Real-world Experience on the Use of Upadacitinib in the Treatment of Moderate-severe Adult Atopic Dermatitis (ERUDA)

Completed

• Conditions: Atopic Dermatitis

• Registration Number: NCT05989932
• Lead Sponsor: Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse

Brief Summary

Real-world experience on the use of Upadacitinib in the treatment of Adult moderate-severe atopic dermatitis

Detailed Description

Atopic dermatitis (DA) is a chronic-recurrent inflammatory skin disease with high prevalence in children. Clinical remission is frequently observed during or after childhood although it may persist and/or recur, even after long and transient remission, in adulthood. In addition, in some patients the DA begins in adulthood: in these cases, we speak of DA adult-onset. In addition to the diagnostic framework, it is also important in clinical practice to assess the severity of the disease on which the choice of treatment is based, which will also take into account other factors such as: possible comorbidities, Previously performed therapies and patient needs. For the management of moderate-severe forms of atopic dermatitis topical drugs, phototherapy, traditional immunomodulating drugs and a biological drug are currently available. Compared to other chronic inflammatory skin diseases the therapeutic paraphernalia should be considered limited, with most systemic drugs that have no indication for the treatment of DA (off-label use).

In the pipeline there are numerous drugs that have reached an advanced stage of development. These include upadacitinib, a new-generation oral drug (small molecule) that selectively inhibits the signal mediated by Janus kinases 1 (JAK-1), has recently received approval for treatment of DA by EMA and AIFA to begin compassionate use of patients deemed contraindicated, intolerant, and/or non-responsive to traditional systemic therapies and biological therapy.

* Evaluation of the effectiveness of upadacitinib using the EASI score Secondary objectives

* Evaluation of the safety profile of upadacitinib

* Predictive factors of treatment response

* Assessment of patient quality of life

Study Timeline

• Study Start: 2021-12-15
• Study First Submitted: 2023-07-25
• Study First Submitted QC: 2023-08-04
• Study First Posted: 2023-08-14
• Primary Completion: 2024-04-19
• Study Completion: 2024-04-19
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-16
• Last Update Posted: 2025-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

1. Age 18 years
2. Signature of informed consent
3. Diagnosis of moderate and/or severe DA by a dermatologist specialist
4. Approval of the compassionate use of upadacitinib

Exclusion Criteria

1. Patient unable to give informed consent prior to any collection procedure study data
2. unable to complete the procedures required for the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dermatology life quality index (DLQI)	from enrollment up to 48 weeks	Assessment of the patient's quality of life. There are 10 questions, covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment. Each question refers to the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life) --\> 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect
Patient-oriented eczema measure (POEM)	From enrollment up to 48 weeks	The Patient Oriented Eczema Measure (POEM) is a simple, validated self-report questionnaire used for monitoring atopic eczema severity. It records seven symptoms shown to be important to patients, like itchy, sleep, bleeding ect.. Each of the seven questions carries equal weight and is scored from 0 to 4 as follows: No days = 0; 1-2 days = 1; 3-4 days = 2; 5-6 days = 3; Every day = 4. The meaning is: 0 to 2 = Clear or almost clear; 3 to 7 = Mild eczema; 8 to 16 = Moderate eczema; 17 to 24 = Severe eczema; 25 to 28 = Very severe eczema.

Trial Locations

Locations (1)

Irccs Fondazione Policlinico Gemelli; 🇮🇹 Roma, Italy