Clinical trial NCT05989932: Real-world Experience on the Use of Upadacitinib in the Treatment of Moderate-severe Adult Atopic Dermatitis (ERUDA)
Official title: Esperienza Real-world Sull'Uso di Upadacitinib Nel Trattamento Della Dermatite Atopica Moderata-severa Dell'Adulto
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Dermatitis
Lead sponsor: Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The nature of the study is descriptive. Each center is committed to enlist consecutively all adult patients diagnosed with moderate-severe atopic dermatitis treated with upadacitinib

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

Eligibility criteria: 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

Primary outcomes:
measure: Dermatology life quality index (DLQI)
timeFrame: every 12 weeks
measure: Patient-oriented eczema measure (POEM)
timeFrame: every 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Irccs Fondazione Policlinico Gemelli
Study officials:
References: