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Abstract: PO1538

Early Findings of Patients with Autosomal Dominant Polycystic Kidney Disease Initiating Tolvaptan in the United States: A Claims-Based Analysis

Session Information

Category: Genetic Diseases of the Kidneys

  • 1001 Genetic Diseases of the Kidneys: Cystic

Authors

  • Cosmatos, Irene, United BioSource LLC, Blue Bell, Pennsylvania, United States
  • Tao, Sunning, United BioSource LLC, Blue Bell, Pennsylvania, United States
  • Dieck, Gretchen S., United BioSource LLC, Blue Bell, Pennsylvania, United States
  • Julian, Michele L., United BioSource LLC, Blue Bell, Pennsylvania, United States
  • Wilt, Timothy, Otsuka Pharmaceutical Development and Commercialization Inc, Princeton, New Jersey, United States
  • Pareja, Kristin, Otsuka Pharmaceutical Development and Commercialization Inc, Princeton, New Jersey, United States
  • Sanon, Myrlene, Otsuka Pharmaceutical Development and Commercialization Inc, Princeton, New Jersey, United States
Background

Autosomal dominant polycystic kidney disease (ADPKD) is the most common hereditary kidney disease. Tolvaptan (Jynarque®), the first and only approved treatment for ADPKD in the United States (US), has been shown to slow kidney function decline in clinical trials. An understanding of characteristics of the real-world patients initiating treatment with tolvaptan in the US is needed.

Methods

An observational, retrospective analysis assessing baseline measures was conducted among patients with ADPKD who had initiated treatment with tolvaptan from 14 May 2018 through 9 January 2020 in the US. Data were obtained by linking the Symphony Health Integrated Dataverse (IDV), a nationally representative billing database, with Specialty Pharmacy (SP) data from the tolvaptan Risk Evaluation and Mitigation Strategy (REMS), which is a mandatory program for patients prescribed tolvaptan to treat ADPKD. The study index date was the date of first shipment of tolvaptan. Descriptive analyses were conducted on the following baseline measures: demographics, comorbidities, and disease characteristics. All measures were identified within the 6-month period prior to the index date in the Symphony Health IDV. For patients with more than 1 CKD stage diagnosis during the baseline period, the CKD stage closest to the index date was captured.

Results

The study sample included 4,355 patients. The mean age at tolvaptan initiation was 48.8 years (Standard Deviation: 12.3), with 51.7% (n=2,251) female. Hypertension was the most commonly observed comorbidity (n=3,520, 80.8%), followed by diabetes (n=273, 6.3%). The distribution of CKD stage, available for 1,566 (36.0%) patients during their baseline period, was: 6.2% (n=97) in CKD Stage I, 13.4% (n=210) in CKD Stage II, 55.2% (n=864) in CKD Stage III, 22.9% (n=359) in CKD Stage IV, and 2.3% (n=36) in CKD stage V.

Conclusion

This is one of the first real-world studies to describe comorbidities and disease characteristics in patients with ADPKD initiating tolvaptan in the US. Stage III was the most commonly reported CKD stage among patients with a known CKD stage during their baseline period. Additional analyses evaluating the real-life impact of tolvaptan on clinical outcomes, healthcare utilization, and quality of life are needed.

Funding

  • Commercial Support