Baseline patient characteristics2‡
Patients with PAH-CTD in GRIPHON
29% (n=334/1156)
Subtypes
- 51% PAH-SSc (n=170/334)
- 24.5% (n=82/334)
- 24.5% PAH-MCTD/CTD-Other
(n=82/334)§
FC II 46% (n=154/334)
FC III 53% (n=176/334)
FC I OR IV 1% (n=4/334)
Background therapy
- 28% PDE5i (n=82/334)
- 23% None (n=78/334)
- 20% ERA (n=66/334)
- 29% ERA + PDE5i (n=96/334)
Proven in a Broad Range of Patients1
GRIPHON is the largest PAH pivotal trial, studied as monotherapy, dual therapy (ERA or PDE5i), and triple therapy (ERA + PDE5i)1,2
1156 Patients
UPTRAVI (selexipag):
n=574
Placebo: n=582
Mean age:
48 years
Female:
80%
1.4 Years (median duration of exposure to UPTRAVI)
Longest endpoint evaluation period of any prostacyclin pathway therapy
0.9 Years
Median time from PAH diagnosis in patients taking UPTRAVI
New England Journal of Medicine Clinical Trial Publication for GRIPHON
This article includes information that has not been approved by the Food and Drug Administration for UPTRAVI. 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.
Proven in a Broad Range of Patients1
GRIPHON is the largest PAH pivotal trial, studied as monotherapy, dual therapy (ERA or PDE5i), and triple therapy (ERA + PDE5i)1,2
1156 Patients
UPTRAVI (selexipag):
n=574
Placebo: n=582
Mean age:
48 years
Female: 80%
1.4 Years (median duration of exposure to UPTRAVI)
Longest endpoint evaluation period of any prostacyclin pathway therapy
0.9 Years
Median time from PAH diagnosis in patients taking UPTRAVI
New England Journal of Medicine Clinical Trial Publication for GRIPHON
This article includes information that has not been approved by the Food and Drug Administration for UPTRAVI. 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.
Summary of primary endpoint events in patients with PAH-CTD2
| PRIMARY COMPOSITE ENDPOINT: Morbidity/mortality up to end of treatment period|| | UPTRAVI n=167, % (n) | Placebo n=167, % (n) |
|---|---|---|
| All primary endpoint events | 28.7% (48) | 43.7% (73) |
| FIRST EVENT WAS Hospitalization for PAH | 12.6% (21) | 21.6% (36) |
| Other disease progression (decrease in 6MWD plus worsening FC or need for other therapy) | 6.6% (11) | 17.4% (29) |
| Death | 7.2% (12) | 1.8% (3) |
| Parenteral prostanoid or chronic oxygen therapy | 1.8% (3) | 3.0% (5) |
| Need for lung transplantation or balloon atrial septostomy for worsening of PAH | 0.6% (1) | 0% (0) |
Adverse reactions in the PAH-CTD subpopulation occurring more frequently (≥3%) with UPTRAVI compared with placebo2
| ADVERSE REACTION | UPTRAVI n=167, % (n) | Placebo n=165||, % (n) |
|---|---|---|
| Headache | 62% (104) | 36% (60) |
| Diarrhea | 40% (67) | 26% (42) |
| Nausea | 37% (62) | 25% (41) |
| Dizziness | 21% (35) | 18% (30) |
| Vomiting | 20% (34) | 6% (10) |
| Pain in extremity | 19% (31) | 5% (8) |
| Pain in jaw | 14% (24) | 7% (11) |
| Myalgia | 13% (21) | 6% (10) |
| Arthralgia | 11% (19) | 7% (12) |
| Nasopharyngitis | 11% (19) | 7% (12) |
| Flushing | 11% (19) | 5% (8) |
| Decreased appetite | 10% (17) | 6% (9) |
PAH-CTD was a prespecified subgroup for evaluation of the primary endpoint; however, the more detailed analyses described here are post hoc. Sample size should be considered and results should be interpreted with caution.
Baseline patient characteristics2‡
Patients with PAH-SSc
(of the 334 patients with PAH-CTD in GRIPHON)
51% (n=170/334)
FC II 34% (n=57/170)
FC II 65% (n=110/170)
FC I OR IV 2% (n=3/170)
Background therapy
- 23% PDE5i (n=39/170)
- 22% None (n=38/170)
- 18% ERA (n=31/170)
- 37% ERA + PDE5i (n=62/170)
Proven in a Broad Range of Patients1
GRIPHON is the largest PAH pivotal trial, studied as monotherapy, dual therapy (ERA or PDE5i), and triple therapy (ERA + PDE5i)1,2
1156 Patients
UPTRAVI (selexipag):
n=574
Placebo: n=582
Mean age:
48 years
Female:
80%
1.4 Years (median duration of exposure to UPTRAVI)
Longest endpoint evaluation period of any prostacyclin pathway therapy
0.9 Years
Median time from PAH diagnosis in patients taking UPTRAVI
New England Journal of Medicine Clinical Trial Publication for GRIPHON
This article includes information that has not been approved by the Food and Drug Administration for UPTRAVI. 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.
Proven in a Broad Range of Patients1
GRIPHON is the largest PAH pivotal trial, studied as monotherapy, dual therapy (ERA or PDE5i), and triple therapy (ERA + PDE5i)1,2
1156 Patients
UPTRAVI (selexipag):
n=574
Placebo: n=582
Mean age:
48 years
Female: 80%
1.4 Years (median duration of exposure to UPTRAVI)
Longest endpoint evaluation period of any prostacyclin pathway therapy
0.9 Years
Median time from PAH diagnosis in patients taking UPTRAVI
New England Journal of Medicine Clinical Trial Publication for GRIPHON
This article includes information that has not been approved by the Food and Drug Administration for UPTRAVI. 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.
Summary of primary endpoint events in patients with PAH-SSc2
| PRIMARY COMPOSITE ENDPOINT: Morbidity/mortality up to end of treatment period|| | UPTRAVI n=77, % (n) | Placebo n=93, % (n) |
|---|---|---|
| All primary endpoint events | 32.5% (25) | 49.5% (46) |
| FIRST EVENT WAS Hospitalization for PAH | 13.0% (10) | 23.7% (22) |
| Other disease progression (decrease in 6MWD plus worsening FC or need for other therapy) | 10.4% (8) | 19.4% (18) |
| Death | 5.2% (4) | 1.1% (1) |
| Parenteral prostanoid or chronic oxygen therapy | 2.6% (2) | 5.4% (5) |
| Need for lung transplantation or balloon atrial septostomy for worsening of PAH | 1.3% (1) | 0% (0) |
Adverse reactions in the PAH-SSc subpopulation occurring more frequently (≥3%) with UPTRAVI compared with placebo2
| ADVERSE REACTION | UPTRAVI n=77,% (n) | Placebo n=91‖,% (n) |
|---|---|---|
| Headache | 55% (42) | 34% (31) |
| Diarrhea | 46% (35) | 28% (25) |
| Nausea | 31% (24) | 26% (24) |
| Dizziness | 22% (17) | 18% (16) |
| Pain in extremity | 22% (17) | 4% (4) |
| Pain in jaw | 20% (15) | 8% (7) |
| Back pain | 14% (11) | 7% (6) |
| Myalgia | 12% (9) | 8% (7) |
| Urinary tract infection | 10% (8) | 7% (6) |
| Asthenia | 10% (8) | 4% (4) |
This subgroup analysis was post hoc and exploratory in nature. Sample size should be considered and results should be interpreted with caution.
The evidence adds up
10-YEAR OLE
