Impact of Elagolix on Workplace and Household Productivity Among Women with Moderate to Severe Pain Associated with Endometriosis: A Pooled Analysis of Two Phase III Trials

Abstract

BackgroundEndometriosis profoundly impairs women’s workplace and household productivity.ObjectiveThe aim of this study was to evaluate the impact of elagolix on endometriosis-related workplace and household productivity losses.MethodsData were pooled from two phase III trials of women aged 18–49 years with moderate to severe endometriosis-associated pain treated for 6 months with elagolix 150 mg daily (QD), 200 mg twice daily (BID), or placebo. The Health-Related Productivity Questionnaire was administered at baseline, Month 3, and Month 6 to determine workplace and household absenteeism and presenteeism. Productivity changes from baseline were compared between placebo and elagolix doses via analysis of covariance.ResultsWorkplace analyses included 1270 employed women and household analyses included 1565 women. At baseline, women reported average weekly losses of 16 workplace hours, 8.3 household work hours, 45% of scheduled work, and 64% of planned household chores. At Month 6, treatment with elagolix 150 mg QD or 200 mg BID increased productive workplace hours by 1.7 (95% CI 0.1–3.4; p = 0.041) and 5.4 h (95% CI 3.7–7.1; p < 0.001) relative to placebo, corresponding to gains of 5.2% (95% CI 0.7–9.7; p = 0.022) and 14.6% (95% CI 10.0–19.1; p < 0.001) of scheduled work, respectively. Both elagolix doses improved household productivity at Month 6 by 1.7 (95% CI 0.7–2.7) and 3.1 (95% CI 2.1–4.0) hours relative to placebo (both p < 0.001), with increases of 8.8% (95% CI 3.5–14.1; p = 0.001) and 20.4% (95% CI 15.1–25.6; p < 0.001) of planned household work.ConclusionsTreatment with elagolix improved endometriosis-related workplace and household productivity impairments.Trial RegistrationELARIS EM-I (NCT01620528) and ELARIS EM-II (NCT01931670)

A Clinician's Guide to the Treatment of Endometriosis with Elagolix

“…Although there are dissenting views, 28 recent studies support the use of this new, orally active modality. [29][30][31][32][33] The aim of this review is to provide a practical guide for use of elagolix based on available evidence and clinical experience. It is anticipated that with ongoing experience, expertise will continue to develop regarding the best use of pharmaceutical agents for the management of endometriosis symptomatology.…”

Elagolix in the treatment of endometriosis: impact beyond pain symptoms

“… 43 The changes from baseline over 6 months in workplace and household productivity are illustrated in Figures 3 and 4 , respectively. 42 Both doses of elagolix were associated with significant improvements in productive workplace hours, but the effect was greatest for the 200 mg twice daily group. Relative to placebo, women treated with elagolix 150 mg/day gained 2.4 productive workplace hours per week at 3 months ( p = 0.002) and 1.7 workplace hours per week at 6 months ( p = 0.041).…”

“…Workplace and household productivity in the populations of the EM-I and EM-II trials were assessed in a post hoc analysis. 41,42 The analysis of workplace productivity included 1270 women who were employed full-or part-time, while the household analysis included 1565…”

“…Workplace and household productivity in the populations of the EM-I and EM-II trials were assessed in a post hoc analysis. 41 , 42 The analysis of workplace productivity included 1270 women who were employed full- or part-time, while the household analysis included 1565 women. Productivity was assessed using the Health-Related Productivity Questionnaire, a nine-item instrument that assesses the ability to perform employment- and household-related activities.…”

“…Mean hours gained in household productivity, defined as −1 × LS mean change from baseline in hours of household productivity lost due to absenteeism, presenteeism and total hours lost (absenteeism + presenteeism). p < 0.05 (*), p < 0.01 (**), p < 0.001 (***).Source: With kind permission from Springer Science + Business Media: Surrey and colleagues,42 Copyright © 2019, Springer Nature. BID, twice daily; CI, confidence interval; EM-I, Elaris Endometriosis I; EM-II, Elaris Endometriosis II; LS, least squares; PBO, placebo; QD, once daily.…”