Psoriasis (PsO), Psoriatic Arthritis (PsA)
Conditions
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Age | 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. |
| Gender | Baseline | — |
| 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 | — |
| 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). |
| 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 | — |
Countries
Brazil
Outcome results
None listed