Efficacy and Safety of Integrated Traditional Chinese Medicine and Biologic Treatment in Moderate to Severe Atopic Dermatitis: Protocol for a Prospective Observational Real-World Study.

Background: Atopic dermatitis (AD) is a chronic and relapsing skin disorder that significantly impairs patients' quality of life. Long-term biologic therapy provides durable efficacy for AD, but raises concerns related to costs, safety, and withdrawal-associated relapse. Traditional Chinese medicine (TCM) has a long history in AD treatment and is usually integrated with biologic treatment to achieve complementary benefits and provide comprehensive care for patients with AD. However, high-quality evidence supporting its real-world efficacy remains limited. Objective: This study aims to collect real-world data to evaluate the efficacy and safety of TCM integrated with biologics (TCMIB) in moderate to severe AD, thereby providing methodological insights to obtain high-quality evidence and inform future in-depth research on AD treatment. Methods: A total of 3500 patients with moderate to severe AD will be classified into 7 groups based on clinical manifestations and receive 16 weeks of treatment followed by 36 weeks of observation. A reduction of 75% or more in eczema area and severity index score from baseline to week 16 is set as the primary outcome. The secondary outcomes include the eczema area and severity index, body surface area, Investigator's Global Assessment scale, Dermatology Life Quality Index, numerical rating scale for pruritus, Patient-Oriented Eczema Measure, Atopic Dermatitis Control Tool, and TCM syndrome scale. Assessments will be performed at baseline, every 2 weeks until week 16, and then every 4 weeks until week 52. Safety assessments include vital signs, concomitant medications, and adverse events. The SAS software (version 9.4) will be used for data analysis, and a P value of less than .05 will be considered statistically significant. Results: This study has been approved by the institutional review boards of Shanghai Skin Disease Hospital and registered on the International Traditional Medicine Clinical Trial Registry (ITMCTR2025000984). Patient recruitment began in June 2025 and is expected to be completed in January 2028. Data analysis will begin in June 2028. The main results of the study are expected to be submitted for publication in peer-reviewed journals in December 2028. Conclusions: The anticipated findings of this protocol are projected to furnish strong evidence on the efficacy and safety of TCMIB for moderate to severe AD, potentially contributing to the standardization of TCMIB and optimization of clinical practice.