A Real-world Study of Tuberculosis Incidence in AS, PsA, or PsO Patients Treated With Secukinumab in Brazil
- Conditions
- Tuberculosis
- Registration Number
- NCT06715254
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This was a retrospective observational study that relied on data extracted from patient's chart review at the participating centers. Data was entered into an electronic Case Report Form (eCRF) designed to capture all relevant information to achieve the study objectives.
After the ethical approval for each participating site, the respective Investigator and/or designated qualified study staff were responsible for including all eligible patients in a consecutive manner and entering their information into the eCRF. Patients were primarily identified with ankylosing spondylitis (AS), psoriatic arthritis (PsA), and psoriasis (PsO) diagnosis according to the International Classification of Diseases (ICD)-10 code (M45, M07, and L40, respectively). Alternatively, the written diagnosis from applicable departments, such as payment, computing, or data office were also used for patient screening. Potentially eligible patients had their charts reviewed for all selection criteria. Inclusion was performed up to the number of patients determined for each site prior to study initiation or up to completion of sample size. Patient's identification (name, address, and other identifiable data) was not collected and remained confidential.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 152
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Active Tuberculosis Cases per 1000 Patient-years in Biologic Naive Patients Treated With Secukinumab Up to approximately 84 months Biologic naive patients were defined as patients with no previous therapeutic exposure to biologic drugs. Biologic drugs considered were abatacept, adalimumab, certolizumab, etanercept, golimumab, guselkumab, infliximab, ixequizumab, tofacitinibe, and ustekinumab.
- Secondary Outcome Measures
Name Time Method Number of Concomitant Medications Patients Received Before Secukinumab Initiation Baseline Number of Concomitant Medications Patients Received After Secukinumab Initiation Up to approximately 84 months Mean Number of Medications per Patient Before Secukinumab Initiation Baseline Mean Number of Medications per Patient After Secukinumab Initiation Up to approximately 84 months Number of Concomitant Medications Prescribed Before Secukinumab Initiation Categorized by Reason for Medication Prescription Baseline Number of Patients With Comorbidities up to Secukinumab Initiation Baseline Number of Patients per Comorbidity Baseline Number of Active Tuberculosis Cases per 1000 Patient-years in all Patients Treated With Secukinumab Up to approximately 84 months Number of Active Tuberculosis Cases per 1000 Patient-years in Secondary Naive Patients Treated With Secukinumab Up to approximately 84 months Secondary-naïve patients were defined as patients with previous exposure to a biologic drug but with a wash-out period of at least 3 months prior to the index date. The index date was defined as the date when secukinumab was introduced. Biologic drugs considered were abatacept, adalimumab, certolizumab, etanercept, golimumab, guselkumab, infliximab, ixequizumab, tofacitinibe, and ustekinumab.
Number of Patients per Demographic Category Baseline Demographic categories included gender and ethnicity.
Demographic: Age Baseline Demographic: Time to Follow-up From Secukinumab Initiation Up to approximately 84 months Number of Concomitant Medications Prescribed After Secukinumab Initiation Categorized by Reason for Medication Prescription Up to approximately 84 months Number of Most Frequent Medications Used for Comorbidities Before Secukinumab Initiation Categorized by Type of Medication Baseline Number of Most Frequent Medications Used for Comorbidities After Secukinumab Initiation Categorized by Type of Medication Up to approximately 84 months Number of Medications Prescribed for AS, PsA, or PSO Before Secukinumab Initiation Categorized by Type of Medication Baseline Number of Medications Prescribed for AS, PsA, or PSO After Secukinumab Initiation Categorized by Type of Medication Up to approximately 84 months Duration of Primary Diagnosis Baseline Duration of Secukinumab Treatment Up to approximately 84 months Number of Patients per Secukinumab Use Category Up to approximately 84 months Secukinumab use categories included:
* Loading dose prescribed (yes/no)
* Loading dose (150 milligrams \[mg\] or 300 mg)
* Loading dose frequency (once a day, twice a day, every 1, 2, 3, 4 weeks)
* Period of loading dosage (1, 2, 3 weeks, 1, 2 months, other)
* Maintenance dose (150 mg or 300 mg)
* Maintenance dose frequency (once a day, twice a day, every 1, 2, 3, 4 weeks)
* Switch in dose
* Switch dose (150 mg or 300 mg)
* Frequency of switch dose (once a day, twice a day, every 1, 2, 3, 4 weeks)
* Interruption of secukinumab treatmentDuration of Interruption of Secukinumab Treatment Up to approximately 84 months Interruption duration: interruption date of secukinumab minus restart date of secukinumab.
Number of Patients who Used an Immunobiologic Before Secukinumab Baseline Number of Patients who Tested Positive or Negative for Latent Tuberculosis Before Secukinumab Initiation Approximately 6 months Number of Patients who Received Prophylactic Antibiotic Therapy Among Those who Tested Positive for Latent Tuberculosis Before Secukinumab Initiation Approximately 6 months Number of Patients who Tested Positive or Negative for Latent Tuberculosis After Secukinumab Initiation Up to approximately 84 months Number of Patients who Received Prophylactic Antibiotic Therapy Among Those who Tested Positive for Latent Tuberculosis After Secukinumab Initiation Up to approximately 84 months Number of Patients not Tested for Tuberculosis Before Secukinumab Initiation With Prophylactic Antibiotic Use Approximately 6 months Number of Patients Without a Tuberculosis Test Before Secukinumab Initiation Approximately 6 months
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Trial Locations
- Locations (1)
Novartis
🇺🇸East Hanover, New Jersey, United States