This was a retrospective observational study that relied on data extracted from patient chart review at the participating sites. At least 12 months of patient data was verified, comprising at least 6 months (pre-period) and 6 months (post-period) after secukinumab initiation (index date). All data extracted from patient charts was entered into an electronic case report form (eCRF), specifically designed to capture all variables needed for the study data analysis.
Study Type
OBSERVATIONAL
Enrollment
232
Novartis
São Paulo, Brazil
Proportion of Patients With Disease-related Clinical Manifestations During 6 Months Before and 6 Months After Secukinumab Initiation
Time frame: Up to 1 year
Proportion of Patients With Disease-related Clinical Manifestations During 6 Months Before Secukinumab Introduction Who Experienced Reduced or Eliminated Manifestations During 6 Months of Secukinumab Treatment
Time frame: Up to 1 year
Proportion of Patients With Disease-related Clinical Manifestations During 6 Months Before Secukinumab Introduction Who Experienced Increased Clinical Manifestations During 6 Months of Secukinumab Treatment
Time frame: Up to 1 year
Proportion of Patients With Disease-related Clinical Manifestations at the Time of Secukinumab Introduction Who Experienced Reduced or Eliminated Manifestations During 6 Months of Secukinumab Treatment
Time frame: Up to 6 months
Proportion of Patients With Disease-related Clinical Manifestations at the Time of Secukinumab Introduction Who Experienced Increased Manifestations During 6 Months of Secukinumab Treatment
Time frame: Up to 6 months
Age
Time frame: Baseline
Gender
Time frame: Baseline
Ethnicity
Time frame: Baseline
Time Since First PsA Symptoms
Time frame: Baseline
Time Since First PsO Symptoms
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Time frame: Baseline
Proportion of Patients With Disease-related Clinical Manifestations at Diagnosis
Time frame: Baseline
Proportion of Patients per Screening Tool Used for PsA and PsO Diagnosis
PsA and PsO screening tools included Psoriasis Area and Severity Index (PASI), Body Surface Area (BSA), Dermatology Life Quality Index (DLQI), Disease activity in PsA (DAPSA), and Health Assessment Questionnaire Disability Index (HAQ-DI).
Time frame: Up to 1 year
Psoriasis Area and Severity Index (PASI)
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease).
Time frame: Up to 1 year
Body Surface Area (BSA)
Time frame: Up to 1 year
Dermatology Life Quality Index (DLQI)
The DLQI is a validated, 10-question, self-reported questionnaire to evaluate the patient's perception of the impact of skin disease on quality of life. The DLQI is rated on a 4-point scale (0 = not at all to 3 = very much). The highest possible total score for the DLQI is 30, and higher scores indicate more severe impact on quality of life.
Time frame: Up to 1 year
Disease activity in PsA (DAPSA)
The Disease Activity Index for Psoriatic Arthritis (DAPSA) is a tool used to measure PsA activity: remission (0-4); low disease activity (5-14); moderate disease activity (15-28); high disease activity (\>28).
Time frame: Up to 1 year
Health Assessment Questionnaire Disability Index (HAQ-DI)
The HAQ-DI is a 20-question scale assessing functional ability. The final HAQ-DI score ranges from 0 (no problems functioning) to 3 (not able to function).
Time frame: Up to 1 year
Proportion of Patients per Treatment History Prior to Secukinumab Initiation
Time frame: Up to 6 months
Proportion of Patients per Line of treatment (LOT) of PsA/PsO-target Treatment Before Secukinumab Initiation
Time frame: Up to 6 months
Proportion of Patients With Disease-related Clinical Manifestations per Biologic Naïve and Non-biologic Naïve Patients, Categorized by Disease Severity
Time frame: Up to 6 months
Proportion of Patients With Concomitant Medications, per Category
Time frame: Up to 1 year