A Study to Evaluate Treatment Patterns and Effectiveness of Luspatercept

Prior treatment

• 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

Other

• Lacking relevant unstructured documents in the Flatiron database for review by the abstraction team

• 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