Psoriasis
Conditions
Keywords
Apremilast, Otazla, Real World Study
Brief summary
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。
Interventions
DRUGApremilast
Dosage of Apremilast（Otezla®） from 10mg qd, titrate to recommended dosage of 30 mg BID，recommended by specification.
Sponsors
China-Japan Friendship Hospital
First Hospital of China Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DLQI or PASI improvement | 16 week | At week 16，Proportion of patients with DLQI improvement (DLQI ≤5 or DLQI improvement by ≥4 points from baseline) or PASI improvement (PASI \<3) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PASI, PGA, BSA, DLQI, pruritus VAS and pain VAS | 16 week | Absolute values of change from baseline in PASI, PGA, BSA, DLQI, pruritus VAS and pain VAS in subjects at week 16 of treatment |
| DLQI improvement | 2 week | Proportion of patients with DLQI score ≤5 or improvement ≥4 points from baseline at each visits |
Countries
China
Outcome results
None listed