Characteristics, treatment, and safety profile in patients with atopic dermatitis based on eligibility for randomized clinical trials: An analysis of the Spanish Atopic Dermatitis Registry (BIOBADATOP)
Background: Advanced systemic treatments for moderate to severe atopic dermatitis (AD) have appeared in recent years. The efficacy and safety of these treatments, however, is supported by data from randomized clinical trials (RCTs) involving a highly selected group of patients. This limits the gener...
| Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | article |
| Publication Date: | 2026 |
| Country: | España |
| Institution: | Universitat Autònoma de Barcelona |
| Repository: | Dipòsit Digital de Documents de la UAB |
| Language: | English |
| OAI Identifier: | oai:ddd.uab.cat:317820 |
| Online Access: | https://ddd.uab.cat/record/317820 https://dx.doi.org/urn:doi:10.1016/j.ad.2025.104489 |
| Access Level: | Open access |
| Keyword: | Atopic dermatitis JAK inhibitors Biologics Prospective cohort Inclusion criteria Clinical trials Safety Survival analysis Competing risks |
| Summary: | Background: Advanced systemic treatments for moderate to severe atopic dermatitis (AD) have appeared in recent years. The efficacy and safety of these treatments, however, is supported by data from randomized clinical trials (RCTs) involving a highly selected group of patients. This limits the generalizability of trial findings to the broader population of AD patients. Objective: To determine the proportion of patients receiving advanced systemic treatments for AD in routine clinical practice who are underrepresented in RCTs and to compare the safety and drug survival of these treatments between RCT-eligible and RCT-ineligible patients. Material and methods: Descriptive and comparative analysis of data from the Spanish atopic dermatitis registry BIOBADATOP. Patients were deemed RCT-ineligible if they met at least one of eight common exclusion factors: age ≥65 years; pregnancy desire, pregnancy, or lactation; uncontrolled hypertension, cardiovascular disease, or diabetes; chronic renal disease; current or past cancer diagnosis; liver disease; history of tuberculosis, human immunodeficiency virus or hepatitis B or C infection; and active or acute infection, including superinfection of AD lesions. Results: Of the 366 patients in BIOBADATOP on advanced systemic treatments for AD in March 2024, 18.3% would not be eligible to participate in an RCT. Ineligible patients were older and had more comorbidities than eligible patients. Inclusion of an Eczema Area and Severity Index (EASI) score <16 in the sensitivity analysis increased the proportion of ineligible patients to 22.1%. Janus kinase inhibitors were used less often as a first treatment in RCT-ineligible patients. Serious adverse events were significantly more common in ineligible patients, but this difference was lost after adjusting for age, sex, and comorbidities. Conclusions: Overall, 18.3% of real-world patients with AD-and 22.1% of those with EASI <16-are underrepresented in RCTs. Age and comorbidities influence safety outcomes and should be considered when taking treatment decisions and designing RCTs. |
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