LAUSR

BACKGROUND Endometriosis-related pain symptoms negatively impact health-related quality of life (HRQoL) and productivity. In fact, as endometriosis-related symptom severity and the number of symptoms experienced increases, HRQoL decreases. Dysmenorrhea and non-menstrual pelvic pain are prominent symptoms experienced by women with endometriosis and were shown to have improved with the oral, nonpeptide GnRH antagonist, elagolix. OBJECTIVE The objective of this post hoc analysis was to address the question, if patients show a clinical response (in dysmenorrhea or non-menstrual pelvic pain), do they also have improvements in HRQoL and in productivity? STUDY DESIGN This post hoc analysis used data from the Elaris Endometriosis (EM)-I and EM-II phase III, randomized, placebo-controlled studies. A surgical diagnosis of endometriosis (in the past 10 years), premenopausal, age 18-49 years, and moderate to severe endometriosis-associated pain were among the inclusion criteria for both trials. Women self-reported pain daily using a scale ranging from 0 (no pain) to 3 (severe pain); daily pain was assigned to either dysmenorrhea or non-menstrual pelvic pain based on self-reported bleeding on that particular day. In addition, their self-reported endometriosis-associated pain must have been an average of moderate or severe during the month leading to baseline for inclusion in the trial program. Patients were characterized as achieving a clinical response for dysmenorrhea or non-menstrual pelvic pain (i.e. "responder" or "nonresponder") which was defined as women who did not have an increase in analgesic use and who met the pain reduction score threshold at month 3. Pain reduction score thresholds were defined separately for dysmenorrhea and non-menstrual pelvic pain in the trial using receiver operating characteristics analysis. HRQoL was assessed using the Endometriosis Health Profile-30 (EHP-30); work productivity assessed using the Health-Related Productivity Questionnaire (HRPQ). RESULTS Women enrolled in EM-I (n=871) and EM-II (n=815) were included in this analysis. Patients with a clinical response during treatment to dysmenorrhea or non-menstrual pelvic pain also experienced a meaningful improvement in all domains of the EHP-30 at month 3. Patients who did not show a dysmenorrhea or non-menstrual pelvic pain clinical response at month 3 did not exhibit mean improvements in EHP-30 domain scores that indicate an EHP-30 responder. Productivity improved among dysmenorrhea clinical responders. In the EM-I study, clinical responders lost a total of 5.9 hours compared with a total of 13.0 hours for nonresponders of employment-related work at month 3 (p<0.0001). Among women in the EM-II study, a total of 4.1 hours and 10.4 employment-related hours were lost at month 3 for dysmenorrhea responders vs. nonresponders (p<0.001). Similar results were obtained when analyzed by non-menstrual pelvic pain responder status. CONCLUSION Women with moderate-to-severe endometriosis-related pain, who are clinical responders based on dysmenorrhea and non-menstrual pelvic pain, also experience significant and clinically meaningful improvement in HRQoL and productivity as measured by the EHP-30 and HRPQ, respectively.