Real-World Evidence Supports Efficacy and Safety of Selexipag in Patients With Pulmonary Arterial Hypertension

Research published in The Journal of Heart and Lung Transplantation provides real-world evidence of the effectiveness and safety of selexipag in patients with pulmonary arterial hypertension (PAH), showing stable or improved functional class and risk category outcomes regardless of maintenance dose.

Recent analyses have shown that patients receiving triple therapy for PAH have lower mortality rates compared with those on dual or monotherapy, indicating the importance of combination therapy for achieving low-risk status. Real-world evidence from patient registries provides valuable data on patient demographics, treatment practices, and outcomes in routine clinical practice.

SPHERE was a US-based, multicenter observational registry for selexipag, enrolling adult patients in November 2016 and following them for up to 18 months. Patients were categorized as newly initiated if they began selexipag within or less than 60 days before enrollment and previously initiated if they started more than 60 days before enrollment. Data collection included patient demographics, medical history, dosing regimens, outcomes, and safety information.

The protocol aimed to enroll 500 patients but was expanded to 800 and included only newly initiated patients starting in January 2018. Data were collected every 3 months at routine clinic visits, with no study-mandated procedures. Follow-up continued for 18 months after enrollment, focusing on patients with PAH.

In a registry with 829 patients, the majority had PAH, with over half categorized as World Health Organization functional class 3/4 and intermediate or high risk per the REVEAL 2.0 system. Discontinuation rates for adverse events after 18 months varied among the different patient groups, while survival rates were notably high. Most patients showed stability or improvement in functional class and risk category status over this period. Discontinuation due to adverse events, hospitalization, and survival were consistent across patients with different selexipag maintenance doses, and no new safety concerns were found.

“In this real-world analysis of patients initiating selexipag, most patients had stable or improved FC and REVEAL 2.0 risk category,” said researchers. “Similar to the GRIPHON trial, outcomes with selexipag in this real-world study were comparable across maintenance dose strata, with no new safety signals.”

Reference
McLaughlin V, Farber HW, Highland KW, et al. Disease characteristics, treatments, and outcomes of patients with pulmonary arterial hypertension treated with selexipag in real-world settings from the SPHERE registry (SelexiPag: tHe usErs dRug rEgistry). J Heart Lung Transplant. 2024;43(2):272-283. doi:10.1016/j.healun.2023.09.016