Baseline patient characteristics4
Background therapy: ERA + PDE5i
33% (n=376/1156; 31% FC II and 68% FC III)‡Etiology
- 64% IPAH/HPAH (n=242/376)
- 26% PAH-CTD (n=96/376)
- 5% PAH-CHD (n=20/376)
- 5% Other§ (n=18/376)
Time from diagnosis (mean)
- UPTRAVI: 4 years
- Placebo: 3.6 years
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 receiving ERA + PDE5i at baseline4
| PRIMARY COMPOSITE ENDPOINT: Morbidity/mortality up to end of treatment period|| | UPTRAVI n=179, % (n) | Placebo n=197, % (n) |
|---|---|---|
| All primary endpoint events | 26.3% (47) | 40.6% (80) |
| FIRST EVENT WAS Hospitalization for PAH | 15.1% (27) | 21.8% (43) |
| Other disease progression (decrease in 6MWD plus worsening FC or need for other therapy) | 6.1% (11) | 11.2% (22) |
| Death | 2.2% (4) | 1.5% (3) |
| Parenteral prostanoid or chronic oxygen therapy | 2.8% (5) | 5.1% (10) |
| Need for lung transplantation or balloon atrial septostomy for worsening of PAH | 0% (0) | 1.0% (2) |
Adverse reactions in triple-combination subgroup occurring more frequently with UPTRAVI compared with placebo by ≥3%4
| ADVERSE REACTION | UPTRAVI n=179,% (n) | Placebon=197,% (n) |
|---|---|---|
| Headache | 76% (136) | 39% (76) |
| Diarrhea | 56% (100) | 26% (52) |
| Nausea | 48% (85) | 25% (49) |
| Pain in jaw | 41% (74) | 10% (20) |
| Vomiting | 24% (42) | 11% (21) |
| Pain in extremity | 23% (41) | 10% (20) |
| Flushing | 20% (36) | 8% (16) |
| Myalgia | 13% (24) | 4% (8) |
| Bronchitis | 12% (21) | 9% (17) |
Baseline patient characteristics4
Background therapy in FC II patients: ERA + PDE5i
10% (n=115/1156)Etiology
- 70% IPAH/HPAH (n=80/115)
- 18% PAH-CTD (n=21/115)
- 6% PAH-CHD (n=7/115)
- 6% Other§ (n=7/115)
Time from diagnosis (mean)
- UPTRAVI: 4.3 years
- Placebo: 3.6 years
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 FC II patients receiving ERA + PDE-5i at baseline4
| PRIMARY COMPOSITE ENDPOINT: Morbidity/mortality up to end of treatment period|| | UPTRAVI n=55, % (n) | Placebo n=60, % (n) |
|---|---|---|
| All primary endpoint events | 10.9% (6) | 30.0% (18) |
| FIRST EVENT WAS Hospitalization for PAH | 5.5% (3) | 13.3% (8) |
| Other disease progression (decrease in 6MWD plus worsening FC or need for other therapy) | 1.8% (1) | 8.3% (5) |
| Death | 1.7% (1) | 1.7% (1) |
| Parenteral prostanoid or chronic oxygen therapy | 3.6% (2) | 5.0% (3) |
| Need for lung transplantation or balloon atrial septostomy for worsening of PAH | 0% (0) | 1.7% (1) |
Adverse reactions in FC II triple-combination subgroup occurring more frequently (≥3%) with UPTRAVI compared with placebo4
| ADVERSE REACTION | UPTRAVI n=55,% (n) | Placebo n=60,% (n) |
|---|---|---|
| Headache | 78% (43) | 30% (18) |
| Diarrhea | 58% (32) | 13% (8) |
| Nausea | 55% (30) | 20% (12) |
| Pain in jaw | 38% (21) | 5% (3) |
| Vomiting | 24% (13) | 12% (7) |
| Pain in extremity | 15% (8) | 7% (4) |
| Flushing | 16% (9) | 8% (5) |
| Myalgia | 15% (8) | 2% (1) |
| Fatigue | 15% (8) | 10% (6) |
| Bronchitis | 13% (7) | 8% (5) |
| Abdominal pain | 15% (8) | 8% (5) |
| Decreased appetite | 11% (6) | 5% (3) |
Baseline patient characteristics4
Background therapy in FC III patients: ERA + PDE5i
22% (n=255/1156)Etiology
- 61% IPAH/HPAH (n=156/255)
- 29% PAH-CTD (n=75/255)
- 5% PAH-CHD (n=13/255)
- 4% Other§ (n=11/255)
Time from diagnosis (mean)
- UPTRAVI: 3.9 years
- Placebo: 3.6 years
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 (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 FC III patients receiving ERA + PDE-5i at baseline4
| PRIMARY COMPOSITE ENDPOINT: Morbidity/mortality up to end of treatment period|| | UPTRAVI n=122, % (n) | Placebo n=133, % (n) |
|---|---|---|
| All primary endpoint events | 33.6% (41) | 44.4% (59) |
| FIRST EVENT WAS Hospitalization for PAH | 19.7% (24) | 24.8% (33) |
| Other disease progression (decrease in 6MWD plus worsening FC or need for other therapy) | 8.2% (10) | 12.0% (16) |
| Death | 3.3% (4) | 1.5% (2) |
| Parenteral prostanoid or chronic oxygen therapy | 2.5% (3) | 5.3% (7) |
| Need for lung transplantation or balloon atrial septostomy for worsening of PAH | 0% (0) | 0.75% (1) |
Adverse reactions in FC III triple-combination subgroup occurring more frequently (≥3%) with UPTRAVI compared with placebo4
| ADVERSE REACTION | UPTRAVI n=122,% (n) | Placebo n=133,% (n) |
|---|---|---|
| Headache | 75% (91) | 43% (57) |
| Diarrhea | 54% (66) | 31% (41) |
| Nausea | 43% (53) | 27% (36) |
| Pain in jaw | 43% (52) | 12% (16) |
| Vomiting | 23% (28) | 10% (13) |
| Pain in extremity | 26% (32) | 12% (16) |
| Flushing | 21% (26) | 8% (11) |
| Myalgia | 13% (16) | 5% (7) |
Patients receiving an ERA and a PDE5i 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.
The evidence adds up
SEE THE PAH-CTD DATA
