Myelodysplastic Syndromes (MDS)
Conditions
Keywords
Myelodysplastic syndromes (MDS)
Brief summary
The purpose of this study is to understand the treatment patterns and clinical outcomes of myelodysplastic syndromes patients treated with luspatercept or erythropoiesis-stimulating agents
Interventions
DRUGLuspatercept
As per product label
As per product label
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Included in the Flatiron Health Broad Research Network, with 2 or more visits after January 1, 2011 * Has evidence of diagnosis with myelodysplastic syndromes (MDS) after Jan 1, 2020, as identified by a natural language processing (NLP)-based machine-learning (ML) model * Has evidence of diagnosis with MDS as identified via structured International Classification of Diseases (ICD) codes: * International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM): D46.x * International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM): 238.7x * Age ≥ 18 years at MDS diagnosis * Has either ring sideroblasts positive or negative status, as confirmed by bone marrow aspirate lab results or clinician notes * Has at least one confirmed structured activity more than 8 weeks prior to the index date Cohort specific inclusion criteria: First-line (1L) luspatercept cohort * Has evidence of receipt of luspatercept as identified via structured data as evidenced by non-cancelled Medication Order or Medication Administration and confirmed via unstructured data * Has evidence of treatment with luspatercept for at least 12 weeks as evidenced by non-cancelled Medication Orders or Medication Administrations 1L erythropoiesis stimulating agents (ESA) cohort: * Has evidence of receipt of any ESA (i.e., epoetin alfa, darbepoetin alfa, epoetin beta, epoetin alfa-epbx, epoetin zeta, or epoetin beta-methoxy polyethylene glycol) for at least 12 weeks as evidenced by non-cancelled Medication Orders or Medication Administrations * Note: this criterion is included to maximize alignment between the 1L ESA cohort and the 1L luspatercept cohort and minimize bias induced by the dosage requirement in the 1L luspatercept cohort Second-lin (2L) luspatercept cohort: * Has evidence of receipt of luspatercept as identified via structured data as evidenced by non-cancelled Medication Order or Medication Administration and confirmed via unstructured data * Has evidence of receipt of at least 1 ESA as evidenced by a non-cancelled medication order or medication administration prior to the date of initial luspatercept receipt * Has evidence of treatment with luspatercept for at least 12 weeks as evidenced by non-cancelled Medication Orders or Medication Administrations
Exclusion criteria
* Lacking relevant unstructured documents in the Flatiron database for review by the abstraction team * Have been exposed to any of the following MDS-related therapy prior to luspatercept initiation in the 1L and 2L settings or ESA initiation in the 1L setting: lenalidomide, azacitidine, decitabine, cedazuridine, eltrombopag, cytarabine, daunorubicin, idarubicin, filgrastim, pegfilgrastim, lipefilgrastim, sargramostim, venetoclax, or has evidence of a stem cell transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant baseline demographics | Baseline | — |
| Luspatercept dose at treatment initiation | Baseline | Cohort 1 and 3 only |
| Luspatercept dose at treatment discontinuation | Up to 50 months | Cohort 1 and 3 only |
| Luspatercept dose change or escalation or reduction | Up to 50 months | Cohort 1 and 3 only |
| Time from luspatercept initiation to the first occurrence of dose escalation | Up to 50 months | Cohort 1 and 3 only |
| Proportion of participants that discontinued treatment | Up to 50 months | — |
| Time from treatment initiation to treatment discontinuation | Up to 50 months | — |
| Time from luspatercept/erythropoiesis stimulating agents treatment initiation to initiation of a new treatment for myelodysplastic syndromes | Up to 50 months | — |
Countries
United States
Outcome results
None listed