Characteristics of Patients With Sickle Cell Disease

Characteristics of Patients With Sickle Cell Disease Who Initiate Crizanlizumab Therapy

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

Study Overview

• Status: Completed
• Conditions: Sickle Cell Disease
• Intervention / Treatment: Other: Crizanlizumab

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

• Study Type: Observational
• Enrollment (Actual): 540

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936-1080
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 99 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study included patients with SCD who initiated crizanlizumab in a real-world setting

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Overall cohort; All the patients who met the base inclusion criteria were included in the cohort.	Other: Crizanlizumab; Patients who initiated crizanlizumab between November 1, 2019 and January 31, 2021 (index period) were selected into the treatment cohort.
Three-month cohort (3m cohort); 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.	Other: Crizanlizumab; Patients who initiated crizanlizumab between November 1, 2019 and January 31, 2021 (index period) were selected into the treatment cohort.
Six-month cohort (6m cohort); 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.	Other: Crizanlizumab; Patients who initiated crizanlizumab between November 1, 2019 and January 31, 2021 (index period) were selected into the treatment cohort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Age information was reported.	Baseline
Number of patients: Gender	Gender information was reported.	Baseline
Number of patients: Geographic region	The following categories were included: Northeast, Midwest, South, West	Baseline
Number of patients: Insurance type	When 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.	Baseline
Number of patients by Charlson Comorbidity Index (CCI) score category	Severity 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.	Baseline
Number of patients by comorbidity	Number of patients by IQVIA's standard comorbidity list were reported.	Baseline
Number of patients with history of additional SCD-related comorbidities associated with organ damage	Number of patients with history of additional SCD-related comorbidities associated with organ damage were reported.	Baseline
Number of patients : History of hydroxyurea use	Pre-index treatment history for sickle cell disease was reported.	Baseline
Number of patients : History of L-glutamine use	Pre-index treatment history for sickle cell disease was reported.	Baseline
Number of patients : History of Voxelotor use	Pre-index treatment history for sickle cell disease was reported.	Baseline
Number of patients : SCD genotype	Number of patients with sickle cell disease genotype were reported.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with claims for hydroxyurea while on crizanlizumab therapy	Concomitant SCD treatments after initiating crizanlizumab	Throughout the follow-up period, approximately 1.5 years
Number of hydroxyurea claims	Concomitant SCD treatments after initiating crizanlizumab	Throughout the follow-up period, approximately 1.5 years
Proportion of patients with claims for L-glutamine while on crizanlizumab therapy	Concomitant SCD treatments after initiating crizanlizumab	Throughout the follow-up period, approximately 1.5 years
Number of L-glutamine claims	Concomitant SCD treatments after initiating crizanlizumab	Throughout the follow-up period, approximately 1.5 years
Proportion of patients with claims for voxelotor while on crizanlizumab therapy	Concomitant SCD treatments after initiating crizanlizumab	Throughout the follow-up period, approximately 1.5 years
Number of voxelotor claims	Concomitant SCD treatments after initiating crizanlizumab	Throughout the follow-up period, approximately 1.5 years

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CSEG101AUS17 from the Novartis Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 30, 2021
• Primary Completion (ACTUAL): October 27, 2021
• Study Completion (ACTUAL): October 27, 2021

Study Registration Dates

• First Submitted: August 8, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (ACTUAL): August 10, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: sickle cell disease; Crizanlizumab,
• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell
• Other Study ID Numbers: CSEG101AUS17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO