For U.S. Healthcare Professionals

Contact your
Local MSL
 Request A Medical Science
Liaison (MSL)
Contact your
Local MSL
 Request A Medical Science
Liaison (MSL)

PAH-related hospitalization

OPSUMIT® (macitentan) reduced the risk of PAH-related hospitalization1,2

A key secondary endpoint in SERAPHIN was death due to PAH or PAH-related hospitalization.

There was a 50% reduction in the risk of PAH-related hospitalization vs placebo in the overall population.*

Kaplan-Meier estimates of risk of first key secondary endpoint event1,2

Key secondary SERAPHIN endpoint: risk of PAH-related hospitalization graph

Summary of death due to PAH and hospitalization due to PAH1,2

  OPSUMIT®
 10 mg
(n=242), 
n (%)		 Placebo
(n=250), n (%)
Death due to PAH or hospitalization for PAH 50 (20.7) 84 (33.6)
Component as first event
Death due to PAH 5 (2.1) 5 (2.0)
Hospitalization for PAH 45 (18.6) 79 (31.6)

Exploratory subgroup analysis: Combination therapy results

The combination therapy data below represent an exploratory analysis. Results should be interpreted with caution.

Kaplan-Meier estimates of risk of first key secondary endpoint event when OPSUMIT® was added to stable PAH-specific background therapy3

  • 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). OPSUMIT® is approved in combination with PDE-5is or inhaled prostanoids, but not oral prostanoids1

Kaplan-Meier estimates of risk of first key secondary endpoint event3

Combination therapy exploratory analysis: combination therapy results graph

Summary of death due to PAH and hospitalization due to PAH3

  OPSUMIT®
 10 mg
(n=154), 
n (%)		 Placebo
(n=154), n (%)
Death due to PAH or hospitalization for PAH 37 (24.0) 49 (31.8)
Component as first event
Death due to PAH 2 (1.3) 2 (1.3)
Hospitalization for PAH 35 (22.7) 47 (30.5)

Common adverse reactions in the combination therapy exploratory subgroup4‡

  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 safety2-4

  • 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)

*All randomized patients.

†Not adjusted for multiplicity.

Looking for patient enrollment resources?

Enroll Patients

Access the
video library

Watch Videos

Review the
REPAIR study

DISCOVER THE DATA

BACK TO TOP

CI=confidence interval; ERA=endothelin receptor antagonist; HR=hazard ratio; PAH=pulmonary arterial hypertension; PDE-5i=phosphodiesterase type 5 inhibitor; SERAPHIN=Study with an Endothelin Receptor Antagonist in Pulmonary Arterial Hypertension to Improve CliNical Outcome.
References: 1. OPSUMIT® [prescribing information]. Actelion Pharmaceuticals US, Inc. 2. Pulido T, Adzerikho I, Channick RN, et al; SERAPHIN Investigators. Macitentan and morbidity and mortality in pulmonary arterial hypertension. N Engl J Med. 2013;369(9):809-818 and suppl 1-21. doi:10.1056/NEJMoa1213917 3. Data on file. Actelion Pharmaceuticals US, Inc. 4. Jansa P, Pulido T. Macitentan in pulmonary arterial hypertension: a focus on combination therapy in the SERAPHIN trial. Am J Cardiovasc Drugs. 2018;18:1-11.

To report suspected adverse reactions, contact Janssen at 1-800-JANSSEN (1-800-526-7736), or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Contact Medical Information

THIS SITE IS INTENDED FOR U.S. AUDIENCES ONLY.
©2023 Actelion Pharmaceuticals US, Inc. 
cp-136843v11 10/23

EXPAND +

+ +