INTRODUCTION
Psoriasis is a chronic dermatologic disease that affects more than 7.4 million individuals in the United States (US).1 Biologic therapies targeting inflammatory cytokines have become an important treatment option for patients with moderate-to-severe psoriasis.2 Several biologics that inhibit interleukin 17 (IL-17) or IL-23 have recently been approved in this indication by the Food and Drug Administration (FDA), as these cytokines are integral to the pathogenesis of psoriasis.3,4 Guselkumab (CNTO 1959; Janssen Research & Development LLC, Spring House, PA), a novel human monoclonal antibody that inhibits IL-23, was the first biologic of its class approved by the FDA for the treatment of adult patients with moderate-to- severe plaque psoriasis.5,6
Describing the baseline characteristics of patients who are initiating a recently approved therapy is important to provide insights regarding variables that may impact observed treatment outcomes, which may ultimately play a role in treatment decision making. However, the characteristics of patients with psoriasis initiating treatment with guselkumab in a real-world setting are not well characterized. The objective of the present study was to describe the baseline characteristics and treatment history of patients with psoriasis who initiated guselkumab during the first year after FDA approval using real- world data from the Symphony Health Claims database.
Describing the baseline characteristics of patients who are initiating a recently approved therapy is important to provide insights regarding variables that may impact observed treatment outcomes, which may ultimately play a role in treatment decision making. However, the characteristics of patients with psoriasis initiating treatment with guselkumab in a real-world setting are not well characterized. The objective of the present study was to describe the baseline characteristics and treatment history of patients with psoriasis who initiated guselkumab during the first year after FDA approval using real- world data from the Symphony Health Claims database.
MATERIALS AND METHODS
Patient Population
A retrospective, descriptive analysis was conducted using data from the Symphony Health Claims database. This database includes US pharmacy, diagnosis, and procedure claims collected through electronic claims processors, commercial sources, and government sources (Medicare and Medicaid). Over 93% of outpatient prescriptions dispensed in the US and territories are captured in this database.7 Furthermore, the Symphony database is built around claims processors and therefore approximates “real-time†data, allowing for evaluation relatively soon after product approval.
The present study included patients with psoriasis aged 18 years or greater who had ≥2 psoriasis diagnoses separated by at least 30 days between 10/01/2012 and 08/31/2018. Patients were included if they had ≥1 claim for guselkumab between 7/13/2017 (the FDA approval date for guselkumab in psoriasis) and 7/2/2018. The index date was defined as the date of the first pharmacy claim for guselkumab and the baseline period was defined as the 365-day period prior to the index date. Patients were excluded if they had claims for >1 biologic on the index date or if they had claims with potential day supply problems or out-of-range/uninterpretable quantities.
A retrospective, descriptive analysis was conducted using data from the Symphony Health Claims database. This database includes US pharmacy, diagnosis, and procedure claims collected through electronic claims processors, commercial sources, and government sources (Medicare and Medicaid). Over 93% of outpatient prescriptions dispensed in the US and territories are captured in this database.7 Furthermore, the Symphony database is built around claims processors and therefore approximates “real-time†data, allowing for evaluation relatively soon after product approval.
The present study included patients with psoriasis aged 18 years or greater who had ≥2 psoriasis diagnoses separated by at least 30 days between 10/01/2012 and 08/31/2018. Patients were included if they had ≥1 claim for guselkumab between 7/13/2017 (the FDA approval date for guselkumab in psoriasis) and 7/2/2018. The index date was defined as the date of the first pharmacy claim for guselkumab and the baseline period was defined as the 365-day period prior to the index date. Patients were excluded if they had claims for >1 biologic on the index date or if they had claims with potential day supply problems or out-of-range/uninterpretable quantities.
