ORIGINAL RESEARCH article
Front. Med.
Sec. Dermatology
Reporting of the harms from Randomized Controlled Trials for Psoriasis: A cross-sectional meta-epidemiological study
Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China
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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.
Summary
Keywords
A methodologicalstudy, adverse events, CONSORT-Harms, Psoriasis, randomized controlled trials
Received
28 October 2025
Accepted
03 February 2026
Copyright
© 2026 Yang, Yalan, Shen, Cheng, Dai, Hao and Hu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
*Correspondence: Zhipeng Hu
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