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

Treating moderate-to-severe endometriosis-associated pain with elagolix reduced employment-related absenteeism and presenteeism.

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Volume 112, Issue 3, Pages 545–551

Authors:

Robin M. Pokrzywinski, Ph.D., Ahmed M. Soliman, Ph.D., Jun Chen, M.S., Michael Snabes, Ph.D., Michael P. Diamond, M.D., Eric Surrey, M.D., Karin S. Coyne, Ph.D.

Abstract:

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).


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Fertility and Sterility

Editorial Office, American Society for Reproductive Medicine

Fertility and Sterility® is an international journal for obstetricians, gynecologists, reproductive endocrinologists, urologists, basic scientists and others who treat and investigate problems of infertility and human reproductive disorders.