Voclosporin and Changes in Blood Pressure: An Analysis of Real-World Data.

Abstract

Hypertension was common in randomized controlled trials of voclosporin, an oral calcineurin inhibitor approved in 2021 to treat lupus nephritis (LN); however, increases in blood pressure (BP) diminished after four weeks. Here, we characterize BP changes in real-world data. We used electronic health record data from US practices. We calculated time from first voclosporin prescription to a minimum clinically important increase (MCID) in systolic (10 mm Hg) or diastolic (5 mm Hg) BP and the mean change in BP between baseline and windows of 0 to 1, 1 to 2, 2 to 3, 3 to 6, 6 to 9, and 9 to 12 months after starting treatment. Analyses were stratified by baseline BP as normal (<130 mm Hg systolic and <80 mm Hg diastolic), elevated (130-164 mm Hg systolic or 80-104 mm Hg diastolic and not high), or high (≥165 mm Hg systolic or ≥105 mm Hg diastolic). Among 287 patients (mean age 41.4 years; 83.6% women; 32.1% Black, 24.0% White, 17.1% Hispanic, and 5.6% Asian), mean baseline BP was 126/79 (SD 16/11) mm Hg. Overall, 60.3% experienced a systolic MCID within a median of 90 (95% confidence interval [CI] 70-102) days and 60.6% experienced a diastolic MCID within a median of 88 days (95% CI 72-111). Mean BP changes in the first month were 13.7 (±18.6)/6.0 (±13.8), 2.7 (±18.8)/-0.6 (±11.2), and 7.9 (±17.8)/-7.3 (±16.5) mm Hg for those with normal, elevated, and high BP at baseline. Our results may differ because of differences in the intensity of BP management or the higher prevalence of cardiovascular risk factors in US patients. More intensive BP management with voclosporin treatment for LN might be warranted.