Pulmonary arterial hypertension (PAH) leads to reduced health-related quality of life (HRQoL). The objectives of this analysis were to evaluate the effect of macitentan on HRQoL in PAH patients in the SERAPHIN study. The association between baseline HRQoL and long-term outcomes was also investigated.
Patients were randomized to placebo, macitentan 3 mg or macitentan 10 mg once daily. Patients aged ≥14 years completed the SF-36 questionnaire at baseline, Month 6, Month 12 and end of treatment (EOT). The absolute change from baseline to Month 6 in SF-36 scores was calculated. The time to a clinically meaningful deterioration in SF-36 physical and mental component summary (PCS and MCS) scores and associations between baseline PCS/MCS scores and time to morbidity/mortality event were also assessed.
At Month 6, macitentan 10 mg significantly improved 7 of 8 SF-36 domains, and the PCS and MCS scores, versus placebo. Macitentan 10 mg significantly reduced the risk of a ≥3-point deterioration in PCS (HR 0.60, 95% CL 0.47-0.76, P<0.0001) and MCS scores (HR 0.76, 95% CL 0.61-0.95, P=0.0173) up to EOT versus placebo. Patients with a baseline PCS score above the median baseline value had a significantly reduced risk of morbidity/mortality compared with patients with a PCS score below the median; a similar result was observed for the MCS score.
Macitentan significantly improved HRQoL in PAH patients compared with placebo and significantly reduced the risk of a clinically meaningful HRQoL deterioration. An association between better baseline HRQoL and improved long-term outcomes was shown.