Psoriatic Disease and Related Manifestations; Real World Evidence in Brazilian Secukinumab Environment
- Conditions
- Psoriasis (PsO)Psoriatic Arthritis (PsA)
- Registration Number
- NCT06666114
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 232
- Adult patients aged ≥18 years at index date.
- Patients with PsO diagnosed with PsA (concomitant or sequentially), either by a rheumatologist or dermatologist, at least 6 months prior to initiation of secukinumab treatment.
- Continuously treated with secukinumab for at least 24 weeks (6 months) after index date.
- Medical history available from at least the one-year study period (at least 6 months previous to the start of secukinumab treatment and at least 6 months after).
- Patients who interrupted secukinumab treatment for 3 or more months during the 6-month period (post-period) for any cause.
- Patients known to be participating in an interventional study at any point of the one-year study period.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of Patients With Disease-related Clinical Manifestations During 6 Months Before and 6 Months After Secukinumab Initiation 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 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 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 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 Up to 6 months
- Secondary Outcome Measures
Name Time Method Age Baseline Gender Baseline Ethnicity Baseline Time Since First PsA Symptoms Baseline Time Since First PsO Symptoms Baseline Proportion of Patients With Disease-related Clinical Manifestations at Diagnosis Baseline Proportion of Patients per Screening Tool Used for PsA and PsO Diagnosis Up to 1 year 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).
Psoriasis Area and Severity Index (PASI) Up to 1 year PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease).
Body Surface Area (BSA) Up to 1 year Dermatology Life Quality Index (DLQI) Up to 1 year 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.
Disease activity in PsA (DAPSA) Up to 1 year 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).
Health Assessment Questionnaire Disability Index (HAQ-DI) Up to 1 year 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).
Proportion of Patients per Treatment History Prior to Secukinumab Initiation Up to 6 months Proportion of Patients per Line of treatment (LOT) of PsA/PsO-target Treatment Before Secukinumab Initiation Up to 6 months Proportion of Patients With Disease-related Clinical Manifestations per Biologic Naïve and Non-biologic Naïve Patients, Categorized by Disease Severity Up to 6 months Proportion of Patients With Concomitant Medications, per Category Up to 1 year
Trial Locations
- Locations (1)
Novartis
🇧🇷Sao Paulo, Brazil