A Prospective Multicenter Study for the Assessment of Treatment Patterns, Effectiveness and Safety of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis in a Real-world Setting in China (UNMASK2)

This non-interventional, prospective, multi-center study aims to provide short- and long- term treatment patterns, effectiveness, and safety of secukinumab in Chinese patients with moderate to severe plaque psoriasis (with and without PsA) initiating treatment of secukinumab.

Study Overview

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

Detailed Description

All patients will be followed up for 52 weeks no matter they adhere to secukinumab or they have shifted to other treatment plans. Data will be collected in conjunction with routine care visits, most likely happen at week 0, 4, 12, 16, 24, 36, 52. No extra study visits, examinations, laboratory tests or procedures will be mandated. If visits happen at other time points (not within the window period), then they will be counted as unscheduled visits.

• Study Type: Observational
• Enrollment (Actual): 1002

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100034
    • Novartis Investigative Site
  • Beijing, China, 100191
    • Novartis Investigative Site
  • Chongqing, China, 400011
    • Novartis Investigative Site
  • Jinan, China, 250012
    • Novartis Investigative Site
  • Nanjing, China, 210042
    • Novartis Investigative Site
  • Shanghai, China, 200025
    • Novartis Investigative Site
  • Shanyang, China, 110005
    • Novartis Investigative Site
  • Tianjin, China, 300052
    • Novartis Investigative Site
  • Wuhan, China, 430022
    • Novartis Investigative Site
  • Zhejiang, China, 315016
    • Novartis Investigative Site
  • Beijing
    • Xicheng Direct, Beijing, China, 100044
      • Novartis Investigative Site
  • Chongqing
    • Chongqing, Chongqing, China, 400010
      • Novartis Investigative Site
  • Gansu
    • Lanzhou, Gansu, China, 730030
      • Novartis Investigative Site
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Novartis Investigative Site
    • Shen Zhen, Guangdong, China, 518116
      • Novartis Investigative Site
    • Shenzhen, Guangdong, China, 518020
      • Novartis Investigative Site
  • Guangzhou
    • Guangdong, Guangzhou, China, 510091
      • Novartis Investigative Site
  • Hainan
    • Haikou, Hainan, China, 571127
      • Novartis Investigative Site
  • Hebei
    • Handan, Hebei, China, 056002
      • Novartis Investigative Site
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Novartis Investigative Site
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Novartis Investigative Site
  • Hunan
    • Changsha, Hunan, China, 410003
      • Novartis Investigative Site
    • Changsha City, Hunan, China, 410011
      • Novartis Investigative Site
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • Novartis Investigative Site
    • Xuzhou, Jiangsu, China, 221003
      • Novartis Investigative Site
  • Jilin
    • Changchun, Jilin, China, 130041
      • Novartis Investigative Site
  • Ningxia
    • Yinchuan, Ningxia, China, 100039
      • Novartis Investigative Site
  • Shandong
    • Jinan, Shandong, China, 250021
      • Novartis Investigative Site
    • Jinan, Shandong, China, 250022
      • Novartis Investigative Site
    • Qingdo, Shandong, China, 266033
      • Novartis Investigative Site
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • Novartis Investigative Site
    • Shanghai, Shanghai, China, 200437
      • Novartis Investigative Site
    • Shanghai, Shanghai, China, 200071
      • Novartis Investigative Site
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • Novartis Investigative Site
    • XI An, Shanxi, China, 710061
      • Novartis Investigative Site
    • Xian, Shanxi, China, 710004
      • Novartis Investigative Site
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Novartis Investigative Site
    • Chengdu, Sichuan, China, 610017
      • Novartis Investigative Site
  • Tianjin
    • Tianjin, Tianjin, China, 300192
      • Novartis Investigative Site
  • Xinjiang
    • Urumqi, Xinjiang, China, 830001
      • Novartis Investigative Site
    • Urumqi, Xinjiang, China, 830000
      • Novartis Investigative Site
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with confirmed diagnosis of moderate to severe plaque psoriasis initiating secukinumab will be eligible for this study.

Description

Inclusion Criteria:

• Aged ≥ 18 years;
• Diagnosis of clinically moderate to severe plaque-psoriasis;
• Initiating treatment with secukinumab during the identification period or within 30 days prior to the index date;
• Patient agrees to sign the informed consent

Exclusion Criteria:

- Participation in any dermatology or rheumatology clinical trial, concurrent or within the last 30 days of the secukinumab initiating date

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
secukinumab; Patients administered secukinumab by prescription	Drug: secukinumab; There is no treatment allocation. Patients administered secukinumab by prescription that have started before inclusion of the patient into the study will be enrolled.; Other Names: Cosentyx

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients achieving a 90% reduction in the Psoriasis Area and Severity Index (PASI) score	The PASI is used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0.	week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients experiencing a 75% reduction of PASI (PASI75)	The PASI is used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0.	week 4, week12, week 16, week 24, week 36, week 52
Percentage of patients experiencing a 90% reduction of PASI (PASI90)	The PASI is used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0.	week 4, week12, week 16, week 36, week 52
Percentage of patients experiencing a 100% reduction of PASI (PASI100)	The PASI is used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0.	week 4, week12, week 16, week 24, week 36, week 52
Percentage of patients with absolute PASI change ≤1, ≤2, ≤3,and ≤5	The PASI is used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0	week 4, week12, week 16, week 24, week 36, week 52
Percentage of patients with Investigator Global Assessment Mod 2011 (IGA mod 2011) 0 or 1	The IGA mod 2011 rating scale for overall psoriatic disease can range from 0 to 4 (0: Clear, 1: almost clear, 2: mild, 3: moderate, 4: severe)	week 4, week12, week 16, week 24, week 36, week 52
Mean change of Investigator Global Assessment Mod 2011(IGA mod 2011)	The IGA mod 2011 rating scale for overall psoriatic disease can range from 0 to 4 (0: Clear, 1: almost clear, 2: mild, 3: moderate, 4: severe)	week 4, week12, week 16, week 24, week 36, week 52
Percentage of patients achieved (Body Surface Area) BSA≤1%	The total BSA affected by plaque-type psoriasis will be estimated from the percentages of areas affected, including head, trunk, upper limbs and lower limbs. The following calculations will be done: each reported percentage will be multiplied by its respective body region corresponding factor (head = 0.1, trunk = 0.3, upper limbs = 0.2, lower limbs = 0.4). The resulting four percentages will be added up to estimate the total BSA affected by psoriasis.	week 4, week12, week 16, week 24, week 36, week 52
Mean change in Dermatology life quality index (DLQI)	DLQI is a 10-item general dermatology disability index designed to assess HRQoL in adult patients with skin diseases such as eczema, psoriasis, acne and viral warts. The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment and work/school. Each item has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30 and higher scores indicate greater HRQoL impairment. Additionally, each subscale of the DLQI may be analyzed separately.	Baseline,week 4, week12, week 16, week 24, week 36, week 52
Percentage of patients achieving DLQI 0 or 1 response	DLQI is a 10-item general dermatology disability index designed to assess HRQoL in adult patients with skin diseases such as eczema, psoriasis, acne and viral warts. The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment and work/school. Each item has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30 and higher scores indicate greater HRQoL impairment. Additionally, each subscale of the DLQI may be analyzed separately.	week 4, week12, week 16, week 24, week 36, week 52
Incidence of AEs/SAEs	An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Serious adverse event (SAE) is defined as an AE which results in death or is life-threatening, persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant	52 weeks
Incidence of treatment-related AEs on-treatment and post-discontinuation follow up	An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	52 weeks
Incidence of unexpected treatment related AEs/SAEs on-treatment and post-discontinuation follow up	An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Serious adverse event (SAE) is defined as an AE which results in death or is life-threatening, persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant	52 weeks
Incidence of treatment-related SAEs on-treatment and post-discontinuation follow up	Serious adverse event (SAE) is defined as an AE which results in death or is life-threatening, persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant	52 weeks
Incidence of AEs of special interest on-treatment and post discontinuation follow up	An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	52 weeks
Proportion of patients experiencing at least one AE	An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	52 weeks
Average number of AEs per patient	An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	52 weeks
Percentage of secukinumab discontinuation caused by AE	An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	52 weeks
Frequency distribution of patients by dosing pattern	Frequency distribution of patients by dosing pattern will be collected	52 weeks
Frequency distribution of patients by secukinumab retention	Percentage of patients who are persistent secukinumab users or who discontinue secukinumab	Week 4, week 12, week 16, week 24, week 36 and week 52
Mean (SD) time to secukinumab discontinuation	Mean (SD) time to secukinumab discontinuation will be collected	Up to 52 weeks
Median (interquartile range) time to secukinumab discontinuation	Median (IQR) time to secukinumab discontinuation will be collected	52 weeks

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2021
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: China; psoriasis; secukinumab; real world study
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: CAIN457ACN06

Plan for Individual participant data (IPD)

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