Elagolix Meets Primary Endpoint in ELARIS UF-I Study

Dawn Carlson, MD, MPH

Elagolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist developed by AbbVie, has met its primary endpoint of assessing the reduction in heavy menstrual bleeding compared to placebo, according to results from the ELARIS UF-I study (M12-815).

At month 6, elagolix in combination with low-dose hormone therapy reduced heavy menstrual bleeding in 68.5% of women with uterine fibroids compared to 8.7% with placebo (P <.001), measured by the alkaline hematin method.

"Current non-surgical treatments are limited and women suffering from uterine fibroids need more therapeutic options," Dawn Carlson, MD, MPH, the vice president of general medicine development at AbbVie, said in a statement. "The results from this study represent a significant advancement in the development of elagolix and demonstrate our continued commitment to address [the] serious disease."

The 6-month, phase 3 study is the first of 2 and evaluated the clinical response—defined as menstrual blood loss volume of less than 80 mL during month 6 and a ≥50% reduction in menstrual blood loss volume from baseline. The study also met all ranked secondary endpoints (P <.001) at month 6, according to AbbVie.

The safety profile was considered consistent with the results of phase 2 studies. Hypoestrogenic effects—hot flush and reduction in bone mineral density&mdash;were observed, but the remaining safety data is still being analyzed.

Primary analysis will be from the 6-month results, with the participants receiving the option for post-treatment follow-up or a blinded 6-month extension study.

Uterine fibroids are, according to the National Women’s Health Network, are the most common type of pelvic growth in women, impacting up to 80% of women by age 50. In approximately one-quarter of women, the fibroids are symptomatic and can cause heavy menstrual bleeding, painful periods, vaginal bleeding at times other than menstruation, and anemia.

Last September, elagolix was previously submitted to the US Food and Drug Administration (FDA) as a treatment for the management of endometriosis with associated pain. In October, it was granted priority review designation, and the FDA is expected to make a decision regarding the treatment by Q2 2018.

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