Elagolix in the treatment of endometriosis: impact beyond pain symptoms

Abstract

While the most common symptom associated with endometriosis is pelvic pain, the systemic manifestations of the disease and the accompanying adverse psychological, emotional, social, familial, sexual, educational and workplace effects are increasingly recognized. Elagolix is an oral gonadotropin-releasing hormone receptor antagonist that is approved for the management of moderate to severe pain associated with endometriosis. However, the benefits of elagolix extend beyond reducing pain symptoms. This article reviews the non-pain systemic manifestations associated with endometriosis and summarizes the beneficial effects of elagolix on non-pain outcomes. This includes improvements in quality of life, reductions in fatigue and improvements in workplace and household productivity. These results indicate that elagolix provides non-pain benefits in women with endometriosis and improves outcomes that are clinically meaningful to patients.

Keywords: elagolix; endometriosis; fatigue; phamacoeconomics; quality of life.

Figure 1.

Mean change from baseline to month 6 in the EHP-30 scores in patients receiving elagolix 150 mg once daily or 200 mg twice daily or placebo in (a) EM-I and (b) EM-II. Each domain had multiple questions. Each question was scored from 0 (never) to 4 (always) and normalized to a scale of 0–100 for each domain. Lower scores indicate better quality of life. Statistical significance was based on contrasts within a one-way ANCOVA with treatment as the main effect and baseline value as a covariate. The mean difference from placebo is indicated for two-sided p value; p < 0.05 (*), p < 0.01 (**), p < 0.001 (***). Error bars respresent standard error and month 0 refers to baseline. Source: From Taylor and colleagues, Copyright © 2017 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society. ANCOVA, analysis of covariance; BID, twice daily; EHP-30, 30-item Endometriosis Health Profile; LS, least squares; QD, once daily.

Figure 2.

Mean change from baseline to month 6 in the PROMIS Fatigue Questionnaire T-scores in patients receiving elagolix 150 mg once daily or 200 mg twice daily or placebo in EM-I. N values (placebo/elagolix 150 mg once daily/elagolix 200 mg twice daily): month 1: 348/224/219; month 3: 314/216/198; month 6: 246/170/161. The mean difference from placebo is indicated for p < 0.05 (*), p < 0.01 (**), p < 0.001 (***). Source: Reprinted from Surrey and colleagues, Copyright © 2019, with permission from Elsevier. BID, twice daily; LS, least squares; PROMIS, Patient-Reported Outcomes Measurement Information System, QD, once daily; SE, standard error.

Figure 3.

Gains in productive workplace hours per week over time in pooled data from EM-I and EM-II. Mean hours gained in workplace productivity, defined as −1 × LS mean change from baseline in hours of workplace 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, 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.

Figure 4.

Gains in household productivity per week over time in pooled data from EM-I and EM-II. 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, 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.