The information below is from a post hoc subgroup analysis of the GRIPHON trial.
View the GRIPHON pivotal data for context of the overall population.
Patients receiving an ERA and a PDE-5i at baseline were a prespecified subgroup for evaluation of the GRIPHON primary endpoint; however, the more detailed analyses described on this page are exploratory and post hoc. Sample size should be considered and results should be interpreted with caution
Post Hoc SUBGROUP Analysis: 37% Risk Reduction of Disease Progression in Patients TREATED WITH UPTRAVI® + ERA + PDE-5i1-3
Baseline patient characteristics
- 33% (n=376) of all patients in GRIPHON were receiving an ERA and a PDE-5i at baseline (31% FC II and 68% FC III)*
- Etiology in triple-combination subgroup: IPAH/HPAH (64%), PAH-CTD (26%), PAH-CHD (5%), other (5%)
Notable differences from overall population
The triple-combination subgroup had:
- Longer time from diagnosis (3.8 years vs 2.4 years in the overall population)
- Larger percentage from Western Europe/Australia (53% vs 28%)
- Larger percentage from North America (29% vs 17%)
Time to first disease progression event
The treatment effect was established early and maintained over the entire treatment period
Events in patients receiving ERA + PDE-5i at baseline
Adverse reactions in triple-combination subgroup notably different from overall population‡
- Tolerability was generally consistent with overall population
- The most common adverse reactions were headache, diarrhea, nausea, and jaw pain
- Similar to the overall population, treatment-related adverse reactions were more frequent during titration
Post Hoc Subpopulation Analysis: 64% Risk Reduction of Disease Progression in FC II Patients already receiving ERA + PDE-5i1-3
Baseline patient characteristics
- 10% (n=115) of all patients in GRIPHON were FC II and receiving an ERA and a PDE-5i at baseline
- Etiology in FC II triple-combination subpopulation: IPAH/HPAH (70%), PAH-CTD (18%), PAH-CHD (6%), other (6%)
Notable differences from overall population
The FC II triple-combination subpopulation had:
- Longer time from diagnosis (4 years vs 2.4 years in the overall population)
- Larger percentage from Western Europe/Australia (43% vs 28%)
- Larger percentage from North America (31% vs 17%)
Time to first disease progression event in FC II patients
receiving ERA + PDE-5i at baseline
Events in FC II patients receiving ERA + PDE-5i at baseline
Adverse reactions in FC II triple-combination subpopulation notably different from overall population§
- Tolerability was generally consistent with overall population
- Similar to the overall population, treatment-related adverse reactions were more frequent during titration
Post Hoc Subpopulation Analysis: 26% Risk Reduction of Disease Progression in FC III Patients already receiving ERA + PDE-5i1-3
Baseline patient characteristics
- 22% (n=255) of all patients in GRIPHON were FC III and receiving an ERA and a PDE-5i at baseline
- Etiology in FC III triple-combination subpopulation: IPAH/HPAH (61%), PAH-CTD (29%), PAH-CHD (5%), other (4%)
Notable differences from overall population
The FC III triple-combination subpopulation had:
- Longer time from diagnosis (3.8 years vs 2.4 years in the overall population)
- Larger percentage from Western Europe/Australia (57% vs 28%)
- Larger percentage from North America (27% vs 17%)
- Older average age (52 years vs 48.1 years)
Time to first disease progression event in FC III patients
receiving ERA + PDE-5i at baseline
Events in FC III patients receiving ERA + PDE-5i at baseline
Adverse reactions in FC III triple-combination subpopulation notably different from overall population‖
- Tolerability was generally consistent with overall population
- Similar to the overall population, treatment-related adverse reactions were more frequent during titration
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