Characteristics of Patients With Sickle Cell Disease

Novartis

Status: Completed

Conditions: Sickle Cell Disease

Treatments: Other: Crizanlizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT05494541

CSEG101AUS17

Details and patient eligibility

About

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

Full 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

Enrollment: 540 patients

Sex: All

Ages: 16 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

540 participants in 3 patient groups

Overall cohort

Description:

All the patients who met the base inclusion criteria were included in the cohort.

Treatment:

Other: Crizanlizumab

Three-month cohort (3m cohort)

Description:

Patients with stability and eligibility in IQVIA Patient Centric Medical Claims Database (Dx) and stability and eligibility in IQVIA Longitudinal Prescription Database (LRx) during the 3 months following the index date were included in the cohort.

Treatment:

Other: Crizanlizumab

Six-month cohort (6m cohort)

Description:

A subset of patients from the 3m cohort with stability and eligibility in Dx and stability and eligibility in LRx during the 6 months following the index date were included in this cohort.

Treatment:

Other: Crizanlizumab