Abstract Rationale Current guidelines recommend adding parenteral prostacyclin, such as treprostinil, or an activin-signaling inhibitor in addition to an endothelin-1 receptor antagonist and a phosphodiesterase-5 inhibitor for intermediate-high risk patients with pulmonary arterial hypertension (PAH); parenteral prostacyclin is currently recommended for all high-risk PAH patients. In an era of quadruple therapy, there have been reports of PAH therapy de-escalation. This analysis aimed to analyze changes in real-world dosing of Remodulin (parenteral treprostinil). Methods This was a longitudinal, cross-sectional analysis that used outpatient Remodulin shipment records from U.S. specialty pharmacies, and included patients with the first shipment between January 1, 2018 to March 26, 2024 (pre-sotatercept availability) and March 27, 2024 to October 16, 2025 (post-sotatercept availability). Median Remodulin doses were assessed separately during pre- and post-sotatercept availability periods. Results are reported as median (IQR). Results During pre-sotatercept availability, Remodulin real-world doses were 31 (20, 46) ng/kg/min at month of treatment (MOT)3 and 40 (27, 58) ng/kg/min at MOT6; after sotatercept became available, Remodulin doses were 31 (21, 48) ng/kg/min at MOT3 and 40 (28, 60) ng/kg/min at MOT6 (Table 1). Doses of IV treprostinil were higher than SC at MOT3 35 (21, 50) vs 30 (20, 45) ng/kg/min but were similar to SC at MOT6 40 (29, 60) vs 40 (25, 57) ng/kg/min before sotatercept became available. After sotatercept availability, similar trends were observed with higher IV treprostinil doses compared to SC doses at MOT3 34 (20, 50) vs 31 (21, 43) ng/kg/min and similar doses at MOT6 40 (26, 60) vs 40 (28, 60) ng/kg/min. Conclusion Real-world outpatient Remodulin dosing remained similar both before and after sotatercept became available. Limitations of this analysis are the lack of longer-term Remodulin dosing data and unknown sotatercept utilization. The lack of dose changes could be reflective of sotatercept utilization after prostacyclin therapy. The use of Remodulin remains clinically relevant for PAH patients irrespective of sotatercept availability. This abstract is funded by: United Therapeutics Corporation
Le et al. (Fri,) studied this question.