Psoriasis Longitudinal Assessment and Registry (PSOLAR)

Primary Outcome Measures:

• Number of patients with Adverse Events and Serious Adverse Events [ Time Frame: 8 years from last patient enrolled ]
  An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. All adverse events, including those of special interest, such as dysplasias and malignancies of all types, serious infections, and new autoimmune disease, will be documented.
  
  

Secondary Outcome Measures:

• Physician reported plaque psoriasis and psoriatic arthritis (PsA) Score [ Time Frame: every 6 months for 8 years ]
  
• Dermatology Life Quality Index (DLQI) Score [ Time Frame: every 6 months for 8 years ]
  
• EuroQOL quality of life assessment [ Time Frame: every 6 months for 8 years ]
  
• Hospital Anxiety and Depression Scale (HADS) Score [ Time Frame: every 6 months up to Month 18 and then every year up to 8 years ]
  
• Percentage of patients being treated that meets labeling criteria [ Time Frame: every 6 months for 8 years ]
  
• Percentage of participants with comorbidities: cardiovascular disease [ Time Frame: Day 1 ]
  
• Percentage of participants with comorbidities: malignancy [ Time Frame: Day 1 ]
  
• Burden of Disease: Body surface area [ Time Frame: every 6 months for 8 years ]
  
• Burden of Disease: Psoriasis Area and Severity Index (PASI) Score [ Time Frame: every 6 months for 8 years ]
  
• Evaluation of disease features: Physicians global assessment of disease activity (PGA) Score [ Time Frame: every 6 months for 8 years ]
  

PSOLAR is an 8 year registry study. A registry is an observational study that evaluates the status of a disease. This registry study will only include patients who volunteer to take part. About 2000 infliximab-exposed patients and 4000 ustekinumab-exposed patients as well as a comparable number of patients (4000) on other standard of care psoriasis therapies (e.g. Etanercept) and/or psoriasis treatments (e.g. topical or light therapy treatments) will take part in the registry study, internationally. The Registry does not require any study-specific testing, but may capture test information (e.g. laboratory tests, X-rays) that are collected as part of normal routine care for the registry program. Patient information will be collected at the enrollment visit and about every 6 months thereafter. At enrollment, information on demographics (e.g. gender, race, date of birth), medical history and family medical history, details of past and current psoriasis treatments (e.g. infliximab and standard therapy), and current medication regimens will be collected. Clinical follow-up will be based on observations from physical examination, clinical disease status, Quality of Life assessment (e.g. Dermatology Life Quality Index, Hospital Anxiety and Depression Scale, EQ-5D (EuroQoL-5D is a Quality of Life Questionnaire) Health Questionnaire Scale, Employment/Productivity Health Economic Questionnaire), current medications, and any adverse events/problems reported. During each six -month follow-up visit with the study doctor, information collected will include observations from physical examination, updates on clinical disease status, Quality of life assessments, medications and adverse events/problems. No study agents will be administered in this registry. All patients will receive standard of care treatments prescribed by the patient's physician.