Data Sheet 1_Reporting of the harms from randomized controlled trials for psoriasis: a cross-sectional meta-epidemiological study.docx

ObjectivesAnalysis of adverse events (AEs) in randomized controlled trials (RCTs) related to psoriasis.
DesignA cross-sectional meta-epidemiological study.
Data sourcesWe conducted a comprehensive search of PubMed and the Cochrane Database for studies meeting our eligibility criteria from January 2020 to July 2025.
Eligibility criteriaRCTs specifically investigating non-articular psoriasis were included. All long-term extension (LTE) studies were excluded; however, psoriasis-related RCTs utilizing both double-blind and open-label designs were incorporated.
Main outcome measuresWe assessed (1) general characteristics of psoriasis RCTs; (2) the Adverse Event Reporting Completeness Index (AERCI) Score for reporting completeness; (3) specific details of AEs; (4) factors associated with reporting completeness.
ResultsA total of 187 psoriasis RCTs published between 2020 and 2025 were included. The median AERCI-Core score was 6.00 (IQR: 2.00–8.00), indicating suboptimal overall reporting quality, with only 26.2% of studies rated as high quality. Adherence to individual reporting items varied widely, with particularly low rates observed for AE management measures (16.0%), timing of AE onset (20.3%), outcome/resolution (26.7%), and use of standardized coding systems (31.6%). Multivariable linear regression identified journal impact factor [β = 0.27, 95% CI (0.13, 0.40), P < 0.001] and pustular psoriasis subtype [β = 1.85, 95% CI (0.10, 3.60), P = 0.038] as independent predictors of higher reporting completeness.
ConclusionsThis study identified inadequate reporting of adverse events in RCTs for non-articular psoriasis. After adjusting for confounding variables, a higher journal impact factor and a focus on pustular psoriasis were positively associated with the complete reporting of AEs. To enhance the utility of safety data for clinical decision-making, future trials should rigorously implement the Consolidated Standards of Reporting Trials—Harms 2022 (CONSORT-Harms 2022) recommendations, thereby providing patients with more balanced information on the benefits and harms of psoriasis therapies.