Related Experiment Video
Updated: Jan 9, 2026
Resolving Water, Proteins, and Lipids from In Vivo Confocal Raman Spectra of Stratum Corneum through a Chemometric Approach
Published on: September 26, 2019
Characteristics, Treatment, and Safety Profile of Patients With Atopic Dermatitis According to Eligibility for
M Munera-Campos1, A González Quesada2, M Espasandín Arias3
1Departmentd of Dermatología, Hospital Universitari Germans Trias i Pujol, Departament de Medicina, Universitat Autonoma de Barcelona (UAB), Germans Trias i Pujol Research Institute (IGTP), Badalona, Barcelona, Spain.
Background:
Randomized clinical trials (RCTs) supporting advanced treatments for atopic dermatitis (AD) involve highly selected patients, limiting their generalizability.
Objective:
To determine the proportion of adults on advanced systemic therapy for AD in clinical practice who are underrepresented in RCTs and 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, 1 of 8 common exclusion factors: age≥65 years; pregnancy desire pregnancy or lactation; uncontrolled hypertension, cardiovascular disease, or diabetes; chronic kidney disease; cancer diagnosis; liver disease; history of tuberculosis, human immunodeficiency virus or hepatitis B or C infection; and active or acute infection.
Results:
Of the 366 adults in BIOBADATOP on advanced systemic therapies for AD, 18.3% would be considered ineligible to participate in RCTs. Ineligible patients were older and had more comorbidities than eligible patients. Inclusion of an EASI score<16 at baseline in the sensitivity analysis increased the proportion of ineligible patients to 37.2%. Janus kinase inhibitors were used less often as a first-line therapy in RCT-ineligible patients. Although serious adverse events were significantly more common in ineligible patients, this difference was lost after adjusting for age, sex, and comorbidities.
Conclusions:
Overall, 18.3% of real-world patients with AD-and 37.2% including 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.
Insights
Many adults with atopic dermatitis (AD) are excluded from clinical trials. Real-world data shows these patients have similar safety outcomes when age and comorbidities are considered.
Area of Science:
- Dermatology
- Clinical Pharmacology
- Real-world Evidence
Background:
- Randomized clinical trials (RCTs) for atopic dermatitis (AD) treatments often use strict eligibility criteria, limiting generalizability to the broader patient population.
- This leads to a potential underrepresentation of certain patient groups in trial findings.
Purpose of the Study:
- To quantify the proportion of adults with AD on advanced systemic therapy who are ineligible for RCTs.
- To compare the safety and drug survival of these therapies between RCT-eligible and RCT-ineligible patients in a real-world setting.
Main Methods:
- Analysis of the Spanish Atopic Dermatitis registry (BIOBADATOP) for adults on advanced systemic therapy.
- Patients were classified as RCT-ineligible based on common exclusion criteria (e.g., age, comorbidities, specific health conditions).
- Safety and drug survival were compared between eligible and ineligible groups.
Main Results:
- 18.3% of patients in clinical practice were ineligible for RCTs, a figure rising to 37.2% when considering a lower EASI score threshold.
- Ineligible patients were older and had more comorbidities.
- While serious adverse events were initially higher in ineligible patients, this difference diminished after adjusting for demographic and clinical factors.
Conclusions:
- A significant proportion of real-world atopic dermatitis patients are underrepresented in clinical trials.
- Patient age and comorbidities are crucial factors influencing treatment safety and should guide clinical decisions and future trial design.
Related Concept Videos
01:16Clinical Trials
There are four phases in a clinical trial. A phase one...
01:15Bioavailability Study Design: Healthy Subjects Versus Patients
01:11Clinical Trials: Overview
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
01:28Drug Products: Biologics, Biosimilars and Interchangeables
01:01Dosage Regimens: Partial Pharmacokinetic Parameters