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OPSUMIT® (macitentan) was studied in SERAPHIN, the largest long-term, outcomes-based pivotal trial of an ERA in PAH1

Long-term outcomes data in both monotherapy AND combination therapy1,2

Trial design1,2:

The effect of OPSUMIT® on disease progression in patients with PAH (WHO Group I) was studied in SERAPHIN, a large (N=742), event-driven, multicenter, long-term (average treatment duration 2 years), randomized, double-blind, placebo-controlled phase 3 trial. At study baseline, 36% of patients were not using PAH-specific background therapy and 64% were using stable background therapy for at least 3 months with PDE-5is or inhaled/oral prostanoids.*

Trial demographics1,3:

  • Patients had predominantly WHO FC II (52%) and FC III (46%) symptoms
  • Etiologies included IPAH/HPAH (57%), PAH-CTD (31%), PAH-CHD with repaired shunts (8%), PAH associated with drugs and toxins (3%), and PAH-HIV (1%)
  • Mean patient age was 46 years, and 77% of patients were female
  • 25% of patients were recently diagnosed (<6 months) and 75% were previously diagnosed (≥6 months)

Trial demographics1

742

Patients were randomized

OPSUMIT® 10 mg: n=242
Macitentan 3 mg: n=250
Placebo: n=250

Macitentan 3 mg is not an approved dose.

Monotherapy and
combination therapy1,3

SERAPHIN study design: baseline monotherapy and combination therapy

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

Learn about the proven efficacy of OPSUMIT®

See Seraphin Results

SERAPHIN PAH-related hospitalization results

View the Data

View SERAPHIN PAH-CTD subgroup data

See the Data

Review the
REPAIR study

DISCOVER THE DATA

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ERA=endothelin receptor antagonist; FC=Functional Class; HPAH=heritable PAH; IPAH=idiopathic PAH; PAH=pulmonary arterial hypertension; PAH-CHD=PAH associated with congenital heart disease; PAH-CTD=PAH associated with connective tissue disease; PAH-HIV=PAH associated with human immunodeficiency virus; PDE-5i=phosphodiesterase type 5 inhibitor; SERAPHIN=Study with an Endothelin Receptor Antagonist in Pulmonary Arterial Hypertension to Improve CliNical Outcome; WHO=World Health Organization.
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. US Dept of Health and Human Services, US Food and Drug Administration, Center for Drug Evaluation and Research. Opsumit® (macitentan) NDA 204410. Accessed October 14, 2022. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204410Orig1s000MedR.pdf

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