12-Month Results Show Elagolix Reduces Uterine Fibroid-Associated Menstrual Bleeding
AUGUST 22, 2018
Cecilia Pessoa Gingerich
Dawn Carlson, MD, MPHAbbVie announced new results from a 12-month extension of the phase 3 ELARIS UF-EXTEND study of elagolix. The new data show that elagolix taken with low-dose hormone therapy reduced heavy menstrual bleeding in 87.9% of women with uterine fibroids.
"Women with uterine fibroids are in need of additional medical management options that could help address unresolved symptoms," said Dawn Carlson, MD, MPH, vice president, general medicine development. "The results from this extension study provide additional information on the use of elagolix for up to 12 months in the management of heavy menstrual bleeding associated with uterine fibroids."
Women in the extension continued to receive elagolix 300 mg twice daily or elagolix 300 mg twice daily with add-back hormone therapy (estradiol 1.0 mg / norethindrone acetate 0.5 mg). Those who had received placebo were randomized to the treatment groups. A clinical response was defined as menstrual blood loss volume of less than 80 mL and a 50% or greater reduction in menstrual blood loss volume from baseline to their final month.
Results from the extension study are consistent with those from the ELARIS UF-I and ELARIS UF-II phase 3 studies, in which 68.5% and 76.2% of women with uterine fibroids who received elagolix with add-back therapy for 6 months achieved clinical response, respectively.
"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 when the ELARIS UF-I results were announced. "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 safety profile in the 12-month extension was in line with previous results and no new safety signals were reported. The most frequent adverse events, occurring in ≥5% of participants, were hot flush, night sweats, nausea, headache and nasopharyngitis.
Reductions in bone mineral density were observed. The 12-month results showed that women taking elagolix with hormone add-back therapy had less mean percent change from baseline bone mineral density compared to women taking just elagolix.
Elagolix was approved by the US Food and Drug Administration in July 2018 for the treatment of moderate to severe pain related to endometriosis.
AbbVie plans to include the ELARIS UF-EXTEND data as part of a submission for regulatory approval of elagolix for the treatment of uterine fibroids in 2019.