Janssen presents new real-world evidence at the Annual European Congress of Rheumatology (EULAR 2019) which suggests that effective PsA treatment should target more than skin and joints

MADRID–(BUSINESS WIRE)–The Janssen Pharmaceutical Companies of Johnson & Johnson presented new
data this week from PsABio – its ongoing, real-world study of nearly
1,000 people with psoriatic arthritis, who have started treatment with
either Stelara (ustekinumab) or a Tumour Necrosis Factor inhibitor
(TNFi).¹ This important data was presented at this year’s
Annual European Congress of Rheumatology (EULAR 2019) in Madrid, Spain.

PsA is a challenging and multi-faceted immune-mediated inflammatory
disease affecting multiple sites in the body, for example, the skin,
joints and soft tissue. Furthermore, co-morbidities such as obesity,
cardiovascular disease and metabolic syndrome, are often associated with
PsA.²

The PsABio study is investigating the impact of achieving low disease
activity in the key characteristics of PsA i.e. skin and joint
inflammation.³ The results presented from the analysis showed
that treatment with either ustekinumab or TNFi’s leads to considerable
and comparable numbers of patients reaching low disease activity (LDA)
or remission, after six months of treatment.³ Furthermore,
these outcomes were shown to be associated with improved health-related
quality of life (HRQoL), better physical functioning and reduced pain.^3,4

“The many disease manifestations caused by PsA profoundly affect
patients’ quality of life, ability to function and experience of pain.
For their burden of disease to be reduced, treatment strategies should
address all these disease symptoms,” commented Laure Gossec, Primary
Investigator of the PsABio study and Professor of Rheumatology at
Pitie-Salpétriere Hospital and Sorbonne Université, Paris, France. She
continued, “Our data therefore support a treat-to-target strategy in
routine care of PsA to ensure patients achieve remission or low-disease
activity and an improved health-related quality of life.”

Beyond skin and joints, PsA patients are often affected by
co-morbidities such as obesity.² A further analysis from
PsABio looked at the impact of obesity on PsA disease activity at study
baseline.⁵ This relationship was investigated in 917 patients
with PsA taking either ustekinumab or TNFi.⁵ Results
demonstrated that obesity was linked to a high disease activity at
baseline in terms of physician-reported and patient-reported outcomes,
level of skin involvement (body surface area) and physical function
(HAQ) outcomes and more severe disease activity.⁵ In a
multivariate analysis, higher BMI was independently linked to higher PsA
disease activity, disease impact and impaired functioning. As obesity is
common in patients with PsA, these results highlight the need for
lifestyle-directed approaches in treating PsA, such as weight management
in parallel with joint- and skin-focused treatment.^2,5

The common (≥1/100) adverse reactions reported in controlled periods of
the adult psoriasis, psoriatic arthritis and Crohn’s disease clinical
studies with ustekinumab as well as post-marketing experience were:
upper respiratory tract infection, arthralgia, back pain, diarrhoea,
dizziness, fatigue, headache, infection site pain, injection site
erythema, myalgia, nasopharyngitis, nausea, oropharyngeal pain, pruritus
and vomiting.¹⁰

“At Janssen, we understand the value of providing ‘real-world’ data
to the medical community and we are pleased that the PsABio study will
help to answer some important questions regarding the optimal management
of people with PsA in everyday clinical practice,” commented Dr
Jaime Oliver, Therapeutic Area Lead, Immunology and CVT, Europe Middle
East & Africa, Janssen Cilag GmbH International. “As the PsABio
study continues to gather more real-world data, we will share further
insights to help improve the lives of patients with PsA.”

It is estimated that up to 42 percent of the 14 million people who are
living with psoriasis in Europe will also develop psoriatic arthritis
which causes pain, stiffness and swelling in and around the joints.^6,7

ENDS

About the PsABio Study

The PsABio study (NCT no. NCT02627768
/ CNTO1275PSA4003) is an on-going, prospective, observational, cohort
study, being conducted in 8 European countries, assessing the efficacy,
tolerability and persistence of ustekinumab and TNFi for patients with
PsA starting 1^st, 2^nd or 3^rd line
biologic disease-modifying antirheumatic drugs (bDMARDs) in real-world
routine care.¹

In the Gossec et al. abstract showing LDA analysis and the
‘treat-to-target’ strategy, of the 563 ustekinumab or TNFi-treated
patients enrolled between Dec 2015–Aug 2017, 303 had data available from
their 6-month follow-up.³ Disease states were defined using
the Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) ≤4
for remission and ≤13 for LDA (data available for 250 patients) and VLDA
(Very Low Disease Activity) 7/7 and minimal disease activity (MDA) 5/7
criteria (data available for 206 and 260 patients, respectively).³
HRQoL was assessed by the generic instrument, EQ5D, and the PsA specific
tool, PsAID-12. Physical functioning was measured by the Health
Assessment Questionnaire without Disability Index (HAQ-DI) and pain
measured with a Pain VAS (Visual Analog Scale) (0-100).³
Assessment of Psoriasis Skin Disease (68/299=22.7%) was the most
frequently missed MDA component, while enthesitis was the least
frequently missed (6/299=2.0%).³ The other 5 components were
all missed with equal frequency (8-9%). Available observed data on
univariate associations were presented, with no imputation of missing
data or adjustment for baseline imbalances.³

For the 303 patients, mean age was 49.7 (standard deviation [SD] 12.8)
years, mean disease duration was 7.2 (SD, 8.2) years, and 50.5% were
women.³ Results at 6 months showed approximately equal rates
of cDAPSA remission, cDAPSA LDA, MDA and VLDA with both ustekinumab and
TNFi’s. cDAPSA remission/LDA and VLDA/MDA achievement in both treatment
groups was associated with improved general and disease-specific
health-related quality of life (HRQoL) assessments (EQ5D VAS, PsAID-12),
physical functioning (HAQ-DI) and pain (VAS).^3,4

A second analysis reported by Siebert et al. investigated the
relationship between baseline overweight/obesity and disease activity,
patient-reported outcomes and disability in a large real-world cohort of
patients with PsA starting biologic treatment with either ustekinumab or
TNFi.⁵ Baseline data of the study population were collected
and analysed for body mass index (BMI), disease activity (cDAPSA,
psoriasis, BSA), patient-perceived impact (PsAID-12), disability
(HAQ-DI) and presence or history of CVD/MET (cardiovascular
disease/metabolic equivalent).⁵ Descriptive statistics of
available data and three exploratory multiple regression models were
described, to investigate the relationship of cDAPSA, PsAID-12 and
HAQ-DI (dependent variables) with BMI, adjusted for age, sex, smoking,
body surface area, c-reactive protein, disease duration and biologic
treatment.⁵

About psoriatic arthritis

Psoriatic arthritis is a chronic, immune-mediated inflammatory disease
characterised by both joint inflammation and the skin lesions associated
with psoriasis.⁸ The disease causes pain, stiffness and
swelling in and around the joints and commonly appears between the ages
of 30 and 50, but can develop at any time.⁹ Although the
exact cause of psoriatic arthritis is unknown, genes, the immune system
and environmental factors are all believed to play a role in disease
onset.⁹

About ustekinumab¹⁰

In the European Union, ustekinumab is approved for the treatment of
moderate to severe plaque psoriasis in adults who failed to respond to,
or who have a contraindication to, or are intolerant to other systemic
therapies including ciclosporin, methotrexate or psoralen plus
ultraviolet A (PUVA), and is also indicated for the treatment of
moderate to severe plaque psoriasis in adolescent patients from the age
of 12 years and older who are inadequately controlled by or are
intolerant to other systemic therapies or phototherapies. In addition,
ustekinumab is approved alone or in combination with MTX for the
treatment of active psoriatic arthritis in adult patients when the
response to previous non-biological disease-modifying antirheumatic drug
(DMARD) therapy has been inadequate. Ustekinumab is approved by the
European Commission for the treatment of adult patients with moderately
to severely active Crohn’s disease who have had an inadequate response
with, lost response to, or were intolerant to either conventional
therapy or a TNF-alpha antagonist or have medical contraindications to
such therapies.

The common (≥1/100) adverse reactions reported in controlled periods of
the adult psoriasis, psoriatic arthritis and Crohn’s disease clinical
studies with ustekinumab as well as post-marketing experience were:
upper respiratory tract infection, arthralgia, back pain, diarrhoea,
dizziness, fatigue, headache, infection site pain, injection site
erythema, myalgia, nasopharyngitis, nausea, oropharyngeal pain, pruritus
and vomiting.

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain
exclusive worldwide marketing rights to ustekinumab, which is currently
approved for the treatment of moderate to severe plaque psoriasis in 89
countries, paediatric psoriasis in 44 countries, psoriatic arthritis in
83 countries and Crohn’s disease in 70 countries.

Stelara^® (ustekinumab) is a registered trademark of Johnson &
Johnson.

Important Safety Information

For complete European Union (EU) prescribing information, please visit: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000958/WC500058513.pdf.

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, we’re creating a future where disease is a thing of the
past. We’re the Pharmaceutical Companies of Johnson & Johnson, working
tirelessly to make that future a reality for patients everywhere by
fighting sickness with science, improving access with ingenuity, and
healing hopelessness with heart. We focus on areas of medicine where we
can make the biggest difference: Cardiovascular & Metabolism,
Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and
Pulmonary Hypertension.

Learn more at www.janssen.com/EMEA.
Follow us at www.twitter.com/JanssenEMEA.
Janssen Cilag International NV and Janssen Cilag GmbH International are
part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in
the Private Securities Litigation Reform Act of 1995 regarding
development of ustekinumab in psoriatic arthritis. The reader is
cautioned not to rely on these forward-looking statements. These
statements are based on current expectations of future events. If
underlying assumptions prove inaccurate or known or unknown risks or
uncertainties materialize, actual results could vary materially from the
expectations and projections of any of the other Janssen Pharmaceutical
Companies and/or Johnson & Johnson. Risks and uncertainties include, but
are not limited to: challenges and uncertainties inherent in product
research and development, including the uncertainty of clinical success
and of obtaining regulatory approvals; uncertainty of commercial
success; manufacturing difficulties and delays; competition, including
technological advances, new products and patents attained by
competitors; challenges to patents; product efficacy or safety concerns
resulting in product recalls or regulatory action; changes in behavior
and spending patterns of purchasers of health care products and
services; changes to applicable laws and regulations, including global
health care reforms; and trends toward health care cost containment. A
further list and descriptions of these risks, uncertainties and other
factors can be found in Johnson & Johnson’s Annual Report on Form 10-K
for the fiscal year ended December 30, 2018, including in the sections
captioned “Cautionary Note Regarding Forward-Looking Statements” and
“Item 1A. Risk Factors,” and in the company’s most recently filed
Quarterly Report on Form 10-Q, and the company’s subsequent filings with
the Securities and Exchange Commission. 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 nor Johnson & Johnson undertakes to update any forward-looking
statement as a result of new information or future events or
developments.

References

¹ ClinicalTrials.gov. A Study on Assessment of STELARA and
Tumor Necrosis Factor Alpha Inhibitor Therapies in Participants with
Psoriatic Arthritis (PsABio). Available at: https://clinicaltrials.gov/ct2/show/NCT02627768.
Last accessed June 2019.
² Haddad A., et al
(2017) Comorbidities in Patients with Psoriatic Arthritis. Rambam
Maimonides Med J;8(1):e0004.
³ Gossec L., et al (2019)
Achieving the treatment targets of remission or low disease activity
(LDA) in Psoriatic Arthritis (PsA) is associated with significantly
improved quality of life, function and pain. Abstract at Annual European
Congress of Rheumatology (EULAR 2019), Madrid, Spain.
⁴
Smolen J.S., et al (2015) Disease activity and response
assessment in psoriatic arthritis using the Disease Activity index for
PSoriatic Arthritis (DAPSA). A brief review. Clin Exp Rheaumatol;33(Suppl.93):S48-S50.
⁵
Siebert S, et al (2019) High body mass index (BMI) in psoriatic
arthritis (PsA) is associated with higher disease activity in joints and
skin, impaired quality of life and more disability: Results from the
PsABio study. Abstract at Annual European Congress of Rheumatology
(EULAR 2019), Madrid, Spain.
⁶ Gladman D.D et al (2005)
Psoriatic arthritis: epidemiology, clinical features, course,and
outcome. Ann Rheum Dis;64(Suppl II): :ii14–ii17.
⁷
Ortonne J.P. et al (2004) Alefacept: a novel and selective
biologic agent for the treatment of chronic plaque psoriasis. European
Journal of Dermatology;14:41–45.
⁸ Arthritis
Research UK. Psoriatic Arthritis. Available at: www.arthritisresearchuk.org/arthritis-information/conditions/psoriatic-arthritis.aspx.
Last accessed June 2019.
⁹ National Psoriasis
Foundation. About Psoriatic Arthritis. Available at: www.psoriasis.org/psoriatic-arthritis.
Last accessed June 2019.
¹⁰ European Medicines Agency.
Stelara Summary of Product Characteristics. Available at: www.ema.europa.eu/en/documents/product-information/stelara-epar-product-information_en.pdf.
Last accessed June 2019.

CP-95187
June 2019

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