JANSSEN

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 ustekinumab ¹⁰

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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Contact:

Media contacts: Emily Bone +44 1494 658 892 ebone1@its.jnj.com Investor contacts: Christopher DelOrefice Johnson & Johnson +1 732 524 2955 Lesley Fishman Johnson & Johnson +1 732 524 3922