Psoriasis
Conditions
Brief summary
Prospective, Observational Study to Assess the Long-Term Safety of Brodalumab Compared with Other Therapies in the Treatment of Adults with Moderate-to-Severe Psoriasis
Detailed description
Prospective, Observational Study to Assess the Long-Term Safety of Brodalumab Compared with Other Therapies in the Treatment of Adults with Moderate-to-Severe Psoriasis Who Are Candidates for Systemic Therapy or Phototherapy in the Course of Actual Clinical Care
Interventions
Brodalumab
Comparator subjects treated with non-biologic IL-17 inhibitors
Sponsors
Study design
Eligibility
Inclusion criteria
1. Diagnosis and main criteria for inclusion: a subject must have moderate to severe psoriasis diagnosed by a dermatologist 2. Must be at least 18 years of age or older 3. Started on or switched to a systemic psoriasis treatment within the previous 12 months. FDA-approved biologic treatments and select non-biologic treatments (eg, methotrexate, cyclosporine, or apremilast only) are permitted.
Exclusion criteria
1. The subject is unable or unwilling to provide informed consent to participate in the registry. 2. The subject is participating or planning to participate in a clinical trial with a non-marketed or marketed investigational drug (i.e. Phase I-IV drug trial). 3. The subject is restarting the eligible medication less than 12 months since receiving the last dose.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the incidence of malignancy | 8 years | Assess the incidence of malignancy, excluding non-melanoma skin cancer (NMSC), in adult psoriasis subjects exposed to brodalumab in the course of actual clinical care compared to non-IL-17-inhibitor biologic medications used to treat psoriasis. |
Countries
United States