Real-World Data of Combination Therapy With Macitentan to Treat PAH

Combination therapy plays a central role in treating pulmonary arterial hypertension (PAH), and 2 abstracts presented at the CHEST annual meeting highlighted real-world treatment patterns.

In the first abstract,¹ the researchers used the combined OPsumit Users (OPUS) Registry and OPsumit Historical Users cohort (OrPHeUS) to assess treatment pattern changes over time to manage PAH, comparing patients who initiated macitentan before the 2015 European Society of Cardiology (ESC)/European Respiratory Society (ERS) guidelines (pre-GL) and after the guidelines (post GL). OPUS is a prospective, multicenter, observational drug registry, and OrPHeUS is a multicenter medical chart review.

Of the 4428 total patients, 2318 (52%) initiated macitetan pre-GL and 2110 (48%) initiated the therapy post GL. Although median age and proportion of patients who were female were similar between the pre- and post-GL groups, patients in the post-GL group were far more likely to have been diagnosed in the previous 6 months (52% vs 39%) and had a much shorter median time from diagnosis (5.2 months vs 12.5 months).

The proportion of patients receiving macitetan as a mono, double, or triple therapy remained largely the same. In the pre-GL group, 41% of patients initiated macitentan as a monotherapy, 45% as double therapy, and 14% as a triple therapy. In the post-GL group, 41% initiated macitentan as a monotherapy, 47% as a double therapy, and 13% as a triple therapy.

“The majority of patients initiating macitentan received combination therapy at baseline and 6 months postbaseline across all years reported,” the authors concluded. “However, these proportions remained relatively constant over time, despite recommendations for increased use of combination therapy in the 2015 ESC/ERS PAH GL.”

In the second abstract, the researchers reviewed the OPUS registry to evaluate patients with PAH receiving triple combination therapy.² They described the demographics, patient characteristics, treatment patterns, outcomes, and safety for patients with PAH receiving triple combination therapy of macitentan plus a phosphodiesterase type 5 inhibitor (PDE5i) and a prostacyclin pathway agent.

A total of 404 patients with PAH in the OPUS registry received triple therapy at any point, with 51 patients (12.6%) receiving triple therapy as initial treatment and 353 patients (87.4%) receiving it as sequential treatment. The median time from diagnosis to initiation of triple therapy was 22.7 months.

Half (49.9%) of the patients received triple therapy for ≥ 2 years and 63.4% received triple therapy for 1 year or more. The majority (76.2%) of patients reported at least 1 adverse event and 45.8% of patients stopped triple therapy because they discontinued at least 1 of the drugs: 39 (9.7%) patients discontinued all 3; 10 (2.5%) discontinued 2; 26 (6.4%) discontinued the PDE5i only; 42 (10.4%) discontinued the prostacyclin pathway agent; and 68 (16.8%) discontinued macitentan.

References

1. Chin K, Channick R, McLaughlin V, et al. Treatment patterns in pulmonary arterial hypertension: changes in clinical practice over time using real-world evidence from the combined OPUS/OrPHeUS data sets. Presented at: CHEST Annual Meeting 2020; October 18-21. https://journal.chestnet.org/article/S0012-3692(20)34063-0/fulltext

2. McConnell J, Chin K, Kim N, et al. Experience with macitentan triple combination therapy in pulmonary arterial hypertension: real-world evidence from the OPUS registry. Presented at: CHEST Annual Meeting 2020; October 18-21. https://linkinghub.elsevier.com/retrieve/pii/S0012369220340812