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This study analyzes the reporting of adverse events in psoriasis-related randomized controlled trials to evaluate their completeness and quality.

March 2, 2026Open Access

Reporting of the harms from randomized controlled trials for psoriasis: a cross-sectional meta-epidemiological study

Key Points

This study analyzes the reporting of adverse events in psoriasis-related randomized controlled trials to evaluate their completeness and quality.
Conducted a cross-sectional meta-epidemiological study.
Performed a comprehensive search of PubMed and Cochrane databases for relevant trials from 2020 to 2025.
Included randomized controlled trials specifically investigating non-articular psoriasis while excluding long-term extension studies.
Assessed the Adverse Event Reporting Completeness Index (AERCI) for reporting quality.
Included a total of 187 psoriasis RCTs published between 2020 and 2025.
The median AERCI-Core score was 6.00, indicating suboptimal reporting quality with only 26.2% rated high quality.
Low reporting adherence was noted for key areas such as AE management (16.0%) and timing of AE onset (20.3%).
Higher journal impact factor and a focus on pustular psoriasis subtype were positively associated with better reporting completeness.

Abstract

Objectives Analysis of adverse events (AEs) in randomized controlled trials (RCTs) related to psoriasis. Design A cross-sectional meta-epidemiological study. Data sources We conducted a comprehensive search of PubMed and the Cochrane Database for studies meeting our eligibility criteria from January 2020 to July 2025. Eligibility criteria RCTs 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 measures We 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. Results A 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. Conclusions This 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.

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