Add UPTRAVI® Earlier as Part of Comprehensive Treatment for FC II and FC III PAH1,2
TREATMENT Recommendations
2022 ESC/ERS GUIDELINES: UPTRAVI® is the only prostacyclin pathway therapy to receive the highest class recommendation (Class I, Level B) for sequential triple- and dual-combination therapy2
THE 6TH WORLD SYMPOSIUM ON PULMONARY HYPERTENSION: Escalation to triple-combination therapy is recommended when the initial treatment approach with double-combination therapy results in an intermediate risk status5
In appropriate patients with PAH, guidelines and evidence support earlier escalation to triple-combination therapy2,5*
*The 2022 ESC/ERS Guidelines recommend adding UPTRAVI® for patients without cardiopulmonary comorbidities who are at intermediate-low risk despite receiving ERA/PDE-5i therapy. In these patients, switching from a PDE-5i to riociguat may be considered. In patients who present as intermediate-high or high risk on oral therapies, also consider adding UPTRAVI® or switching from a PDE-5i to riociguat if it is not feasible to add IV or SC prostacyclin analogs.
ERA=endothelin receptor antagonist; ERS=European Respiratory Society; ESC=European Society of Cardiology; FC=Functional Class; IV=intravenous; PDE-5i=phosphodiesterase type-5 inhibitor; SC=subcutaneous.
References:1. UPTRAVI® (selexipag) full Prescribing Information. Actelion Pharmaceuticals US, Inc. 2. Humbert M, Kovacs G, Hoeper MM, et al; ESC/ERS Scientific Document Group. 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: the Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS). Eur Heart J. 2022;43(38):3618-3731. 3. Data on file. Janssen Pharmaceuticals, Inc. Based on Express Scripts Pharmacy Benefit Manager Claims Data and Optum Clinformatics Extended Data Mart. June 2022. 4. Data on file. HUB/SP Janssen Pharmaceuticals, Inc. April 2022. 5. Galiè N, Channick RN, Frantz RP, et al. Risk stratification and medical therapy of pulmonary arterial hypertension. Eur Respir J. 2019;53(1):1801889. doi:10.1183/13993003.01889-2018
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After the starting dose of 200 mcg twice daily, all patients completed titration to their maintenance dose within the first 12 weeks, up to a maximum dose of 1600 mcg twice daily.
Primary endpoint: time to first PAH disease progression event
Death
Hospitalization for PAH
Need for lung transplantation or balloon atrial septostomy for worsening of PAH
Parenteral prostanoid or chronic oxygen therapy
Other disease progression (decrease in 6MWD plus worsening of FC or need for other therapy)
*Other=drugs and toxins (2%) and HIV (1%).
6MWD=6-minute walk distance; ERA=endothelin receptor antagonist; FC=Functional Class; GRIPHON=Prostacyclin (PGI2) Receptor Agonist In Pulmonary Arterial HypertensiON; HIV=human immunodeficiency virus; HPAH=heritable PAH; IPAH=idiopathic PAH; PAH-CHD=PAH associated with congenital heart disease with repaired shunts; PAH-CTD=PAH associated with connective tissue disease; PDE-5i=phosphodiesterase type-5 inhibitor; WHO=World Health Organization.
References: 1. UPTRAVI® (selexipag) full Prescribing Information. Actelion Pharmaceuticals US, Inc. 2. Ruopp NF, Cockrill BA. Diagnosis and treatment of pulmonary arterial hypertension: a review. JAMA. 2022;327(14):1379-1391. 3. Sitbon O, Channick R, Chin KM, et al. Selexipag for the treatment of pulmonary arterial hypertension. N Engl J Med. 2015;373:2522-2533. 4. Coghlan JG, Channick R, Chin K, et al. Targeting the prostacyclin pathway with selexipag in patients with pulmonary arterial hypertension receiving double combination therapy: insights from the randomized controlled GRIPHON study. Am J Cardiovasc Drugs. 2018;18(1):37-47.
UPTRAVI® WAS STUDIED IN GRIPHON, A LARGE OUTCOMES TRIAL IN PAH (N=1156)1
After the starting dose of 200 mcg twice daily, all patients completed titration to their maintenance dose within the first 12 weeks, up to a maximum dose of 1600 mcg twice daily.
Primary endpoint: time to first PAH disease progression event
Death
Hospitalization for PAH
Need for lung transplantation or balloon atrial septostomy for worsening of PAH
Parenteral prostanoid or chronic oxygen therapy
Other disease progression (decrease in 6MWD plus worsening of FC or need for other therapy)
*Other=drugs and toxins (2%) and HIV (1%).
6MWD=6-minute walk distance; ERA=endothelin receptor antagonist; FC=Functional Class; GRIPHON=Prostacyclin (PGI2) Receptor Agonist In Pulmonary Arterial HypertensiON; HIV=human immunodeficiency virus; HPAH=heritable PAH; IPAH=idiopathic PAH; PAH-CHD=PAH associated with congenital heart disease with repaired shunts; PAH-CTD=PAH associated with connective tissue disease; PDE-5i=phosphodiesterase type-5 inhibitor; WHO=World Health Organization.
Reference: 1. UPTRAVI® (selexipag) full Prescribing Information. Actelion Pharmaceuticals US, Inc.