Uterine fibroids: Nonresponders to elagolix+add-back therapy may still have a clinically meaningful response

Key clinical point: Nearly half the patients with uterine fibroids (UF) considered nonresponders to elagolix plus add-back therapy in the 2 phase 3 trials showed a clinically meaningful reduction in menstrual blood loss (MBL).

Major finding: Overall, 24% of patients treated with elagolix+add-back therapy were considered nonresponders as they did not meet 1 or more criteria among MBL less than 80 mL, 50% or more reduction in MBL, and/or premature treatment discontinuation. Of these, 19% met both the bleeding criterion but discontinued treatment and 26% met 1 bleeding criterion. At month 1, the least mean percent change in MBL in nonresponders who met both bleeding criteria was 80.3%.

Study details: Findings are from a pooled post hoc analysis of phase 3 Elaris UF-1 and UF-2 trials, including 549 premenopausal women with UF and heavy menstrual bleeding who received elagolix+add-back therapy or placebo.

Disclosures: This study was funded by AbbVie. Some investigators reported ties with various sources including Abbvie. Three authors declared being current/former employees and/or shareholders of AbbVie.

Source: Stewart EA et al. J Womens Health. 2021 Sep 28. doi: 10.1089/jwh.2021.0152.

Key clinical point: Nearly half the patients with uterine fibroids (UF) considered nonresponders to elagolix plus add-back therapy in the 2 phase 3 trials showed a clinically meaningful reduction in menstrual blood loss (MBL).

Major finding: Overall, 24% of patients treated with elagolix+add-back therapy were considered nonresponders as they did not meet 1 or more criteria among MBL less than 80 mL, 50% or more reduction in MBL, and/or premature treatment discontinuation. Of these, 19% met both the bleeding criterion but discontinued treatment and 26% met 1 bleeding criterion. At month 1, the least mean percent change in MBL in nonresponders who met both bleeding criteria was 80.3%.

Study details: Findings are from a pooled post hoc analysis of phase 3 Elaris UF-1 and UF-2 trials, including 549 premenopausal women with UF and heavy menstrual bleeding who received elagolix+add-back therapy or placebo.

Disclosures: This study was funded by AbbVie. Some investigators reported ties with various sources including Abbvie. Three authors declared being current/former employees and/or shareholders of AbbVie.

Source: Stewart EA et al. J Womens Health. 2021 Sep 28. doi: 10.1089/jwh.2021.0152.

Key clinical point: Nearly half the patients with uterine fibroids (UF) considered nonresponders to elagolix plus add-back therapy in the 2 phase 3 trials showed a clinically meaningful reduction in menstrual blood loss (MBL).

Major finding: Overall, 24% of patients treated with elagolix+add-back therapy were considered nonresponders as they did not meet 1 or more criteria among MBL less than 80 mL, 50% or more reduction in MBL, and/or premature treatment discontinuation. Of these, 19% met both the bleeding criterion but discontinued treatment and 26% met 1 bleeding criterion. At month 1, the least mean percent change in MBL in nonresponders who met both bleeding criteria was 80.3%.

Study details: Findings are from a pooled post hoc analysis of phase 3 Elaris UF-1 and UF-2 trials, including 549 premenopausal women with UF and heavy menstrual bleeding who received elagolix+add-back therapy or placebo.

Disclosures: This study was funded by AbbVie. Some investigators reported ties with various sources including Abbvie. Three authors declared being current/former employees and/or shareholders of AbbVie.

Source: Stewart EA et al. J Womens Health. 2021 Sep 28. doi: 10.1089/jwh.2021.0152.