Clinically Meaningful Reduction in Dyspareunia Is Associated With Significant Improvements in Health-Related Quality of Life Among Women With Moderate to Severe Pain Associated With Endometriosis: A Pooled Analysis of Two Phase III Trials of Elagolix.

Abstract Background Dyspareunia experienced by women diagnosed with endometriosis is associated with a decreased health-related quality of life (HRQoL). Aim We evaluated the relationship of clinically meaningful improvements in dyspareunia with HRQoL changes among women with endometriosis. Methods This was a post hoc analysis of pooled data from the phase III ELARIS-I and ELARIS-II clinical trials. Women aged 18–49 years with moderate to severe endometriosis-associated pain were randomized to placebo, elagolix 150 mg once daily, or elagolix 200 mg twice daily. HRQoL was measured using the validated Endometriosis Health Profile-30 questionnaire (EHP-30), consisting of 5 core domains and a sexual intercourse modular domain. Dyspareunia was ranked 0–3 (none, mild, moderate, or severe) or not applicable using a daily eDiary and averaged monthly. A woman with a clinically meaningful dyspareunia response (dyspareunia responder) was defined as a woman with a reduction from the baseline in dyspareunia score greater than or equal to a predetermined cutoff while maintaining stable/decreased analgesic use. Outcomes Dyspareunia response impact on EHP-30 scores was determined at 3 and 6 months using multivariate linear regression controlling for age, baseline EHP-30 scores, and dysmenorrhea and non-menstrual pelvic pain symptom severity. Results Analysis included 1,368 women with a mean age of 32.2 years. Dyspareunia responders had significant improvements vs non-responders in all adjusted mean EHP-30 domain scores at months 3 and 6 (control and powerlessness: −17.8 and −18.5; emotional well-being: −10.0 and −10.4; pain: −15.3 and −15.7; self-image: −11.4 and −12.8; social support: −14.3 and −14.0; and sexual intercourse: −18.1 and −19.7; all P  Clinical Implications Dyspareunia improvements are associated with both personal and psychological benefits. Strengths & Limitations This study involved a large sample of women from a well-defined patient population to provide statistical power in evaluating the results. As such, the findings may not be generalizable in a real-world setting. Although the perception of dyspareunia and its severity and the associated effect on HRQoL was subjective, the use of a large patient sample was used to minimize potential issues with this limitation. Conclusion Clinically meaningful responses in dyspareunia are associated with improvements across multiple HRQoL domains among women with endometriosis. Agarwal SK, Soliman AM, Pokrzywinski RM, et al. Clinically Meaningful Reduction in Dyspareunia Is Associated with Significant Improvements in Health-Related Quality of Life Among Women with Moderate to Severe Pain Associated with Endometriosis: A Pooled Analysis of Two Phase III Trials of Elagolix. J Sex Med 2020;XX:XXX–XXX.