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

NCT05833022

Enrollment

297

Registered

2023-04-27

Start date

2021-07-30

Completion date

2022-04-18

Last updated

2023-04-27

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 at least five patients who initiated crizanlizumab. Patients who were prescribed crizanlizumab were included in the cohort.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Inclusion criteria

* Any patient with 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 at least 6 doses of medication. The rates could be annualized if total post-index time was \<12 months.

Exclusion criteria

None specified

Design outcomes

Primary

Measure	Time frame
Percentage of patients who received sickle cell disease treatment (use of hydroxyurea, l-glutamine, chronic transfusion therapy, and voxelotor) prior to treatment with crizanlizumab	Up to 12 months
Percentage of patients who received sickle cell disease treatment (use of hydroxyurea, l-glutamine, chronic transfusion therapy, and voxelotor) during treatment with crizanlizumab	Up to 12 months

Secondary

Measure	Time frame
Number of SCD-related emergency department (ED) visits	Up to 24 months
Reasons for early discontinuation of crizanlizumab treatment	Up to 24 months
Number of doses of crizanlizumab for patients who discontinued treatment with crizanlizumab	Up to 24 months
Number of patients who discontinued treatment with crizanlizumab	Up to 24 months
Number of sickle cell disease (SCD)-related hospitalizations	Up to 24 months

Countries

United States

Outcome results