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.2The 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.5In 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.8
“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
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 European Medicines Agency. Stelara Summary of Product Characteristics. Available at:www.ema.europa.eu/en/documents/product-information/stelara-epar-product-information_en.pdf.