Real-world Experience on the Use of Upadacitinib in the Treatment of Moderate-severe Adult Atopic Dermatitis (ERUDA)
Study Details
Study Description
Brief Summary
Real-world experience on the use of Upadacitinib in the treatment of Adult moderate-severe atopic dermatitis
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
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Evaluation of the effectiveness of upadacitinib using the EASI score Secondary objectives
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Evaluation of the safety profile of upadacitinib
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Predictive factors of treatment response
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Assessment of patient quality of life
Study Design
Outcome Measures
Primary Outcome Measures
- DLQI [baseline and every 12 weeks]
- POEM [baseline and every 12 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 years
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Signature of informed consent
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Diagnosis of moderate and/or severe DA by a dermatologist specialist
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Approval of the compassionate use of upadacitinib
Exclusion Criteria:
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Patient unable to give informed consent prior to any collection procedure study data
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unable to complete the procedures required for the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Irccs Fondazione Policlinico Gemelli | Roma | Italy | 00168 |
Sponsors and Collaborators
- Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SID02