3.0 +/- 9.7 among patients treated with placebo (P < 0.001).
Patients were evaluated with the Functional Assessment of Chronic Illness
Therapy-Fatigue (FACIT-F), a 13-item questionnaire that assesses
self-reported fatigue and its impact on daily activities and function.
Improvements Seen in Patients Previously Treated with Methotrexate
A second Phase 3 study also presented at ACR evaluated 50 mg and 100 mg
doses of golimumab in RA patients who had active RA and were previously
treated with methotrexate. In GOlimumab FOR subjects With Active RA Despite
Methotrexate (GO-FORWARD), patients also indicated significant improvement
in fatigue. At week 24, the mean improvement in FACIT-F was 7.2 +/- 8.6 in
the combined golimumab group, compared with an improvement of 2.2 +/- 9.5
among patients receiving methotrexate alone (P < 0.001).
According to the Arthritis Foundation, in addition to joint pain and
swelling, RA may make daily functioning difficult and is frequently
associated with fatigue. "Patients with RA often say that fatigue is one of
their most frustrating symptoms because it makes it difficult for them to
participate in work or social activities," said Mark Genovese, M.D.,
professor of medicine at Stanford University School of Medicine, and lead
study investigator. "A reduction in fatigue would represent a tremendous
benefit and significantly impact the lives of patients with this disease."
Through week 24, patients in both dose groups receiving golimumab plus
methotrexate experienced significant improvement in physical function,
compared with patients receiving methotrexate alone. At 24 weeks, 70
percent of those receiving golimumab plus methotrexate experienced a
clinically relevant improvement in physical function, compared with 39
percent of patients receiving methotrexate alone (P < 0.0001). Also at week
24, the combined golimumab group achieved a mean improvement in HAQ of 0.46
+/- 0.53, compared with an improvement of 0.13 +/- 0.58 among patients
receiving methotrexate alone (P < 0.001).
Patients treated with golimumab also experienced significant
improvement in HRQOL, as assessed by the Physical Component Summary (PCS)
and Mental Component Summary (MCS) scores of the Short form (SF)-36
questionnaire. In the combined golimumab plus methotrexate group, the mean
improvement in PCS at week 14 was 7.7 +/- 8.1, compared with an improvement
of 2.5 +/- 8.1 in the group receiving methotrexate alone (P < 0.001).
Patients in the combined group also experienced a mean improvement in MCS
of 3.1 +/- 10.8 at week 24, compared with 0.8 +/- 9.7 among patients
receiving methotrexate alone (P < 0.05). The SF-36 is a 36-item
questionnaire that assesses impact in eight areas: physical functioning,
pain, vitality, social functioning, psychological functioning, general
health perceptions and role limitations due to physical and emotional
problems. Lower scores indicate poorer functioning and well- being.
The Biologics License Application (BLA) and Marketing Authorization
Application (MAA) for golimumab were submitted earlier in the year and are
currently under review by the U.S. Food and Drug Administration (FDA) and
European Medicines Agency (EMEA), respectively. The filings are based on
the extensive clinical development program for golimumab, including data
from five pivotal Phase 3 trials in RA, psoriatic arthritis and ankylosing
spondylitis.
About the GO-AFTER Trial
GO-AFTER was a Phase 3, multi-center, double-blind trial that included
461 patients with active RA of 8.65 years mean duration. All patients had
previously received at least one anti-TNF agent, with 25 percent (n=115)
having been treated with two therapies and 9 percent (n=43) with three.
Discontinuation of previous anti-TNF therapy was due to lack of efficacy
(58 percent), intolerance (17 percent) and other reasons (40 percent).
Patients were randomized to one of three treatment groups: subcutaneous
placebo, golimumab 50 mg or golimumab 100 mg every four weeks. At baseline,
66 percent of patients were receiving methotrexate; 5 percent and 7 percent
of patients were receiving sulfasalazine and hydroxychloroquine,
respectively. Patients continued to receive stable doses of methotrexate,
sulfasalazine and/or hydroxychloroquine if receiving them at baseline.
Golimumab was generally well tolerated in this study. Through week 24,
72 percent, 66 percent and 78 percent of patients in the placebo, golimumab
50 mg and golimumab 100 mg groups, respectively, experienced at least one
adverse event (AE). Ten percent of patients in the placebo group
experienced serious AEs, compared with 7 percent and 5 percent of patients
in the golimumab 50 mg and golimumab 100 mg groups, respectively. Serious
infections were reported in 3 percent, 3 percent and 1 percent of patients,
and injection site reactions (ISR) through week 16 occurred in 3 percent, 4
percent and 11 percent of patients in the placebo, golimumab 50 mg and
golimumab 100 mg groups, respectively. The most commonly reported ISR was
erythema, a redness of the skin due to inflammation. No serious or severe
ISRs were reported, and none led to the discontinuation of patients in the
study. Antibodies to golimumab were detected in 4 percent of
golimumab-treated patients (50 mg and 100 mg).
About the GO-FORWARD Trial
GO-FORWARD, a Phase 3, multi-center clinical trial included 444
patients with active RA. Adult patients with more than four tender and
swollen joints, despite methotrexate therapy, were randomly assigned to
receive golimumab (50 or 100 mg) plus methotrexate, golimumab 100 mg plus
placebo or placebo plus methotrexate at weeks 0, 4, 8, 12, 16 and 20. Data
were assessed at weeks 14 and 24. The co-primary endpoints were percentage
of patients achieving ACR 20 response at week 14 and improvement from
baseline in HAQ at week 24.
Through week 24, 68 percent of patients in both the combined golimumab
plus methotrexate groups and the placebo plus methotrexate group
experienced at least one AE. Nine percent of patients in the combined
golimumab plus methotrexate groups experienced a serious AE compared with 4
percent of patients receiving placebo plus methotrexate. Three percent of
patients in the combined golimumab plus methotrexate groups and 1 percent
in the group receiving placebo plus methotrexate experienced serious
infections. Rates of ISRs were 5 percent in the combined golimumab plus
methotrexate groups and 3 percent in the group receiving placebo plus
methotrexate. Two percent of golimumab-treated patients developed
antibodies. Four patients participating in the study developed
malignancies: one patient taking golimumab 100 mg plus methotrexate
developed breast cancer, one patient taking placebo plus methotrexate
developed Bowen's disease and squamous cell skin cancer, one patient taking
golimumab 100 mg plus placebo developed basal cell cancer, and one patient
taking golimumab 100 mg plus placebo developed squamous cell carcinoma. One
patient receiving golimumab 100 mg plus placebo died from diarrhea, colitis
and sepsis.
Anti-TNF therapies have been associated with serious and sometimes
fatal risks including the risk of tuberculosis and other serious
infections, malignancies, heart failure, central nervous system disorders,
reactivation of hepatitis B and other serious events.
About Rheumatoid Arthritis
RA is a chronic and debilitating disease that affects approximately 1.3
million people in the United States and more than three million people in
Europe. Signs and symptoms of RA include pain, stiffness and motion
restriction in multiple joints. Because RA is a progressive disease, it can
cause permanent joint deformity and severe disability if not diagnosed
early or if initial treatment is delayed. RA can occur at any age, but is
most common in adults 30-50 years old and is two-to-three times more
prevalent in women than in men. The cause of RA is unknown, although
genetic factors may contribute to the disease.
About Golimumab
Golimumab, the next-generation human anti-TNF-alpha monoclonal antibody
from Centocor Inc. and Schering-Plough Corporation, is currently in the
most comprehensive Phase 3 development program to date for an
anti-TNF-alpha biologic therapy. With ongoing studies for the treatment of
RA, including a study in a methotrexate-naive patient population, psoriatic
arthritis and ankylosing spondylitis, golimumab is being studied as an
every four-week subcutaneous injection and an intravenous (IV) infusion
therapy. Golimumab targets and neutralizes both the soluble and
membrane-bound forms of TNF- alpha.
Centocor discovered golimumab and has exclusive marketing rights to the
product in the United States. Pending regulatory approval, Schering-Plough
will assume exclusive marketing rights outside the United States except in
Japan, Indonesia and Taiwan where golimumab will be co-marketed by
Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical Kabushiki
Kaisha; Hong Kong, where golimumab will be exclusively marketed by
Janssen-Cilag; and China where golimumab will be exclusively marketed by
Xian-Janssen.
About Centocor
Centocor is harnessing the power of world-leading research and
biomanufacturing to deliver innovative biomedicines that transform
patients' lives. Centocor has already brought innovation to the treatment
of Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic
arthritis, ulcerative colitis, pediatric Crohn's disease and psoriasis.
The world leader in monoclonal antibody production and technology,
Centocor has brought critical biologic therapies to patients suffering from
debilitating immune disorders. Centocor is a wholly-owned subsidiary of
Johnson & Johnson.
CENTOCOR DISCLOSURE NOTICE: This press release contains
"forward-looking statements" as defined in the Private Securities
Litigation Reform Act of 1995. These statements are based on current
expectations of future events. If underlying assumptions prove inaccurate
or unknown risks or uncertainties materialize, actual results could vary
materially from Centocor's expectations and projections. Risks and
uncertainties include general industry conditions and competition; economic
conditions, such as interest rate and currency exchange rate fluctuations;
technological advances and patents attained by competitors; challenges
inherent in new product development, including obtaining regulatory
approvals; domestic and foreign health care reforms and governmental laws
and regulations; and trends toward health care cost containment. A further
list and description of these risks, uncertainties and other factors can be
found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for
the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well
as subsequent filings, are available online at http://www.sec.gov, http://www.jnj.com or
on request from Johnson & Johnson. Centocor does not undertake to update
any forward-looking statements as a result of new information or future
events or developments.
About Schering-Plough
Schering-Plough is an innovation-driven, science-centered global health
care company. Through its own biopharmaceutical research and collaborations
with partners, Schering-Plough creates therapies that help save and improve
lives around the world. The company applies its research-and-development
platform to human prescription and consumer products as well as to animal
health products. Schering-Plough's vision is to "Earn Trust, Every Day"
with the doctors, patients, customers and other stakeholders served by its
colleagues around the world. The company is based in Kenilworth, N.J., and
its Web site is http://www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press
release includes certain "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995, including statements
relating to the potential market for Golimumab. Forward-looking statements
relate to expectations or forecasts of future events. Schering-Plough does
not assume the obligation to update any forward-looking statement. Many
factors could cause actual results to differ materially from
Schering-Plough's forward-looking statements, including market forces,
economic factors, product availability, patent and other intellectual
property protection, current and future branded, generic or
over-the-counter competition, the regulatory process, and any developments
following regulatory approval, among other uncertainties. For further
details about these and other factors that may impact the forward-looking
statements, see Schering-Plough's Securities and Exchange Commission
filings, including Item 8.01 of Schering-Plough's Form 8-K filed October
21, 2008.
Centocor
http://www.centocor.com/centocor/index.html
Golimumab Faza 3 datele indicã îmbunãtãþire semnificativã Funcþia fizicã la pacienþii cu artrita reumatoida - Golimumab Phase 3 Data Show Significant Improvement In Physical Function In Patients With Rheumatoid Arthritis - articole medicale engleza - startsanatate