Elagolix (Orilissa) significantly reduced heavy menstrual bleeding in women with uterine fibroids, according to the results of two phase III clinical trials.
More women that took elagolix with “add-back” therapy (like a birth control pill) experienced significant reductions in heavy menstrual bleeding compared to women that received placebo, reported William Schlaff, MD, of Thomas Jefferson University in Philadelphia, and colleagues.
Hypoestrogenic effects of the drug, especially bone density loss, were reduced when elagolix was taken with add-back therapy, researchers wrote in the New England Journal of Medicine.
Researchers first presented the results of two randomized trials of elagolix at the American College of Obstetricians and Gynecologists (ACOG) annual meeting in May 2019. They found that 68.5% to 76.5% of women randomized to elagolix with add-back therapy were associated with reductions in heavy menstrual bleeding compared to 8.7% to 10% of women in the placebo group.
Hot flushes and metrorrhagia, or abnormal uterine bleeding, were more common among women who took elagolix plus add-back therapy compared to women in the placebo group. Schlaff and colleagues noted that more than 60% of women in each trial reported an adverse event, but the majority of adverse events were not considered serious.
Elagolix, previously approved to treat endometriosis pain, provides women with an alternative therapy for fibroid-related bleeding, as opposed to current treatments such as oral contraceptives, injectable gonadotropin-releasing hormone receptor (GnRH) agonists, hysterectomy, or other less-invasive surgical interventions.
Most experts contacted by MedPage Today thought that while elagolix was another option to treat uterine fibroids, it would be better for certain groups of patients than others.
“It’s really promising and helpful to give another option for treatment,” said Lauren Schiff, MD, of the University of North Carolina in Chapel Hill, who was not involved with the research.
But she added that elagolix is “limited within its scope,” saying that she thought it could only be used short-term due to bone density concerns.
Schiff suggested that elagolix might be used in younger patients as a bridge to surgery, or in patients close to menopause. But she did not think this treatment changed long-term options for patients with uterine fibroids.
“It’s not going to be the end treatment for women in the midst of their reproductive years,” Schiff told MedPage Today.
Jacques Moritz, MD, of the Tia Center, a women’s health center in New York City, said that as a treatment for heavy bleeding associated with fibroids, elagolix is evolutionary, but not revolutionary.
“This is a treatment for fibroids, it’s not a cure for fibroids,” Moritz said in an interview with MedPage Today. He added that this drug could be an option to prevent a woman from needing surgery until she naturally hits menopause.
Louise King, MD, of Beth Israel Deaconess Medical Center in Boston, who was also not involved with the research, said that the more treatment options out there for women with fibroids, the better.
“But once it’s an option, you have to help women with shared-decision making,” King told MedPage Today in an interview. She added that physicians should help patients understand how the side effects of earlier menopause — many of which are common with elagolix — might impact their quality of life.
Moritz said that further research might assess how elagolix impacts fibroid shrinkage, and he was interested in whether or not the drug might be useful at the time of surgery. He said that the impact elagolix may have on blood loss during surgery or length of procedures might be an area for further research.
When commenting on next steps for research, Schiff added that it was important to find the right niche for this drug.
“It doesn’t solve all fibroid problems. But it definitely has a role that will help patients achieve their goals,” she said.
Schlaff disclosed support from AbbVie and Antares Pharma.
Co-authors disclosed support from Allergan, Amgen, Actavis, Bayer, MD Stem Cells, Myovant, AbbVie, and ObsEva.