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This study was a retrospective non-interventional cohort study with secondary use of data from the Medical Data Vision (MDV) hospital-based database. The study setting was defined as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secukinumab | Patients had received secukinumab treatment. |
| |
| Adalimumab | Patients had received adalimumab treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab | Drug | Patients had received secukinumab per their dosing regimens prior to this observational study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients with Persistence of Secukinumab Treatment at One Year | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Sex | Baseline | |
| Age | Baseline | |
| Number of Patients, Categorized by Medical Facility Department |
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Inclusion criteria:
Bio-naive subgroup:
• Patients were considered as bio-naive if no record of any biologic agent prescriptions indicated for psoriasis or PsA (infliximab, adalimumab, certolizumab pegol, ustekinumab, risankizumab, guselkumab, secukinumab, ixekizumab, brodalumab - princeps or biosimilars) were retrieved during the pre-index period.
Exclusion Criteria:
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This was a retrospective, noninterventional cohort study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Pharma K.K. | Tokyo | 105-6333 | Japan |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Adalimumab | Drug | Patients had received adalimumab per their dosing regimens prior to this observational study. |
|
| Baseline |
| Height | Baseline |
| Weight | Baseline |
| Body Mass Index (BMI) | Baseline |
| Time from PsA Diagnosis to Index Date, Categorized by Medical Facility Department | Up approximately 6 months |
| Number of Patients with Comorbidities, by Category | Baseline |
| Number of Patients on Concomitant Treatments | Baseline |
| C-reactive Protein (CRP) | Baseline |
| Change in C-reactive Protein (CRP) Since Administration of Secukinumab or Adalimumab in Patients Still Treated with the Drug at the End of Follow-up | Up to approximately 5 years |
| Change in C-reactive Protein (CRP) Since Administration of Secukinumab or Adalimumab in Patients Who Discontinued the Drug | Up to approximately 5 years |
| Time from Index Date to the Start of Methotrexate Add-on | Up to approximately 5 years |
| Time from Index Date to Methotrexate Discontinuation in Methotrexate Naive Patients at Index Date | Up to approximately 5 years |
| Time from Index Date to Methotrexate Discontinuation in Methotrexate Experienced Patients at Index Date | Up to approximately 5 years |
| Secukinumab/adalimumab Dose at the Start of Methotrexate Add-on | Up to approximately 5 years |
| Secukinumab/adalimumab Dose at Methotrexate Discontinuation | Up to approximately 5 years |
| Number of Patients with Methotrexate Add-on During Follow-up | Up to approximately 5 years |
| Average Secukinumab/adalimumab Dose at Index Date | Baseline |
| Number of Patients with Persistence of Secukinumab or Adalimumab Treatment | 24 weeks, 1 year, 1.5 years, 2 years, 2.5 years, and 3 years |
| Time from PsA Diagnosis to Index Date for Adalimumab Patients | Up approximately 6 months |
| Number of Adalimumab Patients, Categorized by Medical Facility | Baseline |
| Number of Patients with Presence or Absence of Methotrexate | Baseline |
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |