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Health-Related Quality of Life With Ulipristal Acetate for Treatment of Uterine Leiomyomas

A Randomized Controlled Trial

Lukes, Andrea S., MD; Soper, David, MD; Harrington, Amanda, PhD; Sniukiene, Vilma, MD; Mo, Yifan, PhD; Gillard, Patrick, PharmD, MS; Shulman, Lee, MD

doi: 10.1097/AOG.0000000000003211
Leiomyomas: Original Research: PDF Only
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PAP

OBJECTIVE: To investigate effects of ulipristal acetate on health-related quality of life (QOL) and symptom severity in women with symptomatic uterine leiomyomas and abnormal uterine bleeding.

METHODS: Women were randomized to ulipristal (5 mg, 10 mg) or placebo in two phase 3, multicenter, double-blind, placebo-controlled trials (VENUS I and II). Health-related QOL and symptom severity were assessed at baseline, and over one (VENUS I and II) and two (VENUS II) 12-week treatment courses using the Uterine Fibroid Symptom Health-Related Quality of Life questionnaire. In pooled VENUS I and II data, change from baseline to the end of the first course for each Uterine Fibroid Symptom Health-Related Quality of Life scale was analyzed, including a Revised Activities subscale that measured physical and social activities. The proportion of women achieving meaningful change in the Symptom Severity (20 or more points), Health-Related QOL Total (20 or more points), and Revised Activities (30 or more points) scales was calculated. In VENUS II data, change from baseline to the end of each course in each scale was analyzed for each treatment arm.

RESULTS: In pooled analyses, the intent-to-treat population included 589 patients (placebo, n=169; ulipristal 5 mg, n=215; ulipristal 10 mg, n=205). Significantly greater improvements from baseline in all Uterine Fibroid Symptom Health-Related Quality of Life scales were observed with both ulipristal doses compared with placebo (P<.001). A meaningful change in Revised Activities was achieved by 51 patients receiving placebo (34.9%), compared with 144 (73.5%; OR 5.0 [97.5% CI 2.9–8.6]) and 141 (80.6%; OR 7.9 [97.5% CI 4.3–14.6]) patients receiving ulipristal 5 mg, and 10 mg, respectively. In VENUS II, at end of courses 1 and 2, both ulipristal doses demonstrated significant improvements from baseline compared with placebo for all Uterine Fibroid Symptom Health-Related Quality of Life scales (P<.01). Mean Revised Activities scores showed that beneficial ulipristal effects were maintained in course 2, and improvements occurred on switching to ulipristal; results for other scales were similar.

CONCLUSION: Ulipristal was associated with significant improvements in health-related QOL and symptom severity compared with placebo for women with symptomatic uterine leiomyomas.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02147197 and NCT02147158.

FUNDING SOURCE: Allergan plc, Dublin, Ireland.

This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Ulipristal acetate is associated with significant improvements in health-related quality of life and symptom severity compared with placebo in women with symptomatic uterine leiomyomas.

Carolina Women's Research and Wellness Center, Durham, North Carolina; Medical University of South Carolina, Charleston, South Carolina; Allergan plc, Irvine, California; Allergan plc, Madison, New Jersey; and the Feinberg School of Medicine, Northwestern University, Chicago, Illinois.

Corresponding author: Andrea S. Lukes, MD, Carolina Women's Research and Wellness Center, 249 E NC Highway 54, Suite 330, Durham, NC 27713; email: andrealukes@cwrwc.com.

Sponsored by Allergan plc, Dublin, Ireland. Writing and editorial assistance was provided to the authors by Kevin De-Voy, MSc, on behalf of Complete HealthVizion, and by Laura Gibbons, PhD, of Complete HealthVizion, and funded by Allergan plc, Dublin, Ireland. All authors met the ICMJE authorship criteria. Neither honoraria nor payments were made for authorship.

Financial Disclosure Dr. Lukes has been involved in consulting and advisory boards for the following entities: AbbVie, Myovant, Allergan plc; and has received research grants from Allergan, AbbVie, Merck, Bayer, GlaxoSmithKline, Ferring, Inovio, Sequoia, and Myovant. Dr. Soper has received grants from Allergan, AbbVie, and Bayer. Drs. Harrington, Sniukiene, Mo, and Gillard are employees of Allergan plc. Dr. Shulman has been involved in speaking, advising, consulting, and educational programs for the following entities: AHM LLC, AMAG Pharmaceuticals; Bayer AG; Celula Inc.; Connect Healthcare Inc.; Cory Paeth LLC, Counsyl; Allergan plc; Grey Healthcare Group; Health Advances LLC; Interpublic Group; IntraMed; Meeting Logistics LLC; Merck & Co. Inc.; Natera Inc.; NeoSeq; PharmaWrite LLC; Previvo Genetics LLC; Progenity Inc.; Qiagen; Roche Diagnostics Corporation; Sera Prognostics; and Vermillion.

Presented in part at the American Society for Reproductive Medicine's Annual Meeting, October 6–10, 2018, Denver, Colorado.

Each author has confirmed compliance with the journal's requirements for authorship.

Peer reviews and author correspondence are available at http://links.lww.com/AOG/B327.

Received October 03, 2018

Received in revised form December 20, 2018

Accepted January 10, 2019

© 2019 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.