A 10-Year, Post-marketing, Observational Study to Assess Long Term Safety of HUMIRA® (Adalimumab) in Adult Patients With Chronic Plaque Psoriasis (PS) (ESPRIT)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective Observational Study

Study drug and medical condition

• Name of medicine:
  HUMIRA
• Study drug International non-proprietary name (INN) or common name:
  ADALIMUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AB04) adalimumab

  adalimumab
• Medical condition to be studied:
  Psoriasis
• Additional medical condition(s):
  Chronic Plaque Psoriasis

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  6082

Study design details

• Main study objective:
  The primary objective of this registry is to evaluate the long-term safety of HUMIRA® inadult Ps patients who are treated as recommended in the product label.
• Outcomes:
  - Incidence of Serious Adverse Events-Incidence of Adverse Events of Special Interest ; - Adverse Events that lead to permanent discontinuation of HUMIRA®, ; - Health Care Utilization-Work Productivity and Activity Impairment Questionnaire: Specific Health Problem-Patient Global Assessment; - Patient Health Question-9; - Medical Outcomes Social Activities Scale; - Patient reported outcome; - Census-Psoriasis Impact and Experience; - Illness Cognition; - Insurance Status; - Rosenberg Self-Esteem Scale-Physician's Global Assessment
• Data analysis plan:
  The number and percent of patients experiencing SAEs, AEs of Special Interest and AEsthat lead to permanent discontinuation of HUMIRA® during the registry, regardless ofwhether the AEs are reported during or after the HUMIRA® treatment, will be tabulatedby body system and Medical Dictionary for Drug Regulatory Activities (MedDRA) preferred term. Rates (event per 100 patient-year of observation) of SAEs and AEs ofSpecial Interest and the 95% confidence interval will be provided. The analysis will beperformed using data from first day in the registry to the date of last contact for the AllTreated Patient Population. The last contact date is defined as the last date of registry ordirect to HCP process participation, whichever occurs later. Standardized incidence ratios(SIRs) will be used to compare the rates of events in this registry to the general population.

Documents

Study report

P10-023-CSR Abstract_Redacted