A Real-world Study of Tuberculosis Incidence in AS, PsA, or PsO Patients Treated With Secukinumab in Brazil

Novartis Pharmaceuticals152 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

152

Conditions

Tuberculosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Documented diagnosis with AS, PsA, or PsO, regardless of its severity, by a physician as per patient chart up to secukinumab introduction. 2. Patient treated with secukinumab monotherapy for at least 24 months since 01 January 2016 in Brazil, in accordance with local labelling approval. 3. Biologic-naïve or secondary-naïve patient, who was not using biologic drug for at least 3 months prior to secukinumab introduction. 4. Medical history available from the entire study period i.e., at least 6 months before and 24 months after secukinumab introduction. Exclusion criteria: 1. No access or availability of patient medical chart. 2. Patient who did not use approved dosing regimens for secukinumab therapy, as per local label. 3. Patient with confirmed clinical history of active tuberculosis or mendelian susceptibility to mycobacterium diseases prior to secukinumab use. 4. Patient treated with systemic corticosteroid doses with immunosuppressant features (prednisone dose higher than 10 milligrams \[mg\] or its equivalent) for at least 2 consecutive weeks or other concomitant immunosuppressant drug during the study period.

Outcomes

Primary Outcomes

Number of Active Tuberculosis Cases per 1000 Patient-years in Biologic Naive Patients Treated With Secukinumab

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.

Time frame: Up to approximately 84 months

Secondary Outcomes

Number of Active Tuberculosis Cases per 1000 Patient-years in all Patients Treated With Secukinumab

Time frame: Up to approximately 84 months

Number of Active Tuberculosis Cases per 1000 Patient-years in Secondary Naive Patients Treated With Secukinumab

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.

Time frame: Up to approximately 84 months

Number of Patients per Demographic Category

Demographic categories included gender and ethnicity.

Time frame: Baseline

Demographic: Age

Time frame: Baseline

Demographic: Time to Follow-up From Secukinumab Initiation

Time frame: Up to approximately 84 months

Number of Patients With Comorbidities up to Secukinumab Initiation

Time frame: Baseline

Number of Patients per Comorbidity

Time frame: Baseline

Number of Concomitant Medications Patients Received Before Secukinumab Initiation

Time frame: Baseline

Number of Concomitant Medications Patients Received After Secukinumab Initiation

Time frame: Up to approximately 84 months

Mean Number of Medications per Patient Before Secukinumab Initiation

Time frame: Baseline

Mean Number of Medications per Patient After Secukinumab Initiation

Time frame: Up to approximately 84 months

Number of Concomitant Medications Prescribed Before Secukinumab Initiation Categorized by Reason for Medication Prescription

Time frame: Baseline

Number of Concomitant Medications Prescribed After Secukinumab Initiation Categorized by Reason for Medication Prescription

Time frame: Up to approximately 84 months

Number of Most Frequent Medications Used for Comorbidities Before Secukinumab Initiation Categorized by Type of Medication

Time frame: Baseline

Number of Most Frequent Medications Used for Comorbidities After Secukinumab Initiation Categorized by Type of Medication

Time frame: Up to approximately 84 months

Number of Medications Prescribed for AS, PsA, or PSO Before Secukinumab Initiation Categorized by Type of Medication

Time frame: Baseline

Number of Medications Prescribed for AS, PsA, or PSO After Secukinumab Initiation Categorized by Type of Medication

Time frame: Up to approximately 84 months

Duration of Primary Diagnosis

Time frame: Baseline

Duration of Secukinumab Treatment

Time frame: Up to approximately 84 months

Number of Patients per Secukinumab Use Category

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 treatment

Time frame: Up to approximately 84 months

Duration of Interruption of Secukinumab Treatment

Interruption duration: interruption date of secukinumab minus restart date of secukinumab.

Time frame: Up to approximately 84 months

Number of Patients who Used an Immunobiologic Before Secukinumab

Time frame: Baseline

Number of Patients who Tested Positive or Negative for Latent Tuberculosis Before Secukinumab Initiation

Time frame: Approximately 6 months

Number of Patients who Received Prophylactic Antibiotic Therapy Among Those who Tested Positive for Latent Tuberculosis Before Secukinumab Initiation

Time frame: Approximately 6 months

Number of Patients who Tested Positive or Negative for Latent Tuberculosis After Secukinumab Initiation

Time frame: Up to approximately 84 months

Number of Patients who Received Prophylactic Antibiotic Therapy Among Those who Tested Positive for Latent Tuberculosis After Secukinumab Initiation

Time frame: Up to approximately 84 months

Number of Patients not Tested for Tuberculosis Before Secukinumab Initiation With Prophylactic Antibiotic Use

Time frame: Approximately 6 months

Number of Patients Without a Tuberculosis Test Before Secukinumab Initiation

Time frame: Approximately 6 months

A Real-world Study of Tuberculosis Incidence in AS, PsA, or PsO Patients Treated With Secukinumab in Brazil

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes