This article is part of Pulmonology Advisor‘s coverage of the CHEST 2019 meeting, taking place in New Orleans, LA. Our staff will report on medical research related to asthma, COPD, critical care medicine, and more conducted by experts in the field. Check back regularly for more news from CHEST 2019.
NEW ORLEANS — Twice-daily selexipag was associated with improvements in 6-minute walk distance (6MWD) and potential maintenance or improvement in World Health Organization functional class (WHO FC) in patients with pulmonary arterial hypertension (PAH), according to findings from the SPHERE trial presented at the CHEST Annual Meeting 2019, held October 19 to 23, 2019, in New Orleans, Louisiana.
The SPHERE trial (ClinicalTrials.gov Identifier: NCT03278002) is multicenter, prospective registry that began in November 2016. Patients with PAH who were actively treated with selexipag (either newly starting selexipag ≤60 days before enrollment or previously receiving selexipag at enrollment with a documented titration regimen) were enrolled. Although the enrollment target is set at 800 patients, a total of 250 patients at data cutoff (December 20, 2018) were included in these results. Clinical assessments were conducted at time of selexipag initiation and were compared with assessments performed 18 months later.
During the median follow-up time of 17.8 months, 191 of the first 250 patients discontinued the study: 137 patients discontinued because of study completion, 22 patients discontinued for other reasons, and 32 patients died. A total of 97% of patients had PAH at time of diagnosis (WHO Group 1), with idiopathic and connective tissue disease-associated etiologies representing the most common PAH types (54% and 30%, respectively).
WHO FC 2 or 3 disease was reported in 28% and 55% of patients, respectively. The median time receiving selexipag before enrollment in the 76% of patients who previously started the drug was 9.2 months (interquartile range [IQR], 6.0-11.7 months). Overall, the median on-study treatment duration was 15.7 months (IQR, 7.8-17.8 months). The median time to reach the twice-daily median maintenance dose of 1200 μg selexipag (IQR, 800-1600 μg) was 8.1 weeks (IQR, 5.6-10.8 weeks).
Of the 117 patients with available FC data at 18 months, approximately 62% of patients maintained their WHO FC, and 25% had improvements in FC. Approximately 13% of patients had worsened FC at 18 months. The median 6MWD was 315 meters (IQR, 211-406 m; n=207), with a change of +7 meters (IQR, -30 to 38 m) in the median 6MWD at 18 months from time of selexipag initiation. Newly initiated patients had a higher rate of discontinuation because of adverse events compared with previously initiated patients (34% vs 16%, respectively).
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
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Kim N, Hemnes A, Chakinala M, et al. Long-term clinical course of the first 250 patients treated with selexipag in real-world settings from the SPHERE registry (selexipag: the users drug registry). Presented at: CHEST Annual Meeting 2019; October 19-23, 2019; New Orleans, LA. Abstract 866.