More than half of patients
receiving every four week subcutaneous injections of golimumab (CNTO 148)
50 mg and 100 mg, an investigational therapy, experienced sustained
improvements in the joint and skin symptoms of active psoriatic arthritis
through six months with results sustained through one year.
Golimumab-treated patients also experienced improvements in health-related
quality of life (HRQOL) in the placebo-controlled portion of the study
(through week 24) along with the substantial improvements in physical
function and arthritis and psoriasis components of the disease. These
findings were presented at the American College of Rheumatology (ACR)
annual meeting.
"These results demonstrate long-term efficacy of every four week dosing
with golimumab in improving physical symptoms and functional ability as
well as improving quality of life," said Arthur Kavanaugh, M.D., Professor
of Medicine, University of California, San Diego, School of Medicine, and
lead study investigator. "The sustained effects of golimumab as
demonstrated in these study findings are encouraging for both the
physicians treating this condition and for the many patients living with
this potentially debilitating disease."
In the study, Golimumab - A Randomized Evaluation of Safety and
Efficacy in Subjects with Psoriatic Arthritis Using a Human Anti-TNF
Monoclonal Antibody (GO-REVEAL), 52 percent and 61 percent of patients
receiving golimumab 50 mg and 100 mg, respectively, achieved at least 20
percent improvement in arthritis signs and symptoms as measured by American
College of Rheumatology (ACR 20) response compared with 12 percent of
patients receiving placebo (P < 0.001) at week 24. Through one year, 78
percent of patients continuing in the golimumab 50 mg group and 74 percent
of patients continuing in the golimumab 100 mg group achieved ACR 20
response. Improvements were also observed in ACR 50 and ACR 70 measures
within the same timeframes. Thirty-two percent and 38 percent of patients
receiving golimumab 50 mg and 100 mg, respectively, achieved ACR 50 at week
24 compared with 4 percent of patients receiving placebo (P < 0.001).
Fifty-seven percent and 53 percent of patients continuing in the respective
golimumab dosing groups achieved ACR 50 response through one year. ACR 70
was achieved by 19 percent and 21 percent of patients receiving golimumab
50 mg and 100 mg, respectively, at 24 weeks compared to 1 percent of
patients receiving placebo (P < 0.001). These results were sustained
through one year with 43 percent of patients receiving golimumab 50 mg and
31 percent of patients receiving golimumab 100 mg achieving ACR 70.
The majority of patients treated with golimumab every four weeks
experienced improvements in disease activity as measured by good or
moderate Disease Activity Score 28 (DAS 28) response. At week 24, 64
percent and 78 percent of patients receiving golimumab 50 mg and 100 mg,
respectively, were DAS 28 responders, compared with 24 percent of patients
receiving placebo (P < 0.001). At one year, 93 percent and 86 percent of
patients continuing to receive golimumab 50 mg and 100 mg, respectively,
were DAS 28 responders.
Golimumab-treated patients also experienced substantial and sustained
improvements in psoriatic skin disease through one year. Patients with
greater than 3 percent Body Surface Area (BSA) psoriasis skin involvement
at baseline were evaluated for Psoriatic Area and Severity Index (PASI)
responses. At week 24, 56 percent of patients treated with golimumab 50 mg
and 66 percent of patients treated with golimumab 100 mg achieved at least
75 percent improvement in PASI (PASI 75), compared with 1.4 percent of
patients receiving placebo (P < 0.001). At one year, 62 percent and 69
percent of patients continuing in the golimumab 50 mg and 100 mg dose
groups, respectively, achieved PASI 75.
Improvements in Physical Function and Health-Related Quality of Life
In addition to improvements in signs and symptoms of psoriatic
arthritis, patients receiving every four week dosing with golimumab also
experienced clinically meaningful (increase of at least 0.3) improvement in
physical function, as measured by the Health Assessment Questionnaire
(HAQ). HAQ assesses the degree of difficulty a patient has in accomplishing
tasks in eight functional areas (dressing, arising, eating, walking,
hygiene, reaching, gripping and other activities of daily living.) At week
24, patients treated with golimumab 50 mg and 100 mg had a mean improvement
of 0.33 and 0.39 score, respectively, as compared to placebo patients
worsening by a mean of 0.01 score (P < 0.001). At one year, the mean
improvements were 0.49 in patients continuing to receive golimumab 50 mg
and 0.45 in patients continuing to receive golimumab 100 mg.
"These findings show golimumab to be promising in improving multiple
aspects of psoriatic arthritis, including key areas such as physical
function and productivity," said Philip Mease, M.D., Seattle Rheumatology
Associates, and Swedish Medical Center, Seattle, and lead study
investigator. "The results demonstrate that the effectiveness of golimumab
extends beyond the categories of signs and symptoms and improved the lives
of patients and those who care for them as measured through this analysis."
Patients in both golimumab groups experienced improvements in HRQOL as
measured by the Physical Component Summary (PCS) and Mental Component
Summary (MCS) scores of the Short form (SF)-36 questionnaire. SF-36
assesses well- being in patients along eight domains of health status,
including physical functioning, pain, vitality, social functioning,
psychological functioning, general health perceptions, and role limitations
due to physical and emotional problems.
At week 14, patients receiving golimumab 50 mg and 100 mg achieved a
mean change of 6.53 and 7.85 scores, respectively, in PCS compared with a
mean change of 0.63 among patients receiving placebo (P < 0.001). At six
months, these results improved to mean changes of 7.42 and 8.22 in the
respective treatment groups, compared with a mean improvement of 0.67 in
the placebo group (P < 0.001). Also at week 14, patients receiving
golimumab 50 mg achieved a mean change of 2.79 in MCS, while patients
receiving golimumab 100 mg achieved a mean change of 3.56, compared with a
mean change of 0.40 in patients treated with placebo (P < 0.05). At six
months, patients receiving golimumab 50 mg and 100 mg achieved a mean
change of 3.37 and 4.29, respectively, compared with 0.60 in
placebo-treated patients (P < 0.05).
Self-reported productivity was measured on a Visual Analog Scale (VAS),
a tool used to assess the patients' daily productivity at work, school or
home. Patients receiving golimumab 50 mg and 100 mg experienced
improvements in self-reported productivity, both at 16 and 24 weeks, while
patients receiving placebo reported no change in their productivity at 16
weeks and a decrease in productivity at 24 weeks. Additionally, caregivers
of golimumab-treated patients experienced a reduction of time lost from
work through week 24, compared with caregivers of patients treated with
placebo.
Nail, Enthesitis and Dactylitis Response
In patients with nail involvement or enthesitis at baseline, both
golimumab treatment groups experienced improvements in psoriatic nail
changes and enthesitis, as measured by the Nail Psoriasis Severity Index
(NAPSI) and the psoriatic arthritis-modified Maastricht Ankylosing
Spondylitis Enthesitis Score (MASES), respectively. In patients with
dactylitis at baseline, both golimumab dose groups also experienced
improvements in dactylitis, though the changes were not statistically
significant with the 50 mg dose. Enthesitis, an inflammation of a tendon,
ligament or joint capsule insertion to the bone, and dactylitis, a swelling
of digits in the hands or feet, are estimated to affect more than one-third
of people with psoriatic arthritis.
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
the 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 rheumatoid arthritis (RA), psoriatic
arthritis and ankylosing spondylitis.
About the GO-REVEAL Trial
The GO-REVEAL trial involved 405 adults with psoriatic arthritis.
Subjects with at least three swollen and tender joints and active psoriatic
skin lesions of at least 2 centimeters in diameter were randomly assigned
to receive subcutaneous injections of placebo or golimumab (50 or 100 mg)
at week 0 and every 4 weeks thereafter through the end of the study. At
week 16, patients with inadequate arthritis response were switched to
golimumab 50 mg (patients originally receiving placebo) or golimumab 100 mg
(patients originally receiving golimumab 50 mg). At week 24 all placebo
patients crossed over to active treatment with golimumab 50 mg. The primary
endpoint was ACR 20 response at week 14 for combined golimumab groups and
individual golimumab dose groups versus placebo.
Through week 24, the placebo-controlled portion of the study, 2 percent
of golimumab-treated patients experienced serious adverse events (SAE)
compared with 6 percent of patients in the placebo group. Injection site
reactions (ISR) occurred in 5 percent of patients receiving golimumab and 3
percent of patients receiving placebo. One case of prostate cancer and 2
cases of basal cell carcinoma were reported in golimumab-treated patients.
Through week 52, 5 percent of golimumab-treated patients experienced SAEs
and no tuberculosis or opportunistic infections were reported. Between
weeks 24 and 52, one colon and one small cell lung cancer were reported.
The small cell lung cancer patient died; another patient died in a climbing
accident. Through one year, golimumab had a similar safety profile to the
first 6 months.
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 Psoriatic Arthritis
Psoriatic arthritis is a chronic inflammatory arthropathy manifesting
with joint pain and swelling that can lead to joint destruction and
debilitation. It is frequently associated with inflamed, scaly, red patches
of skin psoriasis and psoriasis nail involvement. Symptoms may include
stiffness and tenderness of the joints and surrounding tissue and reduced
range of motion. Joints of the hands, wrists, knees, ankles, feet, lower
back and neck are commonly affected. Psoriasis affects an estimated two to
three percent of the world's population, and approximately one out of three
patients affected by psoriasis may develop psoriatic arthritis. Both men
and women are equally affected by psoriatic arthritis, most commonly
between the ages 30 and 50, in the peak of their productive years.
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
rheumatoid arthritis (RA), 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. Schering-Plough has 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, Inc. 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 sec, jnj 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 a global science-based health care company with
leading prescription, consumer and animal health products. Through internal
research and collaborations with partners, Schering-Plough discovers,
develops, manufactures and markets advanced drug therapies to meet
important medical needs. Schering-Plough's vision is to earn the trust of
the physicians, patients and customers served by its approximately 33,500
people around the world. The company is based in Kenilworth, N.J., and its
Web site is schering-plough.
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
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