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OPSUMIT® (macitentan): Additional endpoints from the SERAPHIN trial

SERAPHIN included secondary and exploratory endpoints from baseline to Month 6

Change from baseline in 6MWD1,2

At Month 6, 6MWD had increased by a mean of 12.5 m in the group receiving OPSUMIT® 10 mg (n=242); 6MWD decreased by a mean of 9.4 m in the placebo group (n=249) (placebo-corrected mean increase of 22.0 m; 97.5% CI, 3.0-41.0; P=0.0078).

Change in 6MWD at Month 6

Additional endpoints from SERAPHIN: improvements in 6MWD at month 6

Changes from baseline in WHO FC1,2

At Month 6, 22% of patients in the OPSUMIT® 10 mg group (n=242) experienced improvement of at least 1 WHO FC vs 13% of patients in the placebo group (n=249) P=0.006.

% Patients with improvement of at least
 1 WHO FC at Month 6

Additional endpoints from SERAPHIN: improvements in WHO FC

Changes from baseline in hemodynamic parameters at Month 62-4

Exploratory hemodynamic substudy within SERAPHIN (OPSUMIT®: n=57, placebo: n=67).

PVR*

37%

median reduction
in PVR vs
placebo

(95% CI, 22-49)

Mean PVR at BL
for OPSUMIT®:
924 ± 532 dyn•sec/cm5†

 

Cardiac Index*

0.6

L/min/m2
median increase
in cardiac index vs placebo

(95% CI, 0.3-0.9)

Mean cardiac index
at BL for OPSUMIT®:
2.55 ± 0.85 L/min/m2†

*Not adjusted for multiplicity.

†Plus-minus values are mean ± standard deviation.

SERAPHIN PAH-related hospitalization results

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View SERAPHIN PAH-CTD subgroup data

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6MWD=6-minute walk distance; BL=baseline; CI=confidence interval; FC=Functional Class; PVR=pulmonary vascular resistance; SERAPHIN=Study with an Endothelin Receptor Antagonist in Pulmonary Arterial Hypertension to Improve CliNical Outcome; WHO=World Health Organization.
References: 1. 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 2. OPSUMIT® [prescribing information]. Actelion Pharmaceuticals US, Inc. 3. Galiè N, Jansa P, Pulido T, et al. SERAPHIN haemodynamic substudy: the effect of the dual endothelin receptor antagonist macitentan on haemodynamic parameters and NT-proBNP levels and their association with disease progression in patients with pulmonary arterial hypertension. Eur Heart J. 2017;38(15):1147-1155. 4. Data on file. Actelion Pharmaceuticals US, Inc.

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.

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