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

Patient. 2019 Dec;12(6):651-660. doi: 10.1007/s40271-019-00394-7.

Abstract

Background: Endometriosis profoundly impairs women's workplace and household productivity.

Objective: The aim of this study was to evaluate the impact of elagolix on endometriosis-related workplace and household productivity losses.

Methods: Data 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.

Results: Workplace 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.

Conclusions: Treatment with elagolix improved endometriosis-related workplace and household productivity impairments.

Trial registration: ELARIS EM-I (NCT01620528) and ELARIS EM-II (NCT01931670).

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Clinical Trials, Phase III as Topic*
  • Endometriosis / physiopathology*
  • Family Characteristics*
  • Female
  • Humans
  • Hydrocarbons, Fluorinated / therapeutic use*
  • Middle Aged
  • Pain / drug therapy*
  • Pain / physiopathology*
  • Pyrimidines / therapeutic use*
  • Severity of Illness Index
  • Task Performance and Analysis*
  • Workplace*
  • Young Adult

Substances

  • Hydrocarbons, Fluorinated
  • Pyrimidines
  • elagolix

Associated data

  • ClinicalTrials.gov/NCT01620528
  • ClinicalTrials.gov/NCT01931670