A standardization approach to compare treatment safety and effectiveness outcomes between clinical trials and real-world populations in psoriasis.

ABSTRACT:

Background

Patients recruited in randomized controlled trials (RCTs) for biologic therapies in psoriasis are not fully representative of the real-world psoriasis population.

Objectives

Firstly, to investigate whether patient characteristics are associated with being included in a psoriasis RCT. Secondly, to estimate the differences in the incidence of severe adverse events (SAEs) and the response rate between RCT and real-world populations of patients on biologic therapies for psoriasis using a standardization method.

Methods

Data from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR) were appended to individual participant-level data from two RCTs assessing ustekinumab in patients with psoriasis. Baseline variables were assess

SUBMITTER: Yiu ZZN 

PROVIDER: S-EPMC6916305 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature