A Real-world Study of Deucravacitinib in the Treatment of Moderate to Severe Plaque Psoriasis With Eczematous Features
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Deucravacitinib 6mg po qd.
- Who it may be relevant to
- Registry conditions: Psoriasis, Eczema, JAK Inhibitor. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Observational Study Evaluating the Efficacy and Safety of Deucravacitinib in the Treatment of Moderate to Severe Plaque Psoriasis Patients With Eczematous Features in a Real-world Research
Overview
Emerging evidence indicates that psoriasis and eczema can coexist in the same patient, with reported co-prevalence rates ranging from 0.17% to 20%, suggesting that these conditions may represent a disease spectrum-referred to as Psoriasis Eczema (PsEma). Moreover, paradoxical eczema has been observed in approximately 1% to 12.1% of psoriasis patients undergoing biologic therapy, with up to 61% of affected individuals discontinuing treatment due to eczematous flares. These findings underscore an urgent need for therapeutic agents that are efficacious for PsEma. Tyrosine kinase 2 (TYK2), a member of the Janus kinase (JAK) family, is known to mediate critical signaling pathways involved in psoriasis pathogenesis, including those of type I interferons, interleukin (IL)-12, and IL-23. Additionally, TYK2 forms heterodimers with other JAK family members-such as JAK1 or JAK2-to transduce signals from cytokines like IL-13 and IL-22, which are centrally implicated in the pathophysiology of eczema. Based on this molecular profile, we hypothesize that TYK2 inhibition may not only avoid inducing eczematous reactions in psoriasis patients but may also alleviate eczematous inflammation by interfering with JAK1(JAK2)/TYK2-mediated IL-13 and IL-22 signaling. Deucravacitinib, a selective allosteric TYK2 inhibitor, has shown promising results in our clinical practice, demonstrating improvements in both psoriatic and eczematous manifestations among patients with PsEma. This study aims to prospectively evaluate the efficacy and safety of deucravacitinib in PsEma patients over a 16-week treatment period. In parallel, transcriptomic profiling of peripheral blood and lesional skin will be performed to elucidate the immunological landscape and molecular signatures underlying PsEma, thereby contributing valuable clinical and mechanistic insights into its diagnosis and management.
Detailed description
Eczema-like psoriasis, also referred to as psoriasis-eczema overlap, is a distinct clinical and immunopathological entity that presents with features of both chronic plaque psoriasis and atopic dermatitis (AD). It is increasingly recognized in dermatological practice but remains under-characterized in the literature. Clinically, patients may exhibit erythematous, scaly plaques typical of psoriasis, alongside intense pruritus, oozing, and lichenification more typical of eczematous dermatitis. Histologically, such lesions often display psoriasiform epidermal hyperplasia with superimposed spongiosis, eosinophilic infiltration, and crusting-hallmarks of an eczematous response.
Interventions
- Drug Deucravacitinib 6mg po qd
oral administration
Primary outcome measures
- Percentage of patients with PASI75 [Time frame: From enrollment to the end of treatment at 24 weeks]
- Change from baseline in PASI [Time frame: From enrollment to the end of treatment at 24 weeks]
- Proportion of patients with s-PGA 0 or 1 [Time frame: From enrollment to the end of treatment at 24 weeks]
Secondary outcome measures (3)
- Proportion of patients with IGA 0 or 1 [Time frame: From enrollment to the end of treatment at 24 weeks]
- change of BSA in eczema from baseline [Time frame: From enrollment to the end of treatment at 24 weeks]
- Changes from baseline in WI-NRS [Time frame: From enrollment to the end of treatment at 24 weeks]
Eligibility criteria
Inclusion criteria
1.patients who present typical psoriasis and typical eczema; 2.patients present untypical psoriasis lesions, biopsy result reveals both psoriasis and eczema features; 3.BSA≥3 and IGA≥3.
Exclusion Criteria:① Local use of therapeutic drugs (such as glucocorticoids, calcineurin inhibitors, etc.) within 2 weeks Vitamin D derivatives, retinoid drugs); Received biological treatment within 4 weeks or 4 half lives Agents or their immunosuppressive/immunomodulatory agents (such as cyclosporine, methotrexate, JAK inhibitors);
- Suffering from active autoimmune diseases; Active tuberculosis infection; Hepatitis B surface antigen positive; Uncontrolled systemic diseases such as heart failure, cerebrovascular disease, and liver and kidney dysfunction;
- Known or suspected history of immunosuppression, or although the infection has disappeared, it has been assessed by the researcher as possible Frequent publication of authors;
- History of malignant tumors in the past, or current occurrence of any malignant tumors (excluding basal tumors cured for ≥ 1 year) Cell carcinoma, local squamous cell carcinoma of the skin, or cervical cancer in situ;
- Pregnant or lactating women, or those with pregnancy plans during the trial period.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Shanghai general hospital, Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT06999941 · 20240924103453152