The first reported
findings from an international, Phase 3 study showed that more than
two-thirds of patients with moderate to severe plaque psoriasis receiving
two doses of ustekinumab (CNTO 1275) achieved at least a 75 percent
reduction in psoriasis at week 12, the primary endpoint of the study, as
measured by the Psoriasis Area and Severity Index (PASI 75). Importantly,
findings also showed that following one additional dose at week 16, a
substantial proportion of patients receiving ustekinumab maintained a PASI
75 response through week 28. Data from the study, presented at the World
Congress of Dermatology, involved more than 1,200 subjects and showed that
within four weeks of initiating treatment with ustekinumab, patients
experienced significant and clinically meaningful improvements in quality
of life measures compared with patients receiving placebo. Ustekinumab is a
new, fully-human monoclonal antibody with a novel mechanism of action that
targets the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23),
and is currently in Phase 3 development by Centocor, Inc. for the treatment
of moderate to severe plaque psoriasis.
"These findings provide further evidence of the role of IL-12/23 in the
pathogenesis of psoriasis and the promise that a new therapeutic approach
like ustekinumab may hold for dermatologists and their patients living with
this chronic, immune-related disease," said Craig Leonardi, MD, St. Louis
University Medical School and lead investigator of the study. "The efficacy
and safety data for ustekinumab in the treatment of psoriasis are exciting
for the dermatology community."
At week 12 of this Phase 3, multicenter, randomized, double-blind,
placebo-controlled trial, 67 percent of patients treated with 45 mg
ustekinumab (two 45 mg doses four weeks apart) and 76 percent of patients
treated with 90 mg ustekinumab (two 90 mg doses four weeks apart), achieved
PASI 75 compared with four percent of patients receiving placebo (P < 0.001
for each comparison versus placebo). Also at week 12, 42 percent of
patients in the 45 mg ustekinumab dosing group and 51 percent of patients
in the 90 mg ustekinumab dosing group achieved PASI 90, or nearly complete
clearance of psoriasis, compared with one percent of patients receiving
placebo (P < 0.001 for each comparison versus placebo). Similar response
rates were observed in the placebo group 12 weeks after crossover to
treatment with ustekinumab. After one additional dose at week 16, responses
were maintained through week 28, which is consistent with the maintenance
regimen of every 12-week dosing currently being evaluated in the Phase 3
program. Improvements in clinical measures were paralleled with
improvements in quality of life measures.
"These findings show that by targeting IL-12/23 with ustekinumab, we
may be able to offer dermatologists and patients a new, promising biologic
therapy with an infrequent dosing regimen for the treatment of psoriasis,"
said Jerome A. Boscia, MD, senior vice president, Clinical Research and
Development, Centocor, Inc. "We are encouraged by the results from the
Phase 3 program and look forward to collaborating with regulatory
authorities around the world in an effort to bring ustekinumab to
physicians and patients in need of new therapeutic options."
Additionally, data will be presented at the World Congress of
Dermatology that show that as early as week four patients treated with
either 45 mg or 90 mg ustekinumab experienced significant improvements in
quality of life measures compared with patients receiving placebo. At week
four, according to the Dermatology Life Quality Index (DLQI), a 10-item
questionnaire that measures the impact of psoriasis on quality of life and
patient burden of disease, median DLQI improvement was 6.0 for 45 mg and
6.0 for 90 mg versus 1.0 for placebo (each P < 0.001 versus placebo). An
improvement of five or more from baseline is considered to be clinically
meaningful. At week 12, 72 percent of patients receiving 45 mg ustekinumab
and 77 percent of patients receiving 90 mg ustekinumab achieved a reduction
of at least five points in DLQI score compared with 21 percent of patients
in the placebo group (P < 0.001 for each comparison versus placebo). Also
at week 12, a total of 37 percent of patients receiving the 45 mg
ustekinumab and 39 percent of patients receiving the 90 mg ustekinumab
achieved a DLQI score of zero, indicating no impact of psoriasis or the
treatment on quality of life, compared with one percent of those receiving
placebo (P < 0.001 for each comparison versus placebo). Upon crossing over
to treatment with ustekinumab, patients initially randomized to placebo
experienced similar improvements in DLQI after 12 weeks.
"Psoriasis is an inflammatory disease that can cause severe emotional,
physical and social burdens for patients," said Richard Langley, MD,
Dalhousie University, Halifax, Nova Scotia, Canada, and trial investigator.
"While more therapies have become available for the treatment of psoriasis
over the years, dermatologists need additional options to manage this
chronic disease, and ustekinumab would represent a much needed addition in
the treatment armamentarium."
About the PHOENIX 2 Trial
The Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled
Trial Evaluating the Efficacy and Safety of CNTO 1275 in the Treatment of
Subjects with Moderate to Severe Plaque-type Psoriasis Followed by
Long-term Extension 2 (PHOENIX 2) trial involved 1,230 patients with
chronic plaque psoriasis. Patients were randomized to receive
subcutaneously administered ustekinumab or placebo. Patients randomized to
receive ustekinumab received 45 mg or 90 mg doses at weeks 0 and 4 followed
by the same dose every 12 weeks. Patients in the placebo group crossed over
to receive either 45 mg or 90 mg doses of ustekinumab at weeks 12 and 16
and every subsequent 12 weeks. The primary end point of the study was the
proportion of patients who achieved PASI 75 at week 12.
Through week 12, the placebo-controlled portion of the study, the
percentages of study participants who experienced at least one adverse
event (AE) were comparable between the placebo group (49 percent) and the
ustekinumab 45 mg group (53 percent) and 90 mg group (48 percent).
Discontinuation due to an AE occurred in 0.2 percent and one percent of
patients in the respective ustekinumab groups, compared with two percent of
patients in the placebo group. Two percent and one percent of patients
receiving 45 mg or 90 mg ustekinumab, respectively, experienced at least
one serious AE compared with two percent of patients receiving placebo.
About Psoriasis
Psoriasis is a chronic, immune mediated disease that results from
inflammation in the skin and overproduction of skin cells that accumulate
on the surface causing red, scaly plaques that may itch and bleed. This
chronic inflammation is driven in part by IL-12 and IL-23, cytokines
involved in the regulation of the body's immune response. It is estimated
that 125 million people worldwide have psoriasis, including two percent of
both the U.S. and European populations, or some 7.5 million Americans and
10 million Europeans. Nearly one-quarter of people with psoriasis have
cases that are considered moderate to severe.
About Ustekinumab
Ustekinumab is a new, fully human monoclonal antibody in Phase 3
development by Centocor, Inc. for the treatment of moderate to severe
plaque psoriasis, and is being investigated as an infrequently-administered
subcutaneous injection. Ustekinumab is a novel biologic therapy that
targets interleukin 12 (IL-12) and interleukin 23 (IL-23), naturally
occurring proteins that are important in normalizing the immune system and
that are also believed to play a role in immune-mediated inflammatory
diseases.
Centocor discovered ustekinumab and has exclusive marketing rights to
the product in the United States. Janssen-Cilag companies will market
ustekinumab in all countries outside of the United States.
About Centocor, Inc.
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.
About Janssen Cilag
The Janssen-Cilag companies are members of the Johnson & Johnson Family
of Companies, the world's most comprehensive and broadly based manufacturer
of health care products, as well as a provider of related services, for the
consumer, pharmaceutical, and medical devices and diagnostics markets.
Janssen-Cilag companies have a long track record in developing and
marketing treatments for central nervous system disorders, pain management,
infectious diseases, gastrointestinal disorders and oncology.
(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 the Centocor's and Janssen-Cilag'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 31, 2006. Copies of this Form 10-K, as well as subsequent filings,
are available online at sec or on request from Johnson & Johnson.
Neither Centocor nor Janssen-Cilag undertakes to update any forward-
looking statements as a result of new information or future events or
developments.)
Centocor, Inc.
cnto1275wcd
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