American College of Obstetrics and Gynecology Annual Clinical and Scientific Meeting

American College of Obstetrics and Gynecology Annual Clinical and Scientific Meeting

Source:

Stewart EA, et al. Relugolix combination therapy reduced uterine fibroid-associated pain in two phase 3 LIBERTY studies. Presented at: American College of Obstetrics and Gynecology Annual Clinical and Scientific Meeting; October 30-31, 2020; Virtual.

Disclosures: Stewart reports serving as a consultant for AbbVie, Bayer, ObsEva and Myovant. She also reports holding a patent for Methods and Compounds for Treatment of Abnormal Uterine Bleeding, as well as receiving royalties from UpToDate and payments for the development of educational content from the Med Learning Group, PER, Peer View and Massachusetts Medical Society.
November 06, 2020
2 min read
Save

Relugolix combination therapy relieves uterine fibroid pain

Source:

Stewart EA, et al. Relugolix combination therapy reduced uterine fibroid-associated pain in two phase 3 LIBERTY studies. Presented at: American College of Obstetrics and Gynecology Annual Clinical and Scientific Meeting; October 30-31, 2020; Virtual.

Disclosures: Stewart reports serving as a consultant for AbbVie, Bayer, ObsEva and Myovant. She also reports holding a patent for Methods and Compounds for Treatment of Abnormal Uterine Bleeding, as well as receiving royalties from UpToDate and payments for the development of educational content from the Med Learning Group, PER, Peer View and Massachusetts Medical Society.
You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

New findings from the phase 3 LIBERTY trials showed that relugolix combination therapy significantly improved pain associated with uterine fibroids compared with placebo.

The data were presented during the virtual American College of Obstetrics and Gynecology Annual Clinical and Scientific Meeting.

Stewart on relugolix for uterine fibroids

Relugolix combination therapy (CT; Myovant Sciences) is an oral gonadotropin-releasing hormone (GnRH) antagonist that can be administered once daily for the treatment of uterine fibroids, according to Elizabeth A. Stewart, MD, gynecologist and reproductive endocrinologist at the Mayo Clinic in Rochester, Minnesota.

“The first drug in this class received FDA approval earlier this year but requires twice-daily dosing and did not present data on pain relief,” she told Healio Primary Care.

Relugolix CT is comprised of 40 mg of relugolix, 1 mg of estradiol and 0.5 mg of norethindrone acetate. Previous data from the replicate, double-blind, randomized, placebo-controlled LIBERTY trials showed that it significantly improved heavy menstrual bleeding in women with uterine fibroids. The current analysis evaluated its effect on pain, “a common and unrecognized problem related to uterine fibroids,” Stewart said.

After 24 weeks of treatment, Stewart and colleagues compared the prevalence of women with no-to-minimal uterine fibroid-associated pain in the last 35 days. In the LIBERTY 1 trial, 43.1% of the 58 women who received relugolix CT reported no-to-minimal pain compared with 10.1% of the 69 women who received placebo, according to the researchers. In the LIBERTY 2 trial, 47.1% of the 68 women who received relugolix vs. 17.1% of the 82 women who received placebo reported no-to-minimal pain.

The observed benefit of relugolix CT was more pronounced for menstrual vs. nonmenstrual pain, according to the researchers. On menstrual days, the proportion of women with no-to-minimal pain over the last 35 days of treatment in the LIBERTY 1 and LIBERTY 2 trials was 63.6% and 66.1% among those who received relugolix CT vs. 13.2% and 24.7% among those who received placebo, respectively. On nonmenstrual days, the proportion of women with no-to-minimal pain in LIBERTY 1 and LIBERTY 2 was 40% and 50% in the relugolix CT group vs. 17.7% and 25% in the placebo group.

“In combination with previously reported data for relugolix CT on reduction in heavy menstrual bleeding with preservation of bone density, these results are very promising since they demonstrate improvement in two big categories of fibroid symptoms,” Stewart said.

The researchers also noted that relugolix CT was well-tolerated among participants.