AbbVie has announced new results from a 12-month extension of the ELARIS UF EXTEND Phase III trial of elagolix. The new data show that Elagolix with low-dose hormone therapy reduces severe menstrual bleeding in 87.9% of women with uterine fibroids.
"Women with uterine fibroids need additional medical treatment options that can help treat unresolved symptoms." said Dawn Carlson, MD, MPH, vice president, general medicine development. "The results of this extension study provide additional information on the use of Elastolix for up to 1
Women in the extension continued to receive 300 mg twice daily or Elagolix 300 mg twice daily with additional hormone therapy (estradiol 1.0 mg / norethindrone acetate 0.5 mg). Those who received placebo were randomized to treatment groups. Clinical response was defined as a menstrual blood loss volume of less than 80 ml and a reduction in the volume of menstrual blood loss by 50% or more from baseline to last month.
The results of the extension study are consistent with those of the ELARIS UF -I and ELARIS UF-II phase III trials, in which 68.5% and 76.2% of women with uterine fibroids who have been receiving adjunctive therapy for 6 months Elagolix achieved a clinical response.
"Current non-surgical treatments are women who suffer from uterine fibroids need more therapeutic options," said Dawn Carlson, MD, MPH, vice president of general medical development at AbbVie, when the results of ELARIS UF-I were announced. "The results of this study represent a significant advance in the development of elagolix and demonstrate our ongoing commitment to treating [the] serious illnesses."
The safety profile in the 12-month extension corresponded to earlier results and was not new safety signals were reported. The most common adverse events that occurred in ≥5% of participants were hot flushes, night sweats, nausea, headache, and nasopharyngitis.
A reduction in bone mineral density was observed. The 12-month results showed that women taking Elastolix with hormone add-back therapy had a lower percentage change from baseline bone mineral density than women taking elastolix alone.
Elagolix was approved by the US Food and Drug Administration in July 2018 for the treatment of moderate to severe pain associated with endometriosis
AbbVie plans to release the data from ELARIS UF-EXTEND as part of a marketing authorization Elagolix for the treatment of uterine fibroids 2019.