Multiple disease progression events less likely with continued inhaled treprostinil
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In a post hoc analysis of the INCREASE study, patients with interstitial lung disease-associated pulmonary hypertension who continued inhaled treprostinil were less likely to experience further disease progression events vs. placebo.
Steven D. Nathan, MD, director of the advanced lung disease program and the lung transplant program at Inova Fairfax Hospital in Falls Church, Virginia, and colleagues conducted a post hoc analysis of 326 patients with pulmonary hypertension-associated ILD enrolled in the INCREASE study.
The analysis, presented at the American Thoracic Society International Conference, evaluated continued treatment with inhaled treprostinil (Tyvaso, United Therapeutics) on multiple disease progression events. Patients had at least one disease progression event, which was defined as a 15% or greater decline in 6-minute walk distance, exacerbation of underlying lung disease, cardiopulmonary hospitalization, lung transplantation or death.
Healio previously reported the main results of the INCREASE study. Patients were randomly assigned to receive inhaled treprostinil (n = 163; mean age, 65.6 years) at 6 µg per breath or placebo (n = 163; mean age, 67.4 years) four times per day.
Over 16 weeks of follow-up, there were 150 disease progression events that occurred in 79 patients (48%) assigned inhaled treprostinil and 226 events that occurred in 95 patients (58%) assigned placebo, according to the results.
Researchers observed fewer multiple clinical worsening events in the inhaled treprostinil group compared with placebo (21% vs. 39%; P < .001). Most of the subsequent events were decline in 6-minute walk distance or exacerbation of underlying lung disease, Nathan said during the presentation. There were 10 deaths (6.1%) in the treprostinil group compared with 12 (7.4%) in the placebo group, he said.
In addition, the researchers reported that inhaled treprostinil was associated with a delay in time to both the first clinical worsening event (HR = 0.75; 95% CI, 0.56-1.01; P = .061) and the second event (HR = 0.59; 95% CI, 0.39-0.9; P = .014).
Nathan noted several limitations of the analysis, including its short duration and premature discontinuation before week 16 in 21% of patients.
“In conclusion, I think this is very helpful for clinicians in the field. For those patients who are on inhaled treprostinil, if they do have clinical worsening, they should continue on inhaled treprostinil,” Nathan said. “It does not mean that the drug is not working, because they’re going to have continued benefit with regard to subsequent clinical worsening events including mortality.”