OBJECTIVES

To quantify changes in health-related quality of life (HRQOL) among patients with endometriosis who experience a clinically meaningful reduction in dyspareunia.

METHODS

This was a post-hoc analysis of pooled data from ELARIS-I and ELARIS-II phase III randomized placebo-controlled clinical trials where women aged 18 to 49 with moderate-to-severe pain associated with endometriosis were randomized to placebo, elagolix 150 mg once daily and Elagolix 200 mg twice daily for 6 months. HRQOL was measured using the validated Endometriosis Health Profile 30 questionnaire (EHP-30) that is comprised of 5 core domains and the sexual intercourse modular domain where lower scores reflect better HRQOL (range 0-100). Dyspareunia was measured using daily e-diary that asked patients to rank their dyspareunia as none (0), mild (1) moderate (2), severe (3) or not applicable, which was averaged monthly. A patient was considered to achieve clinically meaningful dyspareunia response if their reduction from baseline dyspareunia score was equal to or greater than a cut-off determined from a receiver operating characteristics curve while maintaining a stable or decreased analgesic use. Impact of achieving the dyspareunia response threshold on EHP-30 domains’ scores was examined at month 3 and month 6 using multivariate linear regression controlling for age and baseline EHP-30 scores.

RESULTS

Analysis included 1686 patients with mean age of 32.3 years. Achieving the dyspareunia responder threshold was associated with significant improvements in all domain scores of EHP-30 at month 3 (pain: -14.7, control and powerlessness: -17.2, social support: -13.6, emotional well-being: -9.5, self-image: -10.8 and sexual intercourse: -17.9; all p<0.0001). Larger improvements were observed at month 6 (pain: -15.4, control and powerlessness: -18.2, social support: -13.6, emotional well-being: -10.1, self-image: -12.5 and sexual intercourse: -19.6; all p<0.0001).

CONCLUSIONS

Achieving clinically meaningful response in dyspareunia is associated with an improvement in multiple dimensions of HRQOL among endometriosis patients.