Improvement in health-related quality of life (HRQoL) in women with uterine fibroids (Uf) treated with vilaprisan (VPR): a summary of results from asteroid 1 and 2

Abstract

To assess the impact of VPR, ulipristal acetate (UPA) and placebo on HRQoL in women with UFs. Two multicenter, double-blind, randomized phase 2 studies examining the efficacy and safety of VPR compared with placebo (ASTEROID 1 and 2), and an active comparator (ASTEROID 2). 309 and 172 women with UFs and heavy menstrual bleeding (HMB) were enrolled in ASTEROID 1 and 2, respectively. In ASTEROID 1, women received oral placebo or VPR 0.5 mg, 1 mg, 2 mg, or 4 mg once daily (OD) for 12 weeks, with follow-up at 24 weeks. In ASTEROID 2, women received VPR 2 mg, UPA 5 mg, or placebo OD for one or two 12-week treatment periods, with 12 weeks’ follow-up. HRQoL was assessed using the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) questionnaire and the Short-Form 36 Health Survey Version 2 (SF-36v2) during baseline (BL), end of treatment (EoT) and end of follow-up (EoFUP) visits. Across treatment groups in ASTEROID 1 at BL, the mean (SD) UFS-QoL total HRQoL scores were between 46.2 (24.1) and 49.9 (25.0)SF-36v2 physical component scores (PCS) were between 45.6 (7.3) and 47.5 (7.8), and SF-36v2 mental component scores (MCS) were between 43.3 (11.5) and 47.5 (8.3). All BL scores were in line with previously published data for women with UFs.1 At EoT, the mean total and subscale UFS-QoL and SF-36v2 scores in all VPR-treated groups increased compared with BL. These increases were greater than those observed with placebo. The mean (SD) UFS-QoL total HRQoL scores increased to 83.2 (19.7) in the highest and 78.3 (24.0) in the lowest VPR dose group, versus 56.2 (24.8) in the placebo group. Mean (SD) SF-36v2 PCS and MCS increased to 51.7 (6.2) and 52.0 (8.9) in the lowest VPR dose group, and 53.7 (6.5) and 51.1 (8.9) in the highest VPR dose group, respectively. By comparison, the mean (SD) PCS and MCS at EoT in the placebo group were 48.4 (7.8) and 43.9 (12.2), respectively. The EoT UFS-QoL and SF-36v2 scores of women that received VPR were in the range of those previously published for healthy women without UFs1. Similar results were observed in ASTEROID 2. Mean UFS-QoL HRQoL and SF-36v2 BL scores increased continuously during treatment with VPR for up to 24 weeks, whereas increased scores were observed for the first 12 weeks with UPA but did not continue to 24 weeks (not statistically tested). The mean (SD) UFS-QoL total HRQoL scores across VPR dosage groups increased from between 78.5 (21.0) and 81.9 (16.4) after 12 weeks, to between 82.4 (17.5) and 85.6 (13.2) after 24 weeks’ treatment. In the UPA group, this score decreased from 75.0 (19.6) at 12 weeks to 73.4 (20.8) at 24 weeks. In general, the mean UFS-QoL total HRQoL and SF-36v2 scores decreased only slightly between treatment cessation and EoFUP across active treatment groups in ASTEROID 1 (6 months) and 2 (3 months). In ASTEROID 1 and 2, increases in mean UFS-QoL and SF-36v2 HRQoL scores were observed alongside reduced HMB in women with UFs during active treatment with VPR and UPA for up to 24 weeks, and were sustained to EoFUP. Furthermore, by EoT, HRQoL scores increased to levels previously published for healthy women without UFs.1