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New Phase 3 Findings Show STELARA® Significantly Reduced Signs and Symptoms of Active Psoriatic Arthritis

New Phase 3 Findings Show STELARA® Significantly Reduced Signs and Symptoms of
                          Active Psoriatic Arthritis

STELARA Continued to Provide Benefit in Psoriatic Arthritis Signs and Symptoms
through Week 52 in One Phase 3 Trial

PR Newswire

WASHINGTON, Nov. 12, 2012

WASHINGTON, Nov. 12, 2012 /PRNewswire/ --Janssen Research & Development, LLC
(Janssen) announced today new findings from PSUMMIT II, a Phase 3
investigational study that showed patients with active psoriatic arthritis,
including those previously treated with one to five tumor necrosis factor
(TNF) inhibitors, receiving the interleukin (IL)-12/23 inhibitor STELARA^®
(ustekinumab) demonstrated significant improvements in signs and symptoms of
the disease. Significantly more patients receiving either STELARA 45 mg or 90
mg achieved at least a 20 percent improvement in signs and symptoms according
to American College of Rheumatology criteria (ACR 20) at week 24, the primary
endpoint, than did patients receiving placebo regardless of background
methotrexate use. During a late-breaker session of PSUMMIT 1, the initial
Phase 3 study, investigators will present 52-week data that showed improvement
in efficacy of STELARA over time in treating signs and symptoms of the
disease. These data are being presented at the 2012 Annual Meeting of the
American College of Rheumatology. 

In the Phase 3 Multicenter, Randomized, Double-blind, Placebo‑controlled trial
of Ustekinumab, a Fully Human anti-IL-12/23p40 Monoclonal Antibody,
Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis
Including Those Previously Treated with Biologic Anti-TNF-alpha Agent(s)
(PSUMMIT II) study, patients with active psoriatic arthritis despite treatment
with disease-modifying antirheumatic drugs (DMARDs), nonsteroidal
anti-inflammatory drugs (NSAIDs) and/or anti-TNF-alpha therapy (not intended
as a superiority or comparative claim versus TNF inhibitors) were randomized
to receive subcutaneous STELARA 45 mg or 90 mg or placebo at weeks 0, 4 and
then every 12 weeks. At week 24, the primary endpoint was met as
statistically significantly greater proportions of patients achieving ACR 20
responses (a standard measure of improvement in disease activity) were
observed in patients receiving STELARA 45 mg (43.7 percent of patients) or
STELARA 90 mg (43.8 percent of patients) compared with 20.2 percent of
patients receiving placebo (P < 0.001 for both comparisons). Among patients
previously treated with TNF inhibitors, 36.7 percent of patients and 34.5
percent of patients receiving STELARA 45 mg or 90 mg, respectively, achieved
ACR 20 at week 24 compared with 14.5 percent of patients receiving placebo (P
= 0.006 for STELARA 45 mg, P = 0.011 for STELARA 90 mg).

"TNF inhibitors are the only approved biologic treatment option for psoriatic
arthritis, but not all patients benefit from these currently available
treatments," said Christopher Ritchlin, M.D., M.P.H., Professor of Medicine
and Director of the Rheumatology Fellowship Program and the Clinical
Immunology Research Center at the University of Rochester Medical Center, and
lead study investigator. "A biologic therapy with a different mechanism of
action, like ustekinumab, which has shown benefit in the treatment of
psoriatic arthritis in two Phase 3 studies, is exciting for the rheumatology
community."

In PSUMMIT II, significantly greater proportions of patients receiving STELARA
45 or 90 mg achieved ACR 50 at week 24 compared with placebo (17.5 and 22.9
percent vs. 6.7 percent, P = 0.018 for STELARA 45 mg, P = 0.001 for STELARA 90
mg). ACR 70 responses for both STELARA groups were greater, though not
significantly, than for the placebo group at week 24. Of patients with at
least three percent body surface involvement of psoriasis at the start of
PSUMMIT II, 51.3 percent and 55.6 percent of patients receiving STELARA 45 mg
and 90 mg achieved at least a 75 percent improvement in psoriasis,
respectively, as measured by the Psoriasis Area Severity Index (CASI 75),
compared with five percent of patients receiving placebo (P < 0.001 for both
comparisons). Significant improvements from baseline to week 24 were also
observed in physical function, as measured by the Health Assessment
Questionnaire Disability Index (HAQ-DI), in the STELARA 45 mg and 90 mg
treatment groups compared with placebo-treated patients (P = 0.001 for STELARA
45 mg, P < 0.001 for STELARA 90 mg).

Similar proportions of patients experienced at least one adverse event (AE)
through week 16, the placebo-controlled period, among those receiving STELARA
45 mg (63.1 percent), STELARA 90 mg (60.6 percent) and placebo (54.8 percent)
with infections being the most common AE. Serious AEs reported among the
groups were: STELARA 45 mg (zero percent), STELARA 90 mg (1.0 percent) and
placebo (4.8 percent). No cases of tuberculosis (TB), opportunistic
infections, major adverse cardiovascular events (MACE) or deaths occurred.
Through week 24, one serious infection due to complications of pre-existent
interstitial lung disease was reported in the placebo group and one skin
malignancy (squamous cell carcinoma in situ) occurred in the STELARA 90 mg
group.

Improvement of Signs and Symptoms by STELARA in Patients with Active Psoriatic
Arthritis: Week 52 Results of the Phase 3, Multicenter, Double-blind,
Placebo-controlled PSUMMIT I Study

Findings from the Phase 3 Multicenter, Randomized, Double-blind,
Placebo-controlled trial of Ustekinumab, a Fully Human anti-IL-12/23p40
Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active
Psoriatic Arthritis (PSUMMIT I) study are the focus of a late breaker oral
presentation. PSUMMIT I is evaluating the efficacy and safety of STELARA in
patients with active psoriatic arthritis despite treatment with conventional
therapy (anti-TNF-alpha naive) through 108 weeks. Patients were randomized to
receive subcutaneous STELARA 45 mg or 90 mg or placebo at weeks 0, 4 and then
every 12 weeks. At week 24, 42.4 percent and 49.5 percent of patients
receiving STELARA 45 mg and 90 mg, respectively, achieved ACR 20, the primary
endpoint, compared with 22.8 percent of patients receiving placebo (P < 0.001
for both comparisons). Patients who qualified for early escape at week 16
were considered non-responders for the primary and major secondary analyses at
week 24. Following week 24 assessment, patients receiving STELARA 45 mg and
90 mg continued to receive every-12-week maintenance therapy, and placebo
patients were crossed over to receive STELARA 45 mg induction (at weeks 24 and
28) and maintenance therapy every 12 weeks thereafter. Observed data showed
that signs and symptoms continued to increase between weeks 24 and week 52,
with 55.7 percent, 60.3 percent and 65.2 percent of patients in the STELARA 45
mg, STELARA 90 mg and placebo crossover groups, respectively, demonstrating
ACR 20 response.

"Long-term management of thesigns and symptoms of disease is essential in the
treatment of psoriatic arthritis, a systemic inflammatorydisease that can be
marked by chronic pain and dysfunction," said Arthur Kavanaugh, M.D.,
Professor ofMedicine, and Director of the Center for Innovative Therapy at
the University of California, San Diego, and co-principal investigator.
"These results build on previously reported24-week data from the PSUMMIT I
trial of ustekinumab and demonstrate efficacy and improvements in disease
activity at one year for patients living with psoriatic arthritis."

ACR 50 and ACR 70 response rates increased from week 24 through week 52 among
patients receiving STELARA maintenance therapy. At week 24, among patients
receiving STELARA 45 mg, 24.9 percent achieved ACR 50 compared with 8.7
percent in the placebo group (P < 0.001), which increased to 31.4 percent at
week 52, and 12.2 percent achieved ACR 70 compared with 2.3 percent in the
placebo group (P < 0.001) at week 24, which increased to 18 percent at week
52. Similar changes were observed in the STELARA 90 mg group at week 24 as
27.9 percent achieved ACR 50 compared with 8.7 percent in the placebo group (P
< 0.001), which increased to 37 percent at week 52, and 14.2 percent achieved
ACR 70 compared with 2.3 percent in the placebo group (P < 0.001) at week 24,
which increased to 21.2 percent at week 52. Investigators also reported
continued improvements in physical function and skin symptoms through the end
of the study, with nearly half of patients demonstrating clinically meaningful
change from baseline in HAQ-DI scores, and more than two-thirds of patients
achieving PASI 75 at week 52.

Among study participants affected with enthesitis (inflammation of the
entheses, the sites where tendons or ligaments attach to bone, n=425) or
dactylitis (inflammation of the finger or toe, n=286) at baseline, patients
receiving STELARA achieved clinically relevant improvements in both measures
at week 24 and week 52. At week 24, median percent changes in enthesitis
scores (-42.9 for STELARA 45 mg and -50.0 for STELARA 90 mg) and dactylitis
scores (-75.0 for STELARA 45 mg and -70.8 for STELARA 90 mg) were
significantly higher than those seen for patients receiving placebo (P < 0.001
for all comparisons). Improvements in enthesitis scores (-83.3, -74.2 and
-87.5) and dactylitis scores (-100 in all patients) in the STELARA 45 mg, 90
mg and crossover groups, respectively, continued through week 52.

A similar proportion of patients experienced at least one AE or serious AE
through week 16, the placebo-controlled period of PSUMMIT I. Safety through
week 52 was consistent with that observed during the placebo-controlled period
between STELARA 45 mg and 90 mg groups in the incidence of AEs (66.8 percent
and 64.7 percent, respectively) and serious AEs (5.9 percent and 3.4 percent,
respectively). No malignancies, cases of TB, opportunistic infections or
deaths occurred through week 52. Investigators reported three MACE in
STELARA-treated patients in patients with multiple pre-existing cardiovascular
risk factors.

About PSUMMIT II

The PSUMMIT II trial is a Phase 3, multicenter, randomized, double-blind,
placebo‑controlled study including 312 adults with psoriatic arthritis
designed to evaluate the efficacy and safety of STELARA in adults with
psoriatic arthritis. The trial included patients diagnosed with active
psoriatic arthritis who had at least five tender and five swollen joints and
C-reactive protein (CRP) levels of at least 0.3 mg/dL despite treatment with
DMARDs and/or NSAIDs and/or prior exposure to anti-TNF treatment, including 8
to 14 weeks of exposure to currently available anti-TNF-alpha treatments
and/or documented evidence of anti-TNF-alpha intolerance/toxicity with 8 to 14
weeks exposure. Concurrent methotrexate use was permitted but not mandated.
Within the trial, 180 patients had prior exposure to anti-TNF-alpha treatments
and 132 patients were anti-TNF-alpha naive.

Patients were randomized to three groups: STELARA 45 mg or STELARA 90 mg at
weeks 0, 4, and then every 12 weeks or placebo. At week 16, patients with
less than a five percent improvement in tender and swollen joint counts were
entered into blinded early escape to receive STELARA 45 mg (patients receiving
placebo) or STELARA 90 mg (patients receiving STELARA 45 mg). The primary
endpoint was ACR 20 response at week 24. Secondary endpoints at week 24
included ACR 50 and ACR 70 response, Disease Activity Score (DAS) 28 using CRP
(DAS28-CRP) response, PASI 75 in patients with at least three percent body
surface area involvement at baseline, improvements in enthesitis and
dactylitis scores and improvements in HAQ-DI scores.

About PSUMMIT I

The PSUMMIT I trial is a Phase 3, multicenter, randomized, double-blind,
placebo-controlled study including 615 adults with psoriatic arthritis
designed to evaluate the efficacy and safety of STELARA in adults with
psoriatic arthritis. The trial included patients diagnosed with active
psoriatic arthritis who had at least five tender and five swollen joints and
CRP levels of at least 0.3 mg/dL despite treatment with DMARDs and/or NSAIDs.
Patients were naive to treatment with anti-TNF-alpha therapies and/or IL-12/23
inhibitors.

Patients were randomized to three groups: STELARA 45 mg or STELARA 90 mg at
weeks 0, 4 and then every 12 weeks or placebo. At week 16, patients with less
than a five percent improvement in tender and swollen joint counts were
entered into blinded early escape to receive STELARA 45 mg (patients receiving
placebo) or STELARA 90 mg (patients receiving STELARA 45 mg). The primary
endpoint was ACR 20 response at week 24. Secondary endpoints at week 24
included ACR 50 and ACR 70 response, DAS28-CRP response, PASI 75 in patients
with at least three percent body surface area involvement at baseline,
improvements in enthesitis and dactylitis scores and improvements in HAQ-DI
scores. Safety and efficacy results were reported through week 52 in the
trial. Initial week 24 results were presented earlier this year at the 2012
EULAR Annual Congress.

About Psoriatic Arthritis

Psoriatic arthritis is a chronic immune-mediated inflammatory disease
characterized by both joint inflammation and the skin lesions associated with
psoriasis that affects up to 37 million people worldwide.[1] While estimates
of the prevalence of psoriatic arthritis among people living with psoriasis
vary, up to 30 percent may develop inflammatory arthritis.[2] Though the
exact cause of psoriatic arthritis is unknown, genes, the immune system and
environmental factors are all believed to play a role in the onset of the
disease.[2]

About STELARA

STELARA, a human interleukin (IL)-12 and IL-23 antagonist, is approved for the
treatment of adult patients (18 years or older) with moderate to severe plaque
psoriasis who are candidates for phototherapy or systemic therapy. IL-12 and
IL-23 are naturally occurring proteins that are believed to play a role in
psoriasis.

STELARA is under investigation in Phase 3 development programs for the
treatment of active psoriatic arthritis and moderate to severe Crohn's
disease.

Janssen Biotech, Inc. discovered STELARA and has exclusive marketing rights to
the product in the United States. The Janssen pharmaceutical companies
maintain exclusive worldwide marketing rights to STELARA, which is currently
approved for the treatment of moderate to severe plaque psoriasis in 69
countries. For more information about STELARA, visit www.STELARAinfo.com.

Important Safety Information

STELARA^® is a prescription medicine that affects your immune system.
STELARA^® can increase your chance of having serious side effects including:

Serious Infections

STELARA^® may lower your ability to fight infections and may increase your
risk of infections. While taking STELARA^®, some people have serious
infections, which may require hospitalization, including tuberculosis (TB),
and infections caused by bacteria, fungi, or viruses.

  oYour doctor should check you for TB before starting STELARA^® and watch
    you closely for signs and symptoms of TB during treatment with STELARA^®.
  oIf your doctor feels that you are at risk for TB, you may be treated for
    TB before and during treatment with STELARA^®.

You should not start taking STELARA^® if you have any kind of infection unless
your doctor says it is okay.

Before starting STELARA^®, tell your doctor if you  think you have an
infection or have symptoms of an infection such as:

  ofever, sweats, or chills
  omuscle aches
  ocough
  oshortness of breath
  oblood in your phlegm
  oweight loss
  owarm, red, or painful skin or sores on your body
  odiarrhea or stomach pain
  oburning when you urinate or urinate more often than normal
  ofeel very tired
  oare being treated for an infection
  oget a lot of infections or have infections that keep coming back
  ohave TB, or have been in close contact with someone who has TB

After starting STELARA^®, call your doctor right away  if you have any
symptoms of an infection (see above).

STELARA^® can make you more likely to get infections or make an infection that
you have worse. People who have a genetic problem where the body does not make
any of the proteins interleukin 12 (IL-12) and interleukin 23 (IL-23) are at a
higher risk for certain serious infections that can spread throughout the body
and cause death. It is not known if people who take STELARA^® will get any of
these infections because of the effects of STELARA^® on these proteins.

Cancer

STELARA^® may decrease the activity of your immune system and increase your
risk for certain types of cancer. Tell your doctor if you have ever had any
type of cancer.

Reversible posterior leukoencephalopathy syndrome (RPLS)

RPLS is a rare condition that affects the brain and can cause death. The cause
of RPLS is not known. If RPLS is found early and treated, most people recover.
Tell your doctor right away if you have any new or worsening medical problems
including: headache, seizures, confusion, and vision problems.

Serious Allergic Reactions

Serious allergic reactions can occur. Get medical help right away if you have
any symptoms such as: feeling faint, swelling of your face, eyelids, tongue,
or throat, trouble breathing, throat or chest tightness, or skin rash.

Before receiving STELARA^®, tell your doctor if you:

  ohave any of the conditions or symptoms listed above for serious
    infections, cancer, or RPLS
  ohave recently received or are scheduled to receive an immunization
    (vaccine). People who take STELARA^® should not receive live vaccines.
    Tell your doctor if anyone in your house needs a vaccine. The viruses used
    in some types of vaccines can spread to people with a weakened immune
    system, and can cause serious problems. You should not receive the BCG
    vaccine during the one year before taking STELARA^® or one year after you
    stop taking STELARA^®. Non-live vaccinations received while taking
    STELARA^® may not fully protect you from disease.
  oare receiving or have received allergy shots, especially for serious
    allergic reactions
  oever had an allergic reaction to STELARA^®
  oreceive phototherapy for your psoriasis
  ohave any other medical conditions
  oare pregnant or plan to become pregnant. It is not known if STELARA^® 
    will harm your unborn baby. You and your doctor should decide if you will
    take STELARA^®.
  oare breast-feeding or plan to breast-feed. It is thought that STELARA^®
    passes into your breast milk. You should not breast-feed while taking
    STELARA^® without first talking to your doctor.

Tell your doctor about all the medicines you take, including prescription and
non-prescription medicines, vitamins, and herbal supplements. Especially tell
your doctor if you take:

  oother medicines that affect your immune system
  ocertain medicines that can affect how your liver breaks down other
    medicines

Common side effects of STELARA^® include: upper respiratory infections,
headache, and tiredness

These are not all of the side effects with STELARA^®. Tell your doctor about
any side effect that bothers you or does not go away. Ask your doctor or
pharmacist for more information.

Please read the Medication Guide for STELARA^® and discuss any questions you
have with your doctor.

You are encouraged to report negative side effects of prescription drugs to
the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

The U.S. full prescribing information for STELARA^® can be accessed at the
following link: http://www.stelarainfo.com/pdf/PrescribingInformation.pdf.

About Janssen Research & Development, LLC

At Janssen Research & Development, LLC, we are united and energized by one
mission—to discover and develop innovative medicines that ease patients'
suffering, and solve the most important unmet medical needs of our time. As
one of the Janssen Pharmaceutical Companies of Johnson & Johnson, our strategy
is to identify the biggest unmet medical needs and match them with the best
science, internal or external, to find solutions for patients worldwide. We
leverage our world-class discovery and development expertise, and operational
excellence, to bring innovative, effective treatments in oncology, immunology,
neuroscience, infectious diseases and vaccines, and cardiovascular and
metabolic diseases. For more information on Janssen R&D, visit
http://www.janssenrnd.com/.

[1] About Psoriasis: Statistics. National Psoriasis Foundation.
http://www.psoriasis.org/learn_statistics. Accessed November 12, 2012.
[2] About Psoriatic Arthritis. National Psoriasis Foundation.
http://psoriasis.org/psoriatic-arthritis. Accessed November 12, 2012.

SOURCE Janssen Research & Development, LLC

Website: http://www.janssenrnd.com
Contact: Media Contact: Brian Kenney, Office: +1-215-628-7010, Mobile:
+1-215-620-0111; Investor Contacts: Louise Mehrotra, Johnson & Johnson,
Office: +1-732-524-6491, or Stan Panasewicz, Johnson & Johnson, Office:
+1-732-524-2524
 
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