To estimate the incidence rates of kidney-related clinical outcomes among patients with tuberous sclerosis complex (TSC)-related angiomyolipoma (AML) compared to an age-matched control cohort in the United States.
Materials and Methods
This was a retrospective, observational study. Administrative data from the MarketScan Research Databases were used to select patients with TSC and renal AML. An age-matched group with no TSC or renal AML was identified for comparison. Outcomes were incidence rates per 100 patient-years and number of months to development of hematuria, chronic kidney disease, renal hemorrhage, kidney failure, and inpatient death.
Results
Among the commercially insured TSC-renal AML patients (N = 605) and matched controls (N = 1815), 37.2% were <18 years old. Among Medicaid TSC-renal AML patients (N = 246) and matched controls (N = 738), 38.6% were aged <18. In the commercial sample, in both age groups (<18 and ≥18), the incidence rate of each clinical outcome measured was higher in the TSC-renal AML cohort than in the control cohort, with several differences reaching statistical significance. Compared with younger patients, older TSC-renal AML patients had higher incidence rates of clinical outcomes (hematuria: 20.4 vs 8.7; chronic kidney disease: 9.6 vs 3.5; renal hemorrhage 2.7 vs 0.7; kidney failure: 1.9 vs 0.4) and took less time on average to develop each clinical outcome. A similar pattern of results was observed among patients with Medicaid insurance.
Conclusion
TSC-renal AML patients are at significantly higher risk for renal morbidity relative to the general population.
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Financial Disclosure:Judith Prestifilippo and Zhimei Liu are employees of and stockholders at Novartis. John Bissler, John Hulbert, and Hearns Charles were paid consulting fees by Novartis for their contributions to this study. Xue Song, Katherine Cappell, and Christopher Gregory are employees of Truven Health Analytics, which was paid by Novartis to conduct this study and to develop this paper. All authors, including those employed by the study sponsor, participated in the collection, analysis, and interpretation of data; writing the report; and the decision to submit the report for publication.
Funding Support:This study was funded byNovartis Pharmaceuticals Corporation.
