Author(s)
Dispenzieri A1, Zonder J2, Hoffman J3, Wong SW4, Liedtke M5, Abonour R6, D'Souza A7, Lee C8, Cote S8, Nair S9, Potluri R10, Weiss BM11, Vermeulen J11, Lam A12, Mehra M11
1Mayo Clinic, Rochester, MN, USA, 2Barbara Ann Karmanos Cancer Institute, Detroit, MI, USA, 3Sylvester Comprehensive Cancer Center, Miami, FL, USA, 4University of California, San Francisco, CA, USA, 5Stanford University, Stanford, CA, USA, 6Indiana Cancer Pavilion, Indianapolis, IN, USA, 7Froedtert & Medical College of Wisconsin Cancer Center, Milwaukee, WI, USA, 8Janssen Global Services, Raritan, NJ, USA, 9Janssen Pharmaceutica NV, Beerse, Belgium, 10SmartAnalyst Inc., New York, NY, USA, 11Janssen Global Medical Affairs, Horsham, PA, USA, 12Janssen Global Services, LLC, Raritan, NJ, USA
OBJECTIVES: To characterize AL amyloidosis patients and treatment patterns using US real-world data. METHODS: Data were extracted from Optum EHR and Clinformatics Data Mart (claims) databases. Eligible patients (≥18 years) had an AL amyloidosis or amyloidosis diagnosis on/after January 1, 2008 (based on ICD-9/ICD-10 codes) and ≥1 line of therapy (LOT) comprising ≥1 prespecified treatments. Continuous medical enrollment during the 365 days (claims) or first active date ≥365 days (EHR) prior to index amyloidosis diagnosis were required; other cancers in the 365 days prior to index amyloidosis diagnosis were not permitted. LOTs were defined by start/end dates and a distinct regimen (≥1 drugs). Patients may have multiple sequential LOTs during follow-up. Comorbidities were scored according to the Charlson Comorbidity Index (CCI). Descriptive statistics are provided for patient characteristics at index diagnosis for patients with ≥1 LOT, regimen distributions per LOT, treatment attrition, and treatment duration per LOT and by regimen. RESULTS: Data from 1688 patients (claims, n=624; EHR, n=1064) meeting the inclusion criteria were analyzed. Median age at diagnosis was 67 years, 55.7% were male; almost 70% had an index diagnosis between 2013─2019. Median CCI score at index diagnosis was 1; 10.9% had a stem cell transplant on/after index diagnosis date. Most common comorbidities: hypertension (50.8%), renal (26.2%), congestive heart failure (24.6%). Median follow-up: 28 months. Most common LOT1 treatment regimen was a proteasome inhibitor (PI)+alkylating agent+steroid (23.2%), specifically bortezomib+cyclophosphamide+dexamethasone (VCd; n=358). Steroid-only (dexamethasone) and PI±steroid regimens accounted for 16.4% and 13.2% of LOT1, respectively. CONCLUSIONS: Findings were consistent with clinical guidelines and real-world data showing that VCd is currently the most commonly used initial therapy regimen for AL amyloidosis, supporting its choice as the most relevant comparator in ongoing clinical trials in this patient population. Limitations include the use of assumptions to classify AL amyloidosis vs other amyloidosis types.
Conference/Value in Health Info
2021-05, ISPOR 2021, Montreal, Canada
Value in Health, Volume 24, Issue 5, S1 (May 2021)
Code
PRO78
Topic
Health Service Delivery & Process of Care
Topic Subcategory
Treatment Patterns and Guidelines
Disease
Drugs
