15 February 2020 by Janis Pruett

Maintenance Dose reached and Discontinuation of Selexipag in Patients treated for Pulmonary Arterial Hypertension (PAH)

Rationale

Selexipag is a prostacyclin receptor agonist approved by the US Food and Drug Administration (FDA) (December 2015) for the treatment of PAH.  As described in GRIPHON (pivotal long-term RCT for Selexipag), the package insert describes bid administration with a usual starting dose of 200 ug to individualized maximum tolerated dose (MTD) up to 1600 ug BID.  Selexipag is known to be efficacious at any individual maintenance dosein mono- and combination therapy. Currently, there is limited data available documenting real-world utilization of selexipag in the treatment of PAH. 

Methods

This observational, retrospective, baseline study used deidentified data (study period 01JAN2016-29MAR2019) from the specialty pharmacies dispensing selexipag to document duration of titration, maintenance dose, and persistence.  The maintenance dose was determined as reached when the dose shipped was consistent (with BID dosing) for a 30--day supply.

Results

A total of 6,709 patients had ≥1 selexipag prescriptions during the study period and 641 (9.6%) failed to meet the inclusion criteria.  A total of 3,931 patients (58.6%) reached a maintenance dose. Most (2,058; 52.4%) attained a high dose (≥ 1200-1600 µg BID); the most frequent dose was 1600 µg BID (39.5%). The mean duration of titration was 14 weeks (97.7 days (64.2)) and 68.2% were persistent at 6-months. However, 2,137 (31.9%) patients did not reach a maintenance dose during the observation periodandmost (1,517, 22.6%) discontinued.See Table 1 in full pdf for other results.

Conclusion

The maintenance dose for most patients was 1600 µg BID. However, many patients discontinued during titration and prior to reaching maintenance (22.6%).  Recently, efforts are underway to educate patients and providers about the “dose adjustment” process to help patients reach “personalized dosing”.  Further research to assess its impact on dosing, persistence, and discontinuation will be needed. 

Key Contributors

Harold I Palevsky, MD1, Janis Pruett, EdD, FNP-BC2, Lin Xie, MS, MA3, Adesuwa Ogbomo, MBBS, MPH3, Huiqi Wang, MS3, and Rajesh Mallampati, MPH3, Robert Dufour, PhD2 1. University of Pennsylvania, Philadelphia, PA, USA; 2. Actelion Pharmaceuticals US, Inc, South San Francisco, CA, USA; 3. Statinmed, Ann Arbor, MI, USA


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