Impact of elagolix on work loss due to endometriosis-associated pain: estimates based on the results of two phase III clinical trials.

Objective: To estimate the impact of elagolix on work loss due to endometriosis-associated pain.

Design: Post hoc analysis of data from the Elaris I and II clinical trials.

Setting: Not applicable.

Patient(s): Employed women ages 18-49 years with moderate-to-severe endometriosis-associated pain.

Intervention(s): In the two trials, participants were randomized to 6 months of treatment with placebo, elagolix 150 mg once a day, or elagolix 200 mg twice a day.

Main Outcome Measure(s): Data on planned work hours, presenteeism, absenteeism, and total work loss (absenteeism + presenteeism) at baseline and month 3 were collected using the Health-Related Productivity Questionnaire.

Result(s): This analysis included employed participants from EM-I (n = 672) and EM-II (n = 626). Between baseline and month 3, compared with participants treated with placebo, participants treated with elagolix 150 mg once a day gained > 2 hours total work/week (EM-I, 2.20 ± 1.03; EM-II, 2.65 ± 1.14). Participants treated with 200 mg twice a day gained > 4 hours total work/week (EM-I, 4.91 ± 1.04; EM-II, 4.64 ± 1.14). Both absenteeism and presenteeism were reduced, although most of the gain was due to reduced presenteeism. Estimated cost savings after 6 months of treatment with elagolix were > $1,500 U.S. at 150 mg once a day and > $3,300 U.S. at 200 mg twice a day.

Conclusion(s): Compared with placebo, treating moderate-to-severe endometriosis-associated pain with elagolix reduced absenteeism and improved productivity in employed women, which should result in cost savings.

Clinical Trial Number(s): NCT01620528 (EM-I) and NCT01931670 (EM-II).