Relugolix combination therapy alleviates multiple uterine fibroid symptoms
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Once-daily treatment with a combination of relugolix, estradiol and norethindrone acetate significantly reduced menstrual bleeding with uterine fibroids, according to two randomized studies published in The New England Journal of Medicine.
The combination therapy also preserved bone mineral density in women and provided relief from other uterine fibroid symptoms. Relugolix is a gonadotropin-releasing hormone-receptor antagonist “that is suitable for daily use” without hypoestrogenic effects, researchers said.
Ayman Al-Hendy, MD, a professor of obstetrics and gynecology at the University of Chicago Medicine, and colleagues enrolled premenopausal women from Africa, Europe, North America and South America in the phase-3 LIBERTY 1 (n = 388) and LIBERTY 2 (n = 382) trials. All the women had fibroid-associated heavy menstrual bleeding, were in their 30s and 40s and had BMIs that ranged from the mid-20s kg/m2 to just under 40 kg/m2.
The women were randomly assigned in a 1:1:1 ratio to receive 12 weeks of once-daily treatment with placebo; a combination of 40 mg of relugolix, 1 mg of estradiol and 0.5 mg of norethindrone acetate; or 40 mg of relugolix monotherapy followed by an additional 12 weeks of relugolix combination therapy.
Al-Hendy and colleagues found that 73% of the participants in the relugolix combination therapy group in LIBERTY 1 and 71% of those who received the combination therapy in LIBERTY 2 reached the trials’ primary endpoint: a loss of less than 80 mL in menstrual blood volume and a 50% or greater reduction in menstrual blood volume from baseline. Among the placebo groups, 19% and 15%, respectively, reached those endpoints (P < .001 for both comparisons). According to the researchers, patients who received relugolix combination therapy in both trials experienced significant improvements in six of seven secondary endpoints — volume of menstrual blood loss (including amenorrhea), pain, distress from bleeding and pelvic discomfort, anemia, and uterine volume but not fibroid volume — compared with the placebo groups.
In addition, the incidence of adverse events was similar with relugolix combination therapy and placebo. Hot flash was the most frequently reported adverse event in both trials. Bone mineral density was similar between the relugolix combination therapy and placebo groups. “As expected,” bone mineral density decreased with relugolix monotherapy, but those changes plateaued following the initiation of combination therapy, researchers said.
“With an estimated $34 billion in health care costs associated with fibroids in the United States alone, there is a major need for a nonsurgical long-term treatment option, particularly one that addresses women’s usual preference for uterine-sparing alternatives regardless of their reproductive plans,” Al-Hendy and colleagues wrote.
According to a press release from Myovant Sciences, the FDA accepted a new drug application for the once-daily relugolix combination treatment, and an action date has been set for June 1.
Reference:
Myovant Sciences. Myovant Sciences announces FDA acceptance of new drug application for once-daily relugolix combination tablet for uterine fibroids. https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-announces-fda-acceptance-new-drug-application. Accessed February 15, 2021.
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The mainstay of uterine fibroid treatment historically has been myomectomy or a hysterectomy. There are other options, including uterine artery embolization, but that procedure only works best in women who have smaller fibroids and hormonal therapy. But with this latter option, once you stop, the effects tend to reverse themselves.
Now we have a pill, relugolix. This study by Al-Hendy and colleagues answers some really good questions about this drug: Is this pill going to make women bleed less? Is it going to make them have less pain? And what about significant side effects? Are we going to have problems taking this that are worse than if they took a placebo? It is wonderful to see that relugolix positively answers all three. I would absolutely recommend relugolix to a patient if the FDA approves it because surgery hurts, it is inconvenient, it is expensive and it takes time out of a patient’s life. Even when we do the newer procedures, patients still generally spend a night in the hospital, and they are sore for a few days.
There could be concerns about the price. Physicians whose patients do not have insurance or limited insurance have a tough call to make when deciding if a pill or surgery would be best to treat the patient’s uterine fibroids. Not every physician is created equal. And for these types of surgeries, it requires a lot of experience and training that many physicians do not have.
Professor, Oakland University William Beaumont School of Medicine
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