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

Recruiting

• 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: 2021-11-19
• Study First Submitted: 2023-07-25
• Study First Submitted QC: 2023-08-04
• Study First Posted: 2023-08-14
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-07
• Primary Completion: 2023-12-31
• Study Completion: 2031-11-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

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
Patient-oriented eczema measure (POEM)	every 12 weeks	Monitoring atopic eczema severity
Dermatology life quality index (DLQI)	every 12 weeks	Assessment of the patient's quality of life

Trial Locations

Locations (1)

Irccs Fondazione Policlinico Gemelli; 🇮🇹 Roma, Italy