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

TuBerculosis Incidence in AS, PsA or Pso Patients Treated With Secukinumab: Real World Evidence in Brazilian Environment (ToBeReal)

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 Overview

• Status: Terminated
• Conditions: Tuberculosis

• Study Type: Observational
• Enrollment (Actual): 152

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Novartis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Ankylosing Spondylitis (AS) Cohort; Adult patients diagnosed with AS who were treated with secukinumab.
Psoriatic Arthritis (PsA) Cohort; Adult patients diagnosed with PsA who were treated with secukinumab.
Psoriasis (PsO) Cohort; Adult patients diagnosed with PsO who were treated with secukinumab.
Overall Cohort; Adult patients diagnosed with AS, PsA, or PsO who were treated with secukinumab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to approximately 84 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic: Age		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	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.	Up to approximately 84 months
Number of Patients per Demographic Category	Demographic categories included gender and ethnicity.	Baseline
Demographic: Time to Follow-up From Secukinumab Initiation		Up to approximately 84 months
Number of Patients With Comorbidities up to Secukinumab Initiation		Baseline
Number of Patients per Comorbidity		Baseline
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 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	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	Up to approximately 84 months
Duration of Interruption of Secukinumab Treatment	Interruption duration: interruption date of secukinumab minus restart date of secukinumab.	Up to approximately 84 months
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2021
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: November 28, 2024
• First Submitted That Met QC Criteria: November 28, 2024
• First Posted (Estimated): December 4, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: November 28, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Psoriasis; Psoriatic arthritis; Ankylosing spondylitis
• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: CAIN457FBR03