Baseline patient characteristics2*
Treated ≤6 months from diagnosis
35% (n=404/1156; 52% FC II and 46% FC III)†
Background therapy
- 41%
PDE5i
(n=165/404) - 39%
None
(n=157/404) - 10%
ERA
(n=42/404) - 10%
ERA + PDE5i
(n=40/404)
Time to first disease progression event in patients treated within 6 months of PAH diagnosis (UPTRAVI® vs placebo)2
Summary of primary endpoint events in patients treated within 6 months of PAH diagnosis2
| UPTRAVI® n=207 % (n) | Placebo n=197 % (n) | |||
|---|---|---|---|---|
| PRIMARY COMPOSITE ENDPOINT: Morbidity/mortality up to end of treatment period|| | ||||
| All primary endpoint events | 27.5% (57) | 50.3% (99) | ||
| Hospitalization for PAH | 11.6% (24) | 19.8% (39) | ||
| Other disease progression (decrease in 6MWD plus worsening FC or need for other therapy) | 7.2% (15) | 24.4% (48) | ||
| Death | 6.8% (14) | 5.1% (10) | ||
| Parenteral prostanoid or chronic oxygen therapy | 1.9% (4) | 1.0% (2) | ||
| Need for lung transplantation or balloon atrial septostomy for worsening of PAH | 0% (0) | 0% (0) | ||
The analysis described here is post hoc and exploratory. The subgroup was not prespecified for evaluation of the primary endpoint. Please note this analysis did not compare patients treated within 6 months of PAH diagnosis with patients treated after 6 months of PAH diagnosis. Sample size should be considered and results should be interpreted with caution.
Adverse reactions in ≤6 months from diagnosis subgroup occurring more frequently with UPTRAVI® compared with placebo by ≥3%2
| ADVERSE REACTION | UPTRAVI® n=207 % (n) | Placebo n=196 % (n) |
|---|---|---|
| Headache | 61% (126) | 27% (53) |
| Diarrhea | 32% (67) | 14% (28) |
| Nausea | 23% (48) | 10% (20) |
| Pain in jaw | 16% (34) | 4% (7) |
| Vomiting | 16% (32) | 7% (14) |
| Pain in extremity | 14% (29) | 2% (4) |
| Myalgia | 13% (27) | 7% (14) |
| Arthralgia | 13% (26) | 6% (11) |
| Nasopharyngitis | 10% (21) | 7% (13) |
| Flushing | 8% (17) | 4% (7) |
Baseline patient characteristics2*
Treated >6 months from diagnosis
65% (n=752/1156; 42% FC II and 56% FC III)†
Background therapy
- 28%
PDE5i
(n=209/752) - 11%
None
(n=79/752) - 17%
ERA
(n=128/752) - 45%
ERA + PDE5i
(n=336/752)
Time to first disease progression event in patients treated after 6 months of PAH diagnosis (UPTRAVI® vs placebo)2
Summary of primary endpoint events in patients treated after 6 months of PAH diagnosis2
| UPTRAVI® n=367 % (n) | Placebo n=385 % (n) | |||
|---|---|---|---|---|
| PRIMARY COMPOSITE ENDPOINT: Morbidity/mortality up to end of treatment period|| | ||||
| All primary endpoint events | 26.7% (98) | 37.1% (143) | ||
| Hospitalization for PAH | 14.7% (54) | 18.2% (70) | ||
| Other disease progression (decrease in 6MWD plus worsening FC or need for other therapy) | 6.3% (23) | 13.5% (52) | ||
| Death | 3.8% (14) | 2.1% (8) | ||
| Parenteral prostanoid or chronic oxygen therapy | 1.6% (6) | 2.9% (11) | ||
| Need for lung transplantation or balloon atrial septostomy for worsening of PAH | 0.3% (1) | 0.5% (2) | ||
The analysis described here is post hoc and exploratory. The subgroup was not prespecified for evaluation of the primary endpoint. Please note this analysis did not compare patients treated within 6 months of PAH diagnosis with patients treated after 6 months of PAH diagnosis. Sample size should be considered and results should be interpreted with caution.
Adverse reactions in >6 months from diagnosis subgroup occurring more frequently with UPTRAVI® compared with placebo by ≥3%2
| ADVERSE REACTION | UPTRAVI® n=368 % (n) | Placebo n=381 % (n) |
|---|---|---|
| Headache | 68% (249) | 36% (136) |
| Diarrhea | 48% (177) | 22% (82) |
| Nausea | 39% (145) | 23% (87) |
| Pain in jaw | 31% (114) | 8% (29) |
| Vomiting | 20% (72) | 9% (35) |
| Pain in extremity | 19% (68) | 11% (42) |
| Myalgia | 18% (65) | 5% (20) |
| Flushing | 14% (53) | 6% (22) |
