[Translated article] BIOBADATOP Spanish Atopic Dermatitis Registry: Description and Early Findings

Area of Science:

• Dermatology
• Clinical Pharmacology
• Real-World Evidence

Background:

• Atopic dermatitis (AD) understanding has advanced, necessitating real-world clinical data.
• The Spanish Atopic Dermatitis Registry (BIOBADATOP) collects prospective data on AD patients.
• Understanding treatment effectiveness and safety in clinical practice is crucial.

Purpose of the Study:

• To analyze the BIOBADATOP registry for patient characteristics, diagnoses, and treatments.
• To describe adverse events (AEs) associated with systemic therapies for AD.
• To provide initial insights into the safety profile of conventional and novel AD treatments.

Main Methods:

• Prospective, multicenter data collection from the BIOBADATOP registry.
• Analysis of 258 patients and 347 systemic treatments for atopic dermatitis.
• Descriptive statistics of patient demographics, treatments, and reported adverse events.

Main Results:

• Treatment discontinuation occurred in 29.4% of cases, primarily due to lack of effectiveness (10.7%).
• 132 adverse events (AEs) were reported, with 86 linked to systemic treatments like dupilumab and cyclosporine.
• Common AEs included conjunctivitis, headache, hypertrichosis, and nausea; one severe AE (acute mastoiditis) was linked to cyclosporine.

Conclusions:

• Initial findings from BIOBADATOP on AEs are limited by short follow-up.
• No severe AEs were reported for novel systemic therapies at the time of analysis.
• The BIOBADATOP registry is valuable for assessing the real-world effectiveness and safety of AD treatments.