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Characteristics of Patients With Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT05494541
Recruitment Status : Completed
First Posted : August 10, 2022
Last Update Posted : November 8, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment
Sickle Cell Disease 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 Design
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Study Type : Observational
Actual Enrollment : 540 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Characteristics of Patients With Sickle Cell Disease Who Initiate Crizanlizumab Therapy
Actual Study Start Date : August 30, 2021
Actual Primary Completion Date : October 27, 2021
Actual Study Completion Date : October 27, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Age [ Time Frame: Baseline ]
    Age information was reported.

  2. Number of patients: Gender [ Time Frame: Baseline ]
    Gender information was reported.

  3. Number of patients: Geographic region [ Time Frame: Baseline ]

    The following categories were included:

    Northeast, Midwest, South, West


  4. Number of patients: Insurance type [ Time Frame: Baseline ]

    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.


  5. Number of patients by Charlson Comorbidity Index (CCI) score category [ Time Frame: Baseline ]
    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.

  6. Number of patients by comorbidity [ Time Frame: Baseline ]
    Number of patients by IQVIA's standard comorbidity list were reported.

  7. Number of patients with history of additional SCD-related comorbidities associated with organ damage [ Time Frame: Baseline ]
    Number of patients with history of additional SCD-related comorbidities associated with organ damage were reported.

  8. Number of patients : History of hydroxyurea use [ Time Frame: Baseline ]
    Pre-index treatment history for sickle cell disease was reported.

  9. Number of patients : History of L-glutamine use [ Time Frame: Baseline ]
    Pre-index treatment history for sickle cell disease was reported.

  10. Number of patients : History of Voxelotor use [ Time Frame: Baseline ]
    Pre-index treatment history for sickle cell disease was reported.

  11. Number of patients : SCD genotype [ Time Frame: Baseline ]
    Number of patients with sickle cell disease genotype were reported.


Secondary Outcome Measures :
  1. Proportion of patients with claims for hydroxyurea while on crizanlizumab therapy [ Time Frame: Throughout the follow-up period, approximately 1.5 years ]
    Concomitant SCD treatments after initiating crizanlizumab

  2. Number of hydroxyurea claims [ Time Frame: Throughout the follow-up period, approximately 1.5 years ]
    Concomitant SCD treatments after initiating crizanlizumab

  3. Proportion of patients with claims for L-glutamine while on crizanlizumab therapy [ Time Frame: Throughout the follow-up period, approximately 1.5 years ]
    Concomitant SCD treatments after initiating crizanlizumab

  4. Number of L-glutamine claims [ Time Frame: Throughout the follow-up period, approximately 1.5 years ]
    Concomitant SCD treatments after initiating crizanlizumab

  5. Proportion of patients with claims for voxelotor while on crizanlizumab therapy [ Time Frame: Throughout the follow-up period, approximately 1.5 years ]
    Concomitant SCD treatments after initiating crizanlizumab

  6. Number of voxelotor claims [ Time Frame: Throughout the follow-up period, approximately 1.5 years ]
    Concomitant SCD treatments after initiating crizanlizumab


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study included patients with SCD who initiated crizanlizumab in a real-world setting
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05494541


Locations
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United States, New Jersey
Novartis Investigative Site
East Hanover, New Jersey, United States, 07936-1080
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Additional Information:

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05494541    
Other Study ID Numbers: CSEG101AUS17
First Posted: August 10, 2022    Key Record Dates
Last Update Posted: November 8, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Crizanlizumab,
sickle cell disease
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn