Characteristics of Patients With Sickle Cell Disease

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

Detailed Description
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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

Official Title
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Characteristics of Patients With Sickle Cell Disease Who Initiate Crizanlizumab Therapy

Conditions
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Sickle Cell Disease

Intervention / Treatment
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* Other: Crizanlizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crizanlizumab,, sickle cell disease