OBJECTIVE: Hypertension was common in randomized controlled trials (RCTs) of voclosporin, an oral calcineurin inhibitor approved in 2021 to treat lupus nephritis (LN); however, increases in blood pressure (BP) diminished after 4 weeks. Here, we characterize BP changes in real-world data. METHODS: We used electronic health record data from U.S. practices. We calculated time from first voclosporin prescription to a minimal clinically important increase (MCID) in systolic (10-mmHg) or diastolic (5-mmHg) BP, and the mean change in BP between baseline and windows of 0-1, 1-2, 2-3, 3-6, 6-9, and 9-12 months after starting treatment. Analyses were stratified by baseline BP as normal (<130 mmHg systolic and <80 mmHg diastolic), elevated (130-164 mmHg systolic or 80-104 mmHg diastolic and not high), or high (≥165 mmHg systolic or ≥105 mmHg diastolic). RESULTS: Among 287 patients (mean age, 41.4; 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) mmHg. Overall, 60.3% experienced a systolic MCID within a median of 90 (95% CI: 70-102) days; 60.6% 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) mmHg for those with normal, elevated, and high BP at baseline. CONCLUSIONS: Our results may differ because of differences in the intensity of BP management or the higher prevalence of cardiovascular risk factors in U.S. PATIENTS: More intensive BP management with voclosporin treatment for LN might be warranted.
Roberts et al. (Mon,) studied this question.