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SERAPHIN: Primary endpoint in overall study population*
OPSUMIT® (macitentan) significantly reduced the risk of disease progression by 45% vs placebo1
The primary endpoint in the SERAPHIN trial was time to the first occurrence of death, a significant morbidity event, defined as atrial septostomy, lung transplantation, initiation of IV or SC prostanoids, or clinical worsening of PAH (defined as all of the following: a sustained ≥15% decrease from baseline in 6MWD,† worsening of PAH symptoms,‡ and need for additional PAH treatment) during double-blind treatment plus 7 days.1,2
Kaplan-Meier estimates of risk of first primary endpoint event in SERAPHIN1,2
Summary of primary endpoint events1
OPSUMIT® 10 mg (n=242), n (%) |
Placebo (n=250), n (%) |
|
---|---|---|
Patients with a primary endpoint event§ | 76 (31.4) | 116 (46.4) |
Component as first event | ||
Worsening PAH | 59 (24.4) | 93 (37.2) |
Death | 16 (6.6) | 17 (6.8) |
Initiation of IV/SC prostanoids | 1 (0.4) | 6 (2.4) |
The beneficial effect of OPSUMIT® was primarily attributable to a reduction in clinical worsening events (defined as all of the following: a sustained ≥15% decrease from baseline in 6MWD,† worsening of PAH symptoms [a decline in WHO FC], and need for additional PAH treatment).
§No patients experienced an event of lung transplantation or atrial septostomy in the placebo or OPSUMIT® 10 mg treatment groups.
OPSUMIT® can be started as monotherapy or in combination with PDE-5is or inhaled prostanoids.1ǁ
ǁOPSUMIT® is approved in combination with PDE-5is or inhaled prostanoids, but not oral prostanoids.1
Combination therapy exploratory subgroup analysis in SERAPHIN trial
Kaplan-Meier estimates of risk of primary endpoint event when OPSUMIT® was added to stable PAH-specific background therapy1,3
At baseline, 64% of enrolled patients were treated with a stable dose of PAH-specific background therapy (61% PDE-5is; 6% inhaled or oral prostanoids).1ǁ
ǁOPSUMIT® is approved in combination with PDE-5is or inhaled prostanoids, but not oral prostanoids.1
Kaplan-Meier estimates of risk of first primary endpoint event1,3,4
¶Not adjusted for multiplicity.
Summary of primary endpoint events in patients treated with PAH-specific background therapy4
OPSUMIT® 10 mg (n=154), n (%) |
Placebo (n=154), n (%) |
|
---|---|---|
Patients with a primary endpoint event§ | 50 (32.5) | 68 (44.2) |
Component as first event | ||
Worsening PAH | 39 (25.3) | 58 (37.7) |
Death | 10 (6.5) | 6 (3.9) |
Initiation of IV/SC prostanoids | 1 (0.6) | 4 (2.6) |
§No patients experienced an event of lung transplantation or atrial septostomy in the placebo or OPSUMIT® 10 mg treatment groups.
Common adverse reactions in the combination therapy exploratory subgroup5#
OPSUMIT® 10 mg n=154 |
Placebo n=153 |
|
---|---|---|
Anemia | 16.2% | 4.6% |
Nasopharyngitis | 11.0% | 10.5% |
Bronchitis | 11.0% | 5.9% |
Headache | 13.6% | 10.5% |
Diarrhea | 13.0% | 9.8% |
#More frequent than placebo by ≥3%.
Combination therapy exploratory subgroup safety2,5
- The safety profile of OPSUMIT® as part of a combination therapy regimen was consistent with that of OPSUMIT® in the overall SERAPHIN population
- The incidence of peripheral edema, a known ERA-related adverse event, was similar in patients receiving background therapy who were treated with OPSUMIT® and placebo (19.5% and 23.5%, respectively)
- Treatment discontinuations due to adverse events in patients receiving background therapy were similar in those receiving OPSUMIT® and those receiving placebo (9.1% and 11.8%, respectively)
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*All randomized patients.
†Confirmed by a 6-minute walk test performed on a different day within 2 weeks.
‡Worsening of PAH included at least one of the following: Advancing to a higher FC from baseline (or no change in WHO FC IV) and signs of right heart failure that does not respond to oral diuretic treatment.