Real World Patient Characteristics and Treatment Patterns From Crizanlizumab Use: Preliminary Analysis From Select Sickle Cell Centers

SEG-2022-01 Patient Characteristics and Treatment Patterns From Early Crizanlizumab Use in Real-world Setting: Preliminary Analysis From Select Sickle Cell Centers

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06662825

Enrollment

376

Registered

2024-10-29

Start date

2022-12-13

Completion date

2023-11-01

Last updated

2024-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Disease

Brief summary

This was a retrospective cohort study using secondary data from member sites of the National Alliance of Sickle Cell Centers (NASCC) with patients who had initiated crizanlizumab between 2019 and 2022.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

* Any patient with a diagnosis of SCD based on high performance liquid chromatography (HPLC) or hemoglobin electrophoresis at treating institution. * Treatment order for crizanlizumab; Index date was defined as the date for the first crizanlizumab treatment. * At least 12 months of available electronic medical record (EMR) data pre-index date (baseline). * Patients must have received at least one dose of crizanlizumab. * For inclusion in pre/post analysis of effectiveness, patients must have received crizanlizumab for at least 12 months.

Exclusion criteria

None identified.

Design outcomes

Primary

Measure	Time frame	Description
Number of Patients by Type of Disease Modifying Therapy (DMT) Received Pre- and Post-index Date	Up to 2 years	Index date was defined as the date of the first crizanlizumab infusion. DMTs included: * Any SCD specific therapy * Hydroxyurea * Voxelotor * L-Glutamine * Other
Number of Patients who Received Long-acting Opioid Medication Before Starting Crizanlizumab	Baseline	—
Number of Patients who Received Chronic Red Blood Cell Transfusion Therapy Before Starting Crizanlizumab Categorized by Duration of Therapy	Baseline	Red blood cell transfusion therapy time intervals: * 0-3 months * 3-6 months * 6-12 months * \>12 months * Unknown
Number of Patients who Received Chronic Red Blood Cell Transfusion Therapy After Starting Crizanlizumab Categorized by Duration of Therapy	Up to 1 year	Red blood cell transfusion therapy time intervals: * 0-3 months * 3-6 months * 6-12 months * \>12 months * Unknown
Age at Index Date	Day 1 of Year 2	Index date was defined as the date of the first crizanlizumab infusion
Gender at Index Date	Day 1 of Year 2	Index date was defined as the date of the first crizanlizumab infusion
Race	Day 1 of Year 2	—
Ethnicity	Day 1 of Year 2	—
Insurance Type at Index Date	Day 1 of Year 2	Index date was defined as the date of the first crizanlizumab infusion
Number of Patients Categorized by Comorbidity	Baseline	—

Secondary

Measure	Time frame	Description
Number of SCD-related Hospitalizations and Emergency Department Visits Pre- and Post-index Date	Up to 2 years	Index date was defined as the date of the first crizanlizumab infusion.
Length of Stay of SCD-related Hospitalization Visits Pre- and Post-index Date	Up to 2 years	Index date was defined as the date of the first crizanlizumab infusion.
Number of Doses Received by Patients Who Continued and Discontinued Crizanlizumab Treatment	1 year	—

Countries

United States

Outcome results