Real World Study on the Efficacy and Safety of Apremilast in Chinese Patients With Moderate to Severe Plaque Psoriasis, a Multi Center, Prospective, Observational Trial（REACT）

Study Overview
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Brief Summary
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This is a multicenter, one-arm, prospective, observational study，intended to assess evaluation of efficacy and safety of Apremilast in Chinese patients with moderate-to-severe plaque psoriasis。During this study, it is expected to collect data at at baseline and weeks 2, 6, 10, 16, and 20 after treatment。

Official Title
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Real World Study on the Efficacy and Safety of Apremilast in Chinese Patients With Moderate to Severe Plaque Psoriasis, a Multi Center, Prospective, Observational Trial（REACT）

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Apremilast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females, ≥ 18 years of age at the time of signing the informed consent document； Patients with moderate-to-severe plaque psoriasis：Simultaneously meet (1)and (2): (1)PASI≥ 3；(2) DLQI ≥ 6； Subject is a candidate for phototherapy and/or systemic therapy Patients who wish to be treated with Apremilast and sign the informed consent Exclusion Criteria: Allergy to Apremilast or any component of the study drug； Use of phototherapy within 4 weeks prior to randomization；Use of systemic drugs or biologic agents within 4 half-life periods prior to randomization；Patients with inadequate response or intolerance to previous systemic therapy do not need to consider drug washout； Currently using potent cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin, etc.)； History of substance abuse, suicide attempts, or mental illness； Patients who are currently pregnant, breastfeeding, or planning a pregnancy during the study observation period； Pustular type, erythroderma type and other psoriasis patients； Other circumstances that investigators don't consider appropriate to include.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Apremilast<br>Dosage of Apremilast（Otezla®） from 10mg qd, titrate to recommended dosage of 30 mg BID，recommended by specification. | Drug: Apremilast<br>* Dosage of Apremilast（Otezla®） from 10mg qd, titrate to recommended dosage of 30 mg BID，recommended by specification.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DLQI or PASI improvement | At week 16，Proportion of patients with DLQI improvement (DLQI ≤5 or DLQI improvement by ≥4 points from baseline) or PASI improvement (PASI <3) | 16 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASI, PGA, BSA, DLQI, pruritus VAS and pain VAS | Absolute values of change from baseline in PASI, PGA, BSA, DLQI, pruritus VAS and pain VAS in subjects at week 16 of treatment | 16 week | 
| DLQI improvement | Proportion of patients with DLQI score ≤5 or improvement ≥4 points from baseline at each visits | 2 week | 
| DLQI improvement | Proportion of patients with DLQI score ≤5 or improvement ≥4 points from baseline at each visits | 6 week | 
| DLQI improvement | Proportion of patients with DLQI score ≤5 or improvement ≥4 points from baseline at each visits | 10 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Apremilast, Otazla, Real World Study