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UPTRAVI® (selexipag) is an oral selective prostacyclin (IP) receptor agonist that is distinct from prostacyclin and its analogues, with a higher selectivity for the IP receptor vs other prostanoid receptors. Stimulation of the IP receptor by UPTRAVI® and its active metabolite leads to vasodilatory as well as anti-proliferative and anti-fibrotic effects.[1]

UPTRAVI® was approved by the European Medicines Agency (EMA) in 2016 for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with World Health Organization (WHO) functional class (FC) II–III. UPTRAVI® can be used as either a combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type-5 inhibitor (PDE-5i), or as monotherapy in patients who cannot tolerate these medications. Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.[1]

1.0_uptravi_graph00

Based on pre-clinical, clinical and real-world experience[1][2][3][4][5][6][7][8][9][10]

*Composite primary endpoint; results do not apply to mortality on its own.[5]

Explore the efficacy of UPTRAVI®

The efficacy and safety of UPTRAVI® were investigated in GRIPHON, the largest outcomes trial conducted in PAH to date.[5][6] Explore the trial data to find out how UPTRAVI® can delay disease progression and give your patients more time.

The value of early initiation

Plan from the start to add UPTRAVI® within 6 months of diagnosis for patients not fully at low risk on dual therapy.[13]

Improvement in patient risk status

UPTRAVI® can help your patients with PAH achieve and maintain a low-risk status vs baseline.[9][14]

The benefits of triple combination

Prevent disease progression events by adding UPTRAVI® early and targeting the three PAH pathways[15][16]

Effective in a broad range of patients

UPTRAVI® can provide beneficial long-term outcomes for a broad range of patients with PAH.[5]

Use UPTRAVI® to give your PAH patients more time

Uptravi_home_graph1

Adding UPTRAVI® can delay disease progression for PAH patients

Primary endpoint: 40% reduction in the risk of a morbidity-mortality event vs placebo in the GRIPHON trial.*[5]

*Composite primary endpoint; results do not apply to mortality on its own; (HR 0.60; 99% CI: 0.46–0.78; p<0.001).[5]

Uptravi_home_graph3

Triple combination therapy including UPTRAVI® provides long-term benefits

When administered in triple combination therapy, UPTRAVI® reduced the risk of disease progression by 37% vs placebo compared with an ERA and a PDE-5i alone.*‡[15]

*Post hoc analysis of patients in GRIPHON on background therapy with an ERA and a PDE-5i at baseline.[15]
Composite primary endpoint; results do not apply to mortality on its own; (HR 0.63; 95% CI: 0.44–0.90).[15]


Uptravi_home_graph3

Early initiation of UPTRAVI® improves long-term outcomes to a greater degree vs later initiation

UPTRAVI® reduced the risk of a morbidity-mortality event vs placebo by 55% patients treated early (≤6 months from diagnosis) and by 26% in those treated later (>6 months after diagnosis), with a greater effect when treated earlier (p=0.0219).*Patients diagnosed earlier were more likely to be in WHO FC II compared with those diagnosed later.§[13]

*Post hoc analysis in time-from-diagnosis subgroups in GRIPHON. Early: (HR 0.45; 95% CI: 0.33–0.63), later: (HR 0.74; 95% CI: 0.57–0.96).[13]
Composite primary endpoint; results do not apply to mortality on its own.[13]
§At baseline, 52.0% of patients diagnosed in ≤6 months were in WHO FC II, while 42.4% of patients diagnosed later were in WHO FC II.[13]


UPTRAVI® helps to improve and maintain patient risk status in both clinical and real-world settings

Uptravi_home_graph4

In the GRIPHON trial, patients receiving UPTRAVI® were 69% more likely to increase their number of low-risk criteria vs placebo.*[14]

*Post hoc analysis assessing the effect of UPTRAVI® on risk profile from baseline to Week 26 compared with placebo in the GRIPHON population using both the non-invasive French registry and REVEAL 2.0 risk assessment methods.[14]
Change in number of low-risk criteria over time in the non-invasive French risk assessment subgroup (OR 1.69; 95% CI: 1.28–2.24; p=0.0002).[14]

uptravi_home_graph5

In the real-world SPHERE registry, 77% of patients receiving UPTRAVI® improved or maintained their baseline risk status after 18 months.*[9]

(This SPHERE analysis includes data from patients outside the therapeutic indications for UPTRAVI®; some markets may not be able to refer to this claim. If the market allows, the data may be switched to the poster by Farber H et al. Presented at ATS 2019 [Poster no. 10769])

*From the first 500 patients enrolled in SPHERE, an ongoing US-based observational registry of UPTRAVI®-treated patients with PAH.[9]
Based on patients who had a risk assessment at both baseline and 18 months (78% of the total population). Data include a minority of patients outside the therapeutic indication for UPTRAVI®, including WHO FC I and WHO FC IV patients (n=51), patients from WHO PH groups 2–5 (n=26), as well as patients with PAH outside the indication (HIV [n=4], portal hypertension [n=18]).[9]


The overall treatment goal in PAH is to achieve a low-risk status,[11] which is shown to be prognostic for better long-term outcomes.[9][14][17]

Explore the full UPTRAVI® efficacy data

Learn more about UPTRAVI®

Safety and tolerability

UPTRAVI® has a predictable and manageable safety profile.[1][5]

Initiation and dosing

Adding UPTRAVI® is recommended for patients not fully at low risk with ERA + PDE-5i.[11][12]

Expert consensus opinion

Learn about the patient profiles identified as benefiting from UPTRAVI® initiation.[18]

Explore Janssen's PAH therapies

Built on ground-breaking innovation and an unwavering commitment to patients, we have created a range of therapeutic solutions to support patients throughout their PAH journey.

Explore Janssen's PAH therapies

CI, confidence interval; EMA, European Medicines Agency; ERA, endothelin receptor antagonist; ERS, European Respiratory Society; ESC, European Society of Cardiology; FC, functional class; FDA, Food and Drug Administration; HIV, human immunodeficiency virus; HR, hazard ratio; IP, prostacyclin; IV, intravenous; OR, odds ratio; PAH, pulmonary arterial hypertension; PDE-5i, phosphodiesterase type 5 inhibitor; PH, pulmonary hypertension; WHO, World Health Organization

UPTRAVI® PRESCRIBING INFORMATION AND ADVERSE EVENT REPORTING

OPSUMIT® PRESCRIBING INFORMATION AND ADVERSE EVENT REPORTING


CP-344255 | September 2022

CP-344255 - September 2022