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.
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
1,002
There is no treatment allocation. Patients administered secukinumab by prescription that have started before inclusion of the patient into the study will be enrolled.
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.
Time frame: week 24
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novartis Investigative Site
Xicheng Direct, Beijing Municipality, China
Novartis Investigative Site
Chongqing, Chongqing Municipality, China
Novartis Investigative Site
Lanzhou, Gansu, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Shenzhen, Guangdong, China
Novartis Investigative Site
Shenzhen, Guangdong, China
Novartis Investigative Site
Guangdong, Guangzhou, China
Novartis Investigative Site
Haikou, Hainan, China
Novartis Investigative Site
Handan, Hebei, China
Novartis Investigative Site
Zhengzhou, Henan, China
...and 32 more locations
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 52 weeks
Frequency distribution of patients by dosing pattern
Frequency distribution of patients by dosing pattern will be collected
Time frame: 52 weeks
Frequency distribution of patients by secukinumab retention
Percentage of patients who are persistent secukinumab users or who discontinue secukinumab
Time frame: 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
Time frame: Up to 52 weeks
Median (interquartile range) time to secukinumab discontinuation
Median (IQR) time to secukinumab discontinuation will be collected
Time frame: 52 weeks