Abstract
Psoriasis is an autoimmune skin disease affecting patients’ daily lives significantly. To incorporate patient perspectives, patient-reported outcomes (PROs) have been widely used for treatment decision-making in patients with psoriasis. However, it is unclear whether the PROs are consistently reported in different drug information sources. This study examined the PRO data reporting in psoriasis drugs’ pivotal trials by comparing Food and Drug Administration (FDA) labeling, FDA medical reviews, and trial publications. We included new molecular entities (NMEs) and biologic license applications (BLAs) initially approved by the FDA for psoriasis and/or psoriatic arthritis between 1/1/2006 and 12/31/2019. Product labeling and medical reviews of included drugs were collected from [email protected] (the FDA-approved drugs database) and examined details on PRO measures used in pivotal trials and the trials’ design. Using the identified trial design, trial registrations at ClinicalTrials.gov (the National Library of Medicine’s trial registry) were searched, and the list of publications was obtained. From the list, we identified matching trial publications by excluding review articles and duplicates, and the reporting of PRO measures were investigated. Data were extracted by two authors independently, and discrepancies were resolved through discussion. Of nine drugs indicated for psoriasis and/or psoriatic arthritis, seven (78%) of their product labeling contained information about five unique PRO measures. However, all of their FDA medical reviews included information about 14 unique PRO measures used in 21 pivotal trials. From ClinicalTrials.gov, 53 matching trial publications were identified, and 34 (64%) contained information about 13 unique PRO measures. Five drugs had discrepancies in reported PRO measures between FDA medical reviews and trial publications. PRO measures were inconsistently reported in psoriasis drugs’ product labeling, FDA medical reviews, and trial publications. Further investigation is warranted to explore the reasons behind such an inconsistent reporting of PRO measures among different drug information sources.
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