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Characteristics of Patients With Sickle Cell Disease

Characteristics of Patients With Sickle Cell Disease Who Initiate Crizanlizumab Therapy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05494541
Enrollment
540
Registered
2022-08-10
Start date
2021-08-30
Completion date
2021-10-27
Last updated
2022-11-08

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

Conditions

Sickle Cell Disease

Keywords

Crizanlizumab,, sickle cell disease

Brief summary

This was a retrospective descriptive analysis of health care claims data using the IQVIA open source medical and pharmacy claims databases.

Detailed description

Patients with a diagnosis of SCD between November 1, 2018 and April 30, 2021 were identified. Among these patients, those who initiated crizanlizumab between November 1, 2019 and January 31, 2021 (index period) were selected into the treatment cohort. The indexing timeframe allowed for a 1-year lookback period and a minimum of 3 months (3m cohort) of follow-up. A subset of the 3m cohort with 6-months of available (6m cohort) follow-up was performed. The index date was the date of the first crizanlizumab administration. Study period: 01 November 2018 - 30 April 2021 Index period: 01 November 2019 - 31 January 2021 Index date: Date of the first claim for administration of crizanlizumab in the index period

Interventions

Patients who initiated crizanlizumab between November 1, 2019 and January 31, 2021 (index period) were selected into the treatment cohort.

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* At least 1 claim in IQVIA Patient Centric Medical Claims Database (Dx) with SCD diagnosis (ICD-10 D57.xx, except D57.3) within the study period; * At least 1 claim for administration of crizanlizumab within the index period. Index date was the date of first administration; * At least 1 claim with HCPCs for crizanlizumab (J0791) OR with at least one claim for an unspecified biologic (J3590) on the same day as a claim for SCD (ICD-10 D57.xx, except D57.3) OR with at least one claim with HCPCs C9053; * At least 16 years of age on the index date; * Linkage to the IQVIA Longitudinal Prescription Database (LRx) within the study period; * Stability and eligibility in Dx during the 12 months prior to the index date; * Stability and eligibility in LRx during the 12 months prior to the index date

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Number of patients : SCD genotypeBaselineNumber of patients with sickle cell disease genotype were reported.
Number of patients by Charlson Comorbidity Index (CCI) score categoryBaselineSeverity of comorbidity was categorized into three grades: mild, with CCI scores of 1-2; moderate, with CCI scores of 3-4; and severe, with CCI scores ≥5.
Number of patients by comorbidityBaselineNumber of patients by IQVIA's standard comorbidity list were reported.
Number of patients with history of additional SCD-related comorbidities associated with organ damageBaselineNumber of patients with history of additional SCD-related comorbidities associated with organ damage were reported.
Number of patients : History of hydroxyurea useBaselinePre-index treatment history for sickle cell disease was reported.
Number of patients : History of L-glutamine useBaselinePre-index treatment history for sickle cell disease was reported.
Number of patients : History of Voxelotor useBaselinePre-index treatment history for sickle cell disease was reported.
AgeBaselineAge information was reported.
Number of patients: GenderBaselineGender information was reported.
Number of patients: Geographic regionBaselineThe following categories were included: Northeast, Midwest, South, West
Number of patients: Insurance typeBaselineWhen multiple payer types were observed, the following hierarchy was used: Medicare, Commercial, Medicaid, Cash, Unspecifed. When commercially-managed Medicaid was observed, the Medicaid designation was assigned.

Secondary

MeasureTime frameDescription
Number of hydroxyurea claimsThroughout the follow-up period, approximately 1.5 yearsConcomitant SCD treatments after initiating crizanlizumab
Proportion of patients with claims for L-glutamine while on crizanlizumab therapyThroughout the follow-up period, approximately 1.5 yearsConcomitant SCD treatments after initiating crizanlizumab
Number of L-glutamine claimsThroughout the follow-up period, approximately 1.5 yearsConcomitant SCD treatments after initiating crizanlizumab
Proportion of patients with claims for voxelotor while on crizanlizumab therapyThroughout the follow-up period, approximately 1.5 yearsConcomitant SCD treatments after initiating crizanlizumab
Number of voxelotor claimsThroughout the follow-up period, approximately 1.5 yearsConcomitant SCD treatments after initiating crizanlizumab
Proportion of patients with claims for hydroxyurea while on crizanlizumab therapyThroughout the follow-up period, approximately 1.5 yearsConcomitant SCD treatments after initiating crizanlizumab

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026