Anti-Interleukin-23 Monoclonal Antibody Guselkumab Shows Significant Efficacy in Treatment Of Moderate To Severe Plaque

Anti-Interleukin-23 Monoclonal Antibody Guselkumab Shows Significant Efficacy
             in Treatment Of Moderate To Severe Plaque Psoriasis

Results from Phase 2b X-PLORE Study through Week 40 Report Efficacy of
Guselkumab across Multiple Dosing Regimens and Compared with Adalimumab

PR Newswire

DENVER, March 24, 2014

DENVER, March 24, 2014 /PRNewswire/ --New findings presented for the first
time at the 2014 Annual Meeting of the American Academy of Dermatology (AAD)
showed up to 86 percent of patients with moderate to severe plaque psoriasis
receiving guselkumab (CNTO 1959) achieved a Physician's Global Assessment
(PGA) score of cleared or minimal at week 16, the study's primary
endpoint.The Phase 2b Janssen Research & Development, LLC (Janssen)-sponsored
X-PLORE study demonstrated significantly higher levels of efficacy at all
doses of guselkumab studied at week 16 when compared with the placebo
group.Similar proportions of patients achieving a PGA score of cleared or
minimal were observed at week 40 of the study.The trial also included an
adalimumab arm.Guselkumab is an investigational human monoclonal antibody
with a novel mechanism of action that targets the protein interleukin (IL)-23,
and is being developed as a subcutaneously administered therapy for the
treatment of moderate to severe plaque psoriasis. 

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"The efficacy of guselkumab in the treatment of moderate to severe plaque
psoriasis looks promising according to these Phase 2b study results," said
Kristina Callis Duffin, M.D., Assistant Professor of Dermatology, University
of Utah School of Medicine, study investigator."As a practicing
dermatologist, I look forward to understanding how investigational therapies
like guselkumab may meet the needs of patients with psoriasis in the future."

Patients participating in the Phase 2b, randomized, placebo- and active
comparator-controlled, parallel-group, multicenter dose-ranging 7-arm X-PLORE
study received subcutaneous injections of either placebo, guselkumab (five
dose groups: 5 mg at weeks 0, 4 then every 12 weeks; 15 mg every 8 weeks; 50
mg at weeks 0, 4 then every 12 weeks; 100 mg every 8 weeks; and 200 mg at
weeks 0, 4 then every 12 weeks) or adalimumab (80 mg initial dose, followed
by 40 mg every other week starting one week after initial dose). At week 16,
significantly higher proportions of guselkumab-treated patients achieved the
primary endpoint of a Physician Global Assessment (PGA) score of cleared (0)
or minimal (1) compared with patients receiving placebo across all dose
groups: 34 percent (5 mg at weeks 0, 4 then every 12 weeks); 61 percent (15 mg
every 8 weeks); 79 percent (50 mg at weeks 0, 4 then every 12 weeks); 86
percent (100 mg every 8 weeks); 83 percent (200 mg at weeks 0, 4 then every 12
weeks); 7 percent (placebo group) [P = 0.002 for 5 mg; P < 0.001 for all other
doses].A PGA score indicates a physician's assessment of the severity of
psoriasis, with 0 indicating no psoriasis (clear of disease) and 5 indicating
most severe disease. 

Significantly higher proportions of patients receiving guselkumab achieved at
least a 75 percent improvement in psoriasis as measured by the Psoriasis Area
Severity Index (PASI 75) at week 16: 44 percent (5 mg at weeks 0, 4 then every
12 weeks); 76 percent (15 mg every 8 weeks); 81 percent (50 mg at weeks 0, 4
then every 12 weeks); 79 percent (100 mg every 8 weeks); and 81 percent (200
mg at weeks 0, 4 then every 12 weeks), compared with 5 percent of patients
receiving placebo (P < 0.001). At week 16, PASI 90 responses, or at least 90
percent improvement in psoriasis, were also reported in significantly higher
proportions of guselkumab-treated patients: 34 percent (5 mg at weeks 0, 4
then every 12 weeks); 34 percent (15 mg every 8 weeks); 45 percent (50 mg at
weeks 0, 4 then every 12 weeks); 62 percent (100 mg every 8 weeks); and 57
percent (200 mg at weeks 0, 4 then every 12 weeks), compared with 2 percent of
patients receiving placebo (P < 0.001). In the adalimumab treatment group at
week 16, 58 percent, 70 percent and 44 percent of patients achieved PGA scores
of 0 or 1, PASI 75 response and PASI 90 response, respectively. 

Beyond week 16, the proportions of patients achieving a PGA score of 0 or 1, a
PASI 75 response and a PASI 90 response remained consistent or showed
additional improvement over time for guselkumab through the final dosing visit
at week 40.

"Within the past decade, Janssen has advanced the scientific understanding of
psoriasis and therapeutic options for the treatment of this complex,
immune-mediated disease," said Newman Yeilding, M.D., Head of Immunology
Development, Janssen Research & Development, LLC. "We look forward to
progressing guselkumab into Phase 3 development based on the findings from the
X-PLORE study and we remain focused and committed to advancing the treatment
of psoriasis."

Through week 16, the placebo-controlled period, adverse events (AEs) were
reported in 50 percent of patients receiving guselkumab (combined groups), 56
percent of patients receiving adalimumab and 52 percent of patients receiving
placebo; 1 percent, 2 percent and 2 percent of patients reported at least one
serious AE in these respective groups. Serious infections occurred in two
patients treated with guselkumab (appendicitis, lung abscess). No
malignancies or major adverse cardiovascular events (MACE) were observed in
any group. 

Through week 52, AEs were reported in 66 percent of patients receiving
guselkumab (combined groups) and 72 percent of patients receiving adalimumab;
3 percent and 5 percent reported at least one serious AE in these respective
groups. No additional serious infections occurred in guselkumab-treated
patients; one serious infection occurred in a patient treated with adalimumab
(pneumonia). There were no cases of tuberculosis or opportunistic
infections.One guselkumab-treated patient reported a malignancy (cervical
intraepithelial neoplasia III, including carcinoma in situ). Three MACE were
reported in guselkumab-treated patients (one fatal myocardial infarction [MI],
one nonfatal MI, one cerebrovascular accident), all of whom had multiple
pre-existing cardiovascular risk factors.

About XPLORE
X-PLORE, a Phase 2b, randomized, placebo- and active comparator-controlled,
parallel-group, multicenter dose-ranging study, investigated subcutaneous
injections of five doses of guselkumab compared with placebo and adalimumab in
patients with moderate to severe plaque psoriasis, defined by a PASI greater
than or equal to 12, PGA greater than or equal to 3 and body surface area
(BSA) involvement of at least 10 percent who are candidates for systemic or
phototherapy.Patients (n=293) were randomized in the seven-arm study to
receive placebo, guselkumab (five dose groups: 5 mg at weeks 0, 4 then every
twelve weeks; 15 mg every eight weeks; 50 mg at weeks 0, 4 then every 12
weeks; 100 mg every 8 weeks; and 200 mg at weeks 0, 4 then every 12 weeks, or
adalimumab (80 mg initial dose, followed by 40 mg every other week starting
one week after initial dose). The primary endpoint was the proportion of
patients who achieve a Physician's Global Assessment (PGA) score of cleared
(0) or minimal (1) at week 16. Secondary endpoints include at least a 75
percent improvement in psoriasis as measured by the Psoriasis Area Severity
Index (PASI 75) at week 16.

About Guselkumab (CNTO 1959)
Guselkumab is a human monoclonal antibody with a novel mechanism of action
that targets the protein interleukin (IL)-23, and is in clinical development
as a subcutaneously administered therapy for the treatment of moderate to
severe plaque psoriasis. Guselkumab is also being investigated for the
treatment of active rheumatoid arthritis in a Phase 2 study. 

About Psoriasis
Psoriasis, a chronic, immune-mediated disease that results from the
overproduction of skin cells, affects 125 million people worldwide, including
nearly 7.5 million Americans.[1] Plaque psoriasis often results in patches of
thick, red or inflamed skin covered with silvery scales known as
plaques.These plaques can crack and bleed, and may occur anywhere on the
body.[2]The disease symptoms can range from mild, to moderate, to severe and
disabling. It is estimated that nearly three percent of the world's
population is living with psoriasis and nearly one-quarter of those people
have cases that are considered moderate to severe.[1]

About Janssen Research & Development, LLC
At Janssen, we are dedicated to addressing and solving some of the most
important unmet medical needs of our time in oncology, immunology,
neuroscience, infectious diseases and vaccines, and cardiovascular and
metabolic diseases. Driven by our commitment to patients, we develop
innovative products, services and healthcare solutions to help people with
serious diseases throughout the world. Beyond its innovative medicines,
Janssen is at the forefront of developing education and public policy
initiatives to ensure patients and their families, caregivers, advocates and
healthcare professionals have access to the latest treatment information,
support services and quality care.

Janssen Research & Development, LLC  is one of the Janssen Pharmaceutical
Companies of Johnson & Johnson. Please visit www.janssen.com for more
information. Follow us on Twitter at www.twitter.com/JanssenUS.

(This press release contains "forward-looking statements" as defined in the
Private Securities Litigation Reform Act of 1995, including regarding plans
for further clinical development of guselkumab. 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 expectations and projections of Janssen Research &
Development, LLC or Johnson & Johnson. Risks and uncertainties include, but
are not limited to, technological advances, new products and patents attained
by competitors; challenges and difficulties inherent in new product
development, including obtaining regulatory approvals; manufacturing
difficulties or delays; and trends toward health care cost containment. A
further list and description of 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 29, 2013 and in its subsequent reports on Form 10-Q
and Form 8-K. Copies of these filings are available online at www.sec.gov,
www.jnj.com or on request from Johnson & Johnson. None of the Janssen
Pharmaceutical Companies or Johnson & Johnson undertakes to update any
forward-looking statements as a result of new information or future events or
developments.)

References

1.National Psoriasis Foundation. About Psoriasis: Statistics.
    http://www.psoriasis.org/learn_statistics. Accessed December 11, 2013.
2.National Psoriasis Foundation. About Psoriasis.
    http://psoriasis.org/about-psoriasis. Accessed December 11, 2013.

SOURCE Janssen Research & Development, LLC

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