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Uptravi® (SelexiPag): tHe usErs dRug rEgistry (SPHERE) - A US-Based, Prospective Drug Registry of Selexipag in Clinical Practice

Murali Chakinala


Anna Hemnes


Kristin Highland


Nick H. Kim

Harrison Farber


Kelly Chin


Michael Keating

Carol Zhao

B. K. Hartline

Vallerie McLaughlin


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Conference: 2017 PH Professional Network Symposium

Release Date: 10.06.2017

Presentation Type: Abstracts

File Download: 2017 PHPN Abstract 1009

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Abstract presented at the 2017 PH Professional Network Symposium held in Bethesda, MD on October 5-7, 2017

Purpose

To describe the design and objectives of the SPHERE registry.

Background

Uptravi® (selexipag) is an oral, selective IP prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to delay disease progression and reduce the risk of hospitalization for PAH. In the Phase III GRIPHON trial of 1,156 patients with PAH, selexipag significantly reduced the risk of occurrence of the primary outcome composite of morbidity or mortality by 40% compared with placebo (Sitbon et al. N Engl J Med, 2015). Based on these data, selexipag was approved by the FDA in December of 2015. SPHERE will report data from routine clinical practice including disease characteristics, clinical outcomes, and dosing regimens of patients treated with selexipag.

Methods

SPHERE is a US, multicenter, prospective, real-world observational registry that will enroll approximately 500 patients with PAH (from approximately 75 centers) who initiate selexipag at the time of enrollment or who have been receiving treatment with selexipag and have a documented titration regimen. Patients who have previously been treated with selexipag as part of a clinical trial or who have discontinued selexipag will be excluded from the registry. Patients currently enrolled in a blinded clinical trial or trial of an unapproved drug will also be excluded. Data will be gathered from electronic medical records from routine clinical practice on a quarterly basis and will be collected for up to 18 months from the date of enrollment.

Results

The main objectives of SPHERE are to describe: (1) disease characteristics; (2) dosing regimens and titration; and (3) the clinical course of patients being treated with selexipag. Adverse events and serious adverse events will also be collected during the observation period. Data analysis will be conducted for all patients as well as separately for patients who newly initiated selexipag treatment, and who had previously initiated selexipag at the time of enrollment. Dosing regimens, including titration and maintenance doses, will be described. Transitions from or to a prostacyclin (intravenous/subcutaneous, oral, or inhaled) will be analyzed. Clinical course will be evaluated by survival time, death related to PAH, change in WHO functional class, 6-minute walk distance, hemodynamic measurements, and vital signs. Analyses will be adjusted for covariates including PAH prognostic factors and prior PAH therapies.

Conclusion

SPHERE will describe disease characteristics, characterize dosing regimens and titration, and the clinical course and outcomes in patients treated with selexipag in a real-world setting.