Observational Study to Estimate the Effectiveness of Biologics When Treating Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Observational

Summary: 
      To estimate the real-world effectiveness of approved biologics in subjects with
      moderate-to-severe plaque psoriasis who are either starting or switching biologic medication.
    

Detailed description: 
      Plaque psoriasis is a chronic skin disease affecting 1-3% of US and European populations and
      severely impairs quality of life. Four biologics are authorized in Europe and the US for
      treatment of patients with moderate to severe psoriasis. Because complete skin clearance is
      rare with these agents, the treatment goal adopted by regulatory and reimbursement agencies
      is the proportion of patients achieving at least a 75% reduction from the subject's baseline
      PASI (Psoriasis Area and Severity Index) score or similarly, a sPGA [static Physician's
      Global Assessment) score of 0 or 1. Specifically, this study will provide information on the
      effectiveness of approved biologics as they are used in clinical practice. This information
      is currently not consistently available from other sources, including existing psoriasis
      patient registries.

      Study Hypothesis: This study will estimate in each country the proportion of biologic
      treatment-naïve and biologic treatment-switching psoriasis subjects in the real-world having
      total clearance at 6 months after initiating a biologic.

      The study population will include up to approximately 300 adults in each of up to 6
      participating countries who have been diagnosed by their physicians with moderate to severe
      plaque psoriasis, and are initiating biologic therapy(biologic treatment-naïve or biologic
      treatment-switching) for plaque psoriasis.

      Summary of Subject Eligibility Criteria: aged 18 or over; diagnosed with moderate to severe
      plaque psoriasis; initiating a biologic approved for psoriasis at study entry; able to fill
      out questionnaires; provided written informed consent; and not participating in a clinical
      trial utilizing an investigational agent in the 3 months prior to the first biologic dose.

      Assessments: Skin clearance is the primary indicator of treatment effectiveness, and will be
      measured using the physician-reported PASI and sPGA. Other assessments will be by the
      following patient questionnaires: psoriasis symptom inventory (PSI), the dermatology life
      quality index (DLQI), the static patient's global assessment ( sPtGA), treatment satisfaction
      and global health status.

      All subjects will be initiating biologic therapy at study entry. Therapy discontinuations,
      switches, and dosing changes during follow-up will be reported by the site and summarized.

      Follow-up continues for approximately 12 months after first dose or until the subject is lost
      to follow-up or withdraws from the study (for any reason including death), whichever comes
      first. Where appropriate, data will be obtained for each subject during mandatory visits at 6
      months (± 6 weeks) and 12 months (± 6 weeks) after first biologic dose, and at routine visits
      that occur during the follow-up period. To the extent possible data will also be collected at
      other usual care visits that occur during follow-up.
    

Intervention name(s): NIS
Intervention type(s): Other
Intervention description(s): This is a non-interventional study (NIS) of usual care over the 12 months following initiation of biologic therapy.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults greater than or equal to 18 years of age who have been diagnosed with moderate to
        severe plaque psoriasis based on treating physician's judgment
      
Keywords: Dermatology, plaque psoriasis, biologic treatment, biologic naive