Uptravi Found to Reduce Risk, by Half, of PAH Disease Progression

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by Marisa Wexler MS |

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Early treatment with Janssen’s Uptravi (selexipag) can halve the risk of disease progression for people with pulmonary arterial hypertension (PAH), a new analysis found.

The results showed patients treated with Uptravi within six months of PAH diagnosis saw their risk of disease progression reduced by 52% compared with a placebo, according to Janssen.

“This analysis reinforces the role of selexipag [Uptravi] in early treatment escalation to help reduce the risk of disease progression and improve long-term outcomes for people living with PAH,” Alessandro Maresta, MD, vice president and head of medical affairs for the pulmonary hypertension therapeutic area at Janssen, said in a press release.

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Data from two now-completed Phase 3 clinical trials — GRIPHON (NCT01106014) and TRITON (NCT02558231), both of which compared oral Uptravi with a placebo — were analyzed.

The analysis involved data from 649 patients who had started the trial within six months of being diagnosed with PAH. Of them, 329 were given Uptravi and 320 received a placebo. Most participants also were being treated with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase 5 inhibitor (PDE5i), two types of targeted therapies for pulmonary hypertension.

Researchers conducted a post hoc analysis — that is, an analysis designed and carried out after a study’s data already has been collected — to assess the effect of treatment on disease progression. In the trials, progression was defined by criteria such as substantial worsening of physical ability, hospitalization, or a need for additional medications.

According to the results, when compared with a placebo, treatment with Uptravi significantly reduced the risk of disease progression, by 52%. In total, 67 participants (20%) given Uptravi experienced disease progression, compared with 116 (36%) who received the placebo.

An additional analysis considering only the subset of participants who were on both an ERA and a PDE5i — which was 44% of the total participants — showed similar results. Among these patients, Uptravi reduced the risk of disease progression by 48%, compared with the placebo.

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Uptravi is an oral medication that works by mimicking the activity of prostacyclin, a hormone that triggers blood vessels to relax, which leads blood pressure to decrease. It is approved in the U.S. to delay disease progression in patients with PAH.

These new results “support the principle of earlier treatment escalation with therapies targeting the prostacyclin pathway, such as selexipag, if we are to prevent disease progression events and improve long-term patient outcomes,” said Gerry Coghlan, MD, a consultant cardiologist at The Royal Free Hospital in London.

“PAH is a rare, progressive and life-threatening condition for which there is no cure. Preventing disease progression and maintaining low-risk status for PAH patients is therefore vitally important, and proactive treatment planning is essential to effectively utilize available therapies,” Coghlan added.

A new formulation of Uptravi, delivered by infusion into the bloodstream, was recently approved in the U.S. to help stop interruptions in treatment when patients can’t take oral medicine.