17 June 2019 - - US-based healthcare company Johnson and Johnson's (NYSE: JNJ) The Janssen Pharmaceutical Companies business has presented new data 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, the company said.
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.
The PsABio study is investigating the impact of achieving low disease activity in the key characteristics of PsA i.e. skin and joint inflammation.
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 or remission, after six months of treatment.
Furthermore, these outcomes were shown to be associated with improved health-related quality of life (HRQoL), better physical functioning and reduced pain.
Beyond skin and joints, PsA patients are often affected by co-morbidities such as obesity.
A further analysis from PsABio looked at the impact of obesity on PsA disease activity at study baseline.
This relationship was investigated in 917 patients with PsA taking either ustekinumab or TNFi.
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 outcomes and more severe disease activity.
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.
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.
It is estimated that up to 42% of the 14m people who are living with psoriasis in Europe will also develop psoriatic arthritis which causes pain, stiffness and swelling in and around the joints.
The PsABio study (NCT no. NCT02627768 / CNTO1275PSA4003) is an on-going, prospective, observational, cohort study, being conducted in eight European countries, assessing the efficacy, tolerability and persistence of ustekinumab and TNFi for patients with PsA starting 1st, 2nd or 3rd line biologic disease-modifying antirheumatic drugs (bDMARDs) in real-world routine care.
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.
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 5/7 criteria (data available for 206 and 260 patients, respectively).
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).
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%).
The other 5 components were all missed with equal frequency. Available observed data on univariate associations were presented, with no imputation of missing data or adjustment for baseline imbalances.
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.
Results at six 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.
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.
Baseline data of the study population were collected and analysed for body mass index, disease activity (cDAPSA, psoriasis, BSA), patient-perceived impact (PsAID-12), disability (HAQ-DI) and presence or history of CVD/MET (cardiovascular disease/metabolic equivalent).
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.