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Elagolix with add-back therapy appears efficacious despite uterine and fibroid factors

Key clinical point: Uterine fibroid volume, fibroid stage, and uterine volume do not appear to affect the efficacy of elagolix in patients with heavy menstrual bleeding from fibroids.

Major finding: Patients receiving elagolix plus add-back therapy responded to treatment better than placebo, and there were no significant differences in outcomes in terms of FIGO stage. Response was as follows for patients with FIGO 0-3 classified fibroids (78% of 47 patients vs. 9% of 25 patients), FIGO 4 fibroids (68% of 177 patients vs. 15% of 85 patients) and FIGO 5-8 fibroids (74% of 165 patients vs. 4% of 82 patients).

Study details: A subgroup analysis of 790 patients with heavy menstrual bleeding who received elagolix alone, elagolix with add-back therapy, or placebo for 6 months in the Elaris UF-1 and UF-2 trials.

Disclosures: This study was funded by AbbVie, and the company was involved in the study design, research, data collection, analysis, and interpretation of the data, as well as the writing, reviewing, and approving of the study for publication. The authors reported various relationships with industry, pharmaceutical companies, government entities, and other organizations.

Citation:

Al-Hendy A et al. ASRM 2019, Abstract O-205.