AD Treatment Optimization With Ebglyss in Real-World Practice: A Multicenter Study of Patient-Centered Outcomes

Korábbi kezelés

• Prior exposure to Ebglyss; the cohort is limited to participants initiating Ebglyss
• Ongoing use, at enrollment, of another advanced systemic therapy for atopic dermatitis (a short course of an oral corticosteroid, cyclosporine, or an oral JAK inhibitor in progress at enrollment does not exclude a participant if its total duration does not exceed 14 days; phototherapy must be discontinued before the Baseline visit)
• Concurrent enrollment in an interventional clinical trial of an investigational agent for atopic dermatitis
• Inability or unwillingness to provide informed consent or to comply with study requirements
  • Note: No minimum body surface area is required. No protocol-mandated washout is imposed; transitions from prior systemic therapy follow the treating clinician's standard practice. Enrollment of participants with prior biologic or oral JAK inhibitor experience is capped at 30% of the cohort.

Más betegség

• Known serious hypersensitivity to Ebglyss or to any of its excipients
• Known, untreated helminth (parasitic) infection; participants may be reconsidered once the infection has been treated
• Any medical, psychiatric, or social condition that, in the investigator's opinion, would confound interpretation of the data or interfere significantly with completion of study assessments

Egyéb

• Pregnancy or breastfeeding at the time of enrollment (applies at enrollment only; assessed by clinical evaluation and self-report, with no protocol-mandated pregnancy testing)

• Aged 12 years or older and weighing at least 40 kg at the time of consent (the approved Ebglyss population)
• Atopic dermatitis diagnosed per American Academy of Dermatology consensus criteria, and, in the treating clinician's judgment independent of the study, a candidate for advanced systemic therapy per AAD guidelines
• Treating clinician has recommended initiation of Ebglyss, used on-label, as part of routine clinical care, and the participant is appropriate for Ebglyss per the current prescribing information
• Baseline Investigator's Global Assessment (IGA) score of 3 or greater (moderate-to-severe disease)
• Baseline Pruritus Numeric Rating Scale (NRS) score greater than 4
• Willing and able to complete patient-reported outcomes and the monthly remote eSurvey, and to comply with the visit schedule
• Able to provide written informed consent and HIPAA authorization prior to any study-related procedure; for minors, written parental/guardian permission and age-appropriate assent are obtained as required by the reviewing IRB