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

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).

• Authors: Eric S Surrey, Ahmed M Soliman, Hannah L Palac, Sanjay K Agarwal
• Journal: The patient (Patient) Vol. 12 Issue 6 Pg. 651-660 (12 2019) ISSN: 1178-1661 [Electronic] New Zealand
• PMID: 31654294 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Hydrocarbons, Fluorinated
• Pyrimidines
• elagolix

Topics

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