UPTRAVI (selexipag) Healthcare Professional (HCP) Website

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GRIPHON Trial Overview

The safety and efficacy of UPTRAVI (selexipag) were demonstrated in a multicenter, double-blind, placebo-controlled, parallel-group, event-driven study in adult patients with symptomatic PAH (>98% WHO FC II or III). The primary endpoint was the time to first disease progression event.¹^,2*

Treatment with UPTRAVI resulted in a 40% risk reduction^† (99% CI: 22% to 54%; P<0.0001; HR 0.60) in disease progression compared with placebo (27% [155/574] vs 41.6% [242/582], respectively)¹^,2
Adverse reactions occurring more frequently (≥5%) on UPTRAVI compared with placebo are headache, diarrhea, jaw pain, nausea, myalgia, vomiting, pain in extremity, and flushing¹

View GRIPHON Trial

*The primary endpoint was the time to first progression event: a) death, b) hospitalization for PAH, c) need for lung transplantation or balloon atrial septostomy for worsening of PAH, d) parenteral prostanoid or chronic oxygen therapy, or e) other disease progression (decrease in 6MWD plus worsening or need of other therapy). ^†Hazard ratio based on primary endpoint events up to the end of treatment.

GRIPHON 10-Year OLE Overview

Limitations

Results of open-label studies are subject to inherent limitations, including the absence of a placebo-control arm, which can introduce bias and affect data interpretation. The low number of patients at later timepoints limits this study to descriptive analyses and should be interpreted with caution. This study did not consider changes in risk category, treatment regimen, or UPTRAVI treatment duration over the long-term follow-up. Dose adjustments were permitted during the open-label extension, but these stayed within the dose group of low, medium, and high. To minimize selection bias, survival analyses were restricted to the 574 patients originally randomized to UPTRAVI in the double-blind study. This is important given that patients assigned to placebo in the double blind could later receive UPTRAVI in the open label, following a morbidity event after completing the double-blind study, potentially skewing long-term outcomes.³

Study Objectives

Assessments included patient characteristics, Kaplan-Meier survival estimates (assessed in the overall population, by individual maintenance dose, and by background therapy and time from diagnosis), and safety and tolerability.³

Time from UPTRAVI initiation to death up to EOT + 30 days³

Kaplan-Meier survival estimates (95% confidence intervals) are shown.

In triple-combination therapy, time from UPTRAVI initiation to death up to EOT + 30 days³

Kaplan-Meier survival estimates (95% confidence intervals) are shown. Does not include 112 patients in the overall population who did not have a PAH-specific background therapy at baseline.

A low personal dose of UPTRAVI (200 mcg to 400 mcg BID) is equally effective as higher personal doses (up to 1600 mcg BID) in a 10-year open-label extension study³

Time from UPTRAVI initiation to death up to EOT + 30 days³

Kaplan-Meier survival estimates (95% confidence intervals) are shown. Does not include 8 patients in the overall population who were on an individualized maintenance dose of UPTRAVI <200 mcg BID and 1 patient whose individualized maintenance dose of UPTRAVI (700/900 mcg BID) did not meet the criteria for “medium” dose.