San Antonio, Texas (ots/PRNewswire) -
- New Findings From a Second Pivotal Phase 3 Study Show Subjects
Receiving Ustekinumab Every 12 weeks Maintained Improvement From
Psoriasis Through One Year
One-year data from the second double blind, placebo-controlled
Phase 3 study PHOENIX 1 showed therapy with ustekinumab given every
12 weeks provided sustained, clinically meaningful improvement in the
treatment of moderate to severe plaque psoriasis through one year.
According to findings presented at the Annual Meeting of the American
Academy of Dermatology, 87 percent of patients responding to
ustekinumab 45 mg maintenance therapy and 91 percent of patients
responding to ustekinumab 90 mg maintenance therapy sustained at
least a 75 percent improvement in psoriasis through one year, as
measured by the Psoriasis Area and Severity Index (PASI 75). (i) (ii)
Ustekinumab is a new, human monoclonal antibody with a novel
mechanism of action that targets the cytokines interleukin-12 (IL-12)
and interleukin-23 (IL-23), naturally occurring proteins that are
important in the body's regulation of immune responses and that are
also believed to play a role in immune-mediated inflammatory
disorders, including psoriasis.
In December 2007, Centocor Inc. announced that a Biologics License
Application (BLA) for ustekinumab had been submitted to the U.S. Food
and Drug Administration (FDA) and Janssen-Cilag International NV
announced its submission of a Marketing Authorization Application
(MAA) to the European Medicines Agency (EMEA).
"These findings show that ustekinumab may control plaque psoriasis
with as few as four injections a year," says lead study investigator
Kenneth Gordon, MD, associate professor, Feinberg School of Medicine,
Northwestern University, and Head of Dermatology, Evanston
Northwestern Healthcare, Skokie, IL. "We are encouraged by the
results seen in clinical trials to date and the hope that ustekinumab
may hold for patients and the dermatology community."
The primary endpoint of 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 (PHOENIX
1) study examined the proportion of patients achieving at least a 75
percent improvement from baseline at week 12.
- Investigators reported findings from PHOENIX 1 that showed at
week 12, after two doses, 67 percent of patients receiving 45 mg
ustekinumab and 66 percent of patients receiving 90 mg ustekinumab
achieved PASI 75 (compared with 3 percent of patients receiving
placebo; P <0.001 for each comparison versus placebo).
- Furthermore, 42 percent of patients in the 45 mg ustekinumab
dosing group and 37 percent of patients in the 90 mg ustekinumab
dosing group achieved PASI 90, or nearly complete clearance of
psoriasis (vs. 2 percent placebo; P < 0.001).
Primary endpoint study findings from PHOENIX 1 were consistent
with the week 12 primary endpoint findings reported at the World
Congress of Dermatology in October 2007 from another study, 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).
In the PHOENIX 1 study, subjects who received 45 mg or 90 mg of
ustekinumab and consistently achieved a 75% improvement from baseline
were randomized at week 40 to either continue treatment or switch to
placebo, with levels of response to maintenance therapy measured at
- Of those patients who continued treatment with ustekinumab 45 mg
and ustekinumab 90 mg dosing, 87 percent and 91 percent,
respectively, had a sustained PASI 75 response (vs. 64 percent and 62
percent placebo; P less than or equal to 0.001 for 45 mg comparison;
P < 0.001 for 90 mg comparison).
- Also at week 40, 66 percent and 73 percent of patients achieved
PASI 90 after receiving either 45 mg ustekinumab or 90 mg
ustekinumab, respectively, and response rates remained stable through
week 52 with continued treatment (vs. 37 percent and 38 percent
Through week 12 (the placebo-controlled portion of the study) the
percentages of study participants experiencing at least one adverse
event (AE) were comparable between the placebo group (48 percent) and
the ustekinumab 45 mg group (57 percent) and 90 mg group (51
percent). Those patients experiencing at least one serious AE were
reported as follows: 1 percent and 2 percent of patients receiving 45
mg or 90 mg ustekinumab, respectively (vs. 2 percent placebo).
After the randomization at week 40 to either continuing treatment
or withdrawal to placebo, 46 and 49 percent of patients continuing
treatment with 45 mg and 90 mg ustekinumab, respectively, experienced
at least one AE (vs. 56 and 48 percent placebo). Serious AEs were
observed in 0 and 1 percent of patients continuing treatment with 45
mg and 90 mg ustekinumab (vs. 0 and 2 percent placebo).
"The Phase 3 efficacy and safety data for ustekinumab are
promising and offer hope to a patient population in need of
additional therapeutic options," says Kim Papp, MD, PhD, Probity
Medical Research, Waterloo, Ontario, and lead study investigator.
About the PHOENIX 1 Trial
PHOENIX 1 evaluated the efficacy and safety of ustekinumab in the
treatment of 766 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 12
weeks thereafter. The primary endpoint of the study was the
proportion of patients achieving PASI 75 at week 12. Patients
responding to ustekinumab through week 40 were randomized to either
continue treatment with ustekinumab or were switched to placebo.
Psoriasis is a chronic, immune-mediated disease, which results
from the overproduction of skin cells, resulting in their
accumulation on the surface of the skin, which causes red, scaly
plaques that may itch and bleed. It is estimated that approximately
7.5 million people in the United States and 10 million Europeans are
living with psoriasis and nearly one-quarter of those people have
cases that are considered moderate to severe.1
Ustekinumab is a new, 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
regulating the immune system and that are also believed to play a
role in immune-mediated inflammatory disorders.
Centocor discovered ustekinumab and has exclusive marketing rights
to the product in the United States. Janssen-Cilag companies have
exclusive marketing rights in all countries outside of the United
States. Centocor, Inc. and the Janssen-Cilag companies are members of
the Johnson & Johnson family of companies.
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.
About Janssen-Cilag International NV and Janssen-Cilag
Janssen-Cilag International NV and 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.
1. National Psoriasis Foundation. About Psoriasis: Statistics.
Available at: http://www.psoriasis.org/about/stats. Accessed December
(i) Kim Papp, MD, PhD, Newman Yeilding, MD, Yuhua Wang, PhD, Alexa
B. Kimball, MD, MPH, CNTO 1275 (anti-IL-12/23p40) Treatment of
Psoriasis: Phase 3 Trial Results, Kim Papp, MD, PhD, Newman Yeilding,
MD, Yuhua Wang, PhD, Alexa B. Kimball, MD, MPH, Abstract presented at
the AAD 2008, San Antonio.
(ii) Kenneth B. Gordon, MD, Newman Yeilding, MD, Shu Li, MS, Craig
Leonardi, MD, Long-term Continuous Maintenance Therapy With CNTO 1275
(anti-IL-12/23p40) as Treatment for Psoriasis: Phase 3 Trial Results,
Abstract presented at the AAD 2008, San Antonio.
ots Originaltext: Janssen-Cilag
Im Internet recherchierbar: http://www.presseportal.ch
Investor contacts: Louise Mehrotra, Johnson & Johnson, Phone:
+1-732-524-6491; Tina Pinto, Johnson & Johnson, Phone:
+1-732-524-2034; Media contact: Satu Schmidt, Janssen-Cilag, Phone: