Pivotal trial overall population: Probability of hospitalization event1*
Percentage of patients hospitalized for PAH as a first event occurring as part of the composite endpoint1
13.6%
p>(n=78)
UPTRAVI®
18.7%
v
(n=109)
GRIPHON Trial
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STUDY DESIGN
GRIPHON Is the Largest PAH Pivotal Trial With the Longest Endpoint Evaluation Period of Any Prostacyclin Pathway Therapy1-3
- Multicenter, long-term, double-blind, placebo-controlled, parallel-group, event-driven, phase 3 trial1,4
Study Design1-3
1156 PATIENTS Largest PAH pivotal trial UPTRAVI" (selexipag): n-574 | Placebo: n-582
1.4 YEARS (median duration of UPTRAVI*) Longest endpoint evaluation period of any prostacyclin pathway therapy
Baseline Patient Characteristics1,5
- Mean age: 48 years
- Female: 80%
- Median time from PAH diagnosis in patients taking UPTRAVI®: 0.9 years
ETIOLOGY
IPAH/HPAH 58%
PAH-CHD 10%
PAH-CTD 29%
Other 3%*
NEARLY 1/2 OF ALL PATIENTS WERE FC II
WHO FC II 46%
FC I (0.8%) + FC IV (1%)
WHO FC III 53%
80% ON PAH BACKGROUND THERAPY
ERA + PDE5i33%
PDE5i 32%
ERA 15%
None 20%
This article includes information that has not been approved by the Food and Drug Administration for UPTRAVI® (selexipag). Please see full Prescribing Information available on this website. Authors[s] of this article have received remuneration from Actelion Pharmaceuticals US, Inc., or its affiliates.
*Other=drugs and toxins (2%) and HIV (1%).
6MWD=6-minute walk distance; ERA=endothelin receptor antagonist; FC=Functional Class; GRIPHON=Prostacyclin (PGI2) Receptor Agonist In Pulmonary Arterial HypertensiON; HIV=human immunodeficiency virus; HPAH=heritable PAH; IPAH=idiopathic PAH; PAH-CHD=PAH associated with congenital heart disease with repaired shunts; PAH-CTD=PAH associated with connective tissue disease; PDE5i=phosphodiesterase type-5 inhibitor; WHO=World Health Organization.
1. UPTRAVI® (selexipag) full Prescribing Information. Actelion Pharmaceuticals US, Inc. 2. Sitbon O, Gomberg-Maitland M, Granton J, et al. Clinical trial design and new therapies for pulmonary arterial hypertension. Eur Respir J. 2019;53(1):1801908. doi:10.1183/13993003.01908-2018 3. Data on file. Actelion Pharmaceuticals US, Inc. Length and Population Size of PAH Pivotal Trials Confirmation. June 2024. 4. Sitbon O, Channick R, Chin KM, et al. Selexipag for the treatment of pulmonary hypertension. N Engl J Med. 2015;373:2522-2533 and suppl. 5. Data on file. Actelion Pharmaceuticals US, Inc. GRIPHON Baseline Characteristics Study Report.
