UPTRAVI® (selexipag) overview
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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]
UPTRAVI® in PAH: From pre-clinical development to real-world experience
Based on pre-clinical, clinical and real-world experience[1][2][3][4][5][6][7][8][9][10]
*As measured by a composite primary morbidity-mortality endpoint. Results were driven by a decrease in disease progression and hospitalisations due to PAH; they do not apply to mortality on its own.[5]
Adding UPTRAVI® is recommended at the first sign of intermediate risk[11][12]
Explore the 2015 European Society of Cardiology (ESC)/European Respiratory Society (ERS) guideline recommendations for
®.
Explore the efficacy of UPTRAVI®
The value of early initiation
Proactively initiating UPTRAVI® early can give your patients more time.[13]
Improvement in patient risk status
UPTRAVI® can help your patients with PAH achieve and maintain a low-risk status.[9][14]
The benefits of triple combination
Adding UPTRAVI® in triple combination therapy provides benefits for your patients with PAH.[15]
Beneficial in a broad range of patients
UPTRAVI® can provide beneficial long-term outcomes for a broad range of patients with PAH.[5]
Give your patients with PAH time, add UPTRAVI®
Targeting the prostacyclin pathway with UPTRAVI® can improve long-term outcomes in PAH
Primary endpoint: 40% reduction in the risk of a morbidity-mortality event vs placebo in the
.*[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]
Adding UPTRAVI® in triple combination therapy provides long-term benefits *
When administered in triple combination therapy, UPTRAVI® reduced the risk of a morbidity-mortality event by 37% vs placebo compared with an endothelin receptor antagonist (ERA) and a phosphodiesterase type-5 inhibitor (PDE-5i) alone.*‡[15]
*Post hoc analysis of patients in GRIPHON on background therapy with an ERA and a PDE-5i at baseline.[15]
‡As measured by a composite primary endpoint. Results do not apply to mortality on its own (HR 0.63; 95% CI: 0.44–0.90).[15]
Proactively initiating UPTRAVI® earlier can give your patients even more time
UPTRAVI® reduced the risk of a morbidity-mortality event vs placebo in patients treated early (≤6 months from diagnosis) and those treated later (>6 months after diagnosis), with a greater effect when treated earlier (p=0.0219).*‡[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]
‡As measured by a composite primary endpoint. Results do not apply to mortality on its own.[13]
UPTRAVI® is shown to improve and maintain patient risk status in both clinical and real-world settings
In the GRIPHON trial, UPTRAVI® patients were 69% more likely to increase their number of low-risk criteria vs placebo.*‡[14]
*Post hoc analysis assessing whether treatment with UPTRAVI® improved risk profile from baseline compared with placebo in the GRIPHON population using the non-invasive French approach and REVEAL 2.0.[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]
In the real-world SPHERE registry, 85% of patients improved or maintained their baseline risk status after 1 year.*‡[9]
*From the first 250 patients enrolled in SPHERE, an ongoing US-based observational registry of UPTRAVI®-treated patients with PAH.[9]
‡Based on patients who had risk assessment at both baseline and 1 year (196 patients or 78% of the total population).[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][16]
Explore the full UPTRAVI® efficacy data
Learn more about UPTRAVI®
Safety and tolerability
UPTRAVI® has a well-characterised and generally manageable safety profile.[1][5]
Initiation and dosing
Adding UPTRAVI® is recommended at the first sign of intermediate risk.[11][12]
Expert consensus opinion
Learn about the patient profiles identified as benefiting from early UPTRAVI® initiation.[17]
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.
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; HR, hazard ratio; IP, prostacyclin; OR, odds ratio; PAH, pulmonary arterial hypertension; PDE-5i, phosphodiesterase type-5 inhibitor; WHO, World Health Organization
UPTRAVI® PRESCRIBING INFORMATION AND ADVERSE EVENT REPORTING
OPSUMIT® PRESCRIBING INFORMATION AND ADVERSE EVENT REPORTING
CP-220222 | May 2021