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）

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。

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Apremilast

• Study Type: Observational
• Enrollment (Actual): 360

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • China-Japan Friendship Hospital
  • Shenyang, China, 110001
    • The First Hospital of China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Chinese patients with moderate to severe plaque psoriasis

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Apremilast; Dosage of Apremilast（Otezla®） from 10mg qd, titrate to recommended dosage of 30 mg BID，recommended by specification.	Drug: Apremilast; Dosage of Apremilast（Otezla®） from 10mg qd, titrate to recommended dosage of 30 mg BID，recommended by specification.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: First Hospital of China Medical University
• Collaborators: China-Japan Friendship Hospital
• Investigators: Study Director: Xinghua Gao, MD, First Hospital of China Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2023
• Primary Completion (Actual): February 10, 2025
• Study Completion (Actual): March 10, 2025

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Apremilast; Real World Study; Otazla
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Phosphodiesterase Inhibitors; Phosphodiesterase 4 Inhibitors; Apremilast
• Other Study ID Numbers: OTL-A-2201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No