• Fertility and sterility · Sep 2019

    Randomized Controlled Trial Multicenter Study

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

    • Robin M Pokrzywinski, Ahmed M Soliman, Jun Chen, Michael Snabes, Michael P Diamond, Eric Surrey, and Karin S Coyne.
    • Evidera, Bethesda, Maryland. Electronic address: robin.pokrzywinski@evidera.com.
    • Fertil. Steril. 2019 Sep 1; 112 (3): 545-551.

    ObjectiveTo estimate the impact of elagolix on work loss due to endometriosis-associated pain.DesignPost hoc analysis of data from the Elaris I and II clinical trials.SettingNot 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).Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.

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