IMPACT OF ELAGOLIX ON HEALTH-RELATED QUALITY OF LIFE AMONG PATIENTS WITH MODERATE TO SEVERE ENDOMETRIOSIS-ASSOCIATED PAIN- ANALYSIS OF EQ-5D-5L DATA FROM A PHASE III RANDOMIZED CONTROLLED TRIAL
Author(s)
Agarwal SK1, Soliman AM2, Schwefel B3, Peloso P3, Surrey ES4, Taylor HS5
1Center for Endometriosis Research and Treatment, La Jolla, CA, USA, 2AbbVie, North Chicago, IL, USA, 3AbbVie Inc., North Chicago, IL, USA, 4Colorado Center for Reproductive Medicine, Lone Tree, CO, USA, 5Yale School of Medicine, New Haven, CT, USA
OBJECTIVES To evaluate the impact of elagolix, a novel oral gonadotropin-releasing hormone antagonist, on the health-related quality of life assessed by the EQ-5D-5L survey among patients with moderate-to-severe endometriosis-associated pain METHODS Premenopausal women with surgically-confirmed endometriosis and moderate-to-severe endometriosis-associated pain were randomized to placebo, elagolix 150mg once daily (QD) or elagolix 200mg twice daily (BID) in a 6-month, phase III placebo-controlled randomized trial. EQ-5D-5L was administered at baseline and months 1, 3 and 6 of treatment. Changes from baseline in EQ-5D-5L visual analog scale (VAS) and index scores (where “1” represents perfect health and “0” represents death) were compared between each elagolix dose and placebo using analysis of covariance while controlling for baseline scores RESULTS A total of 815 patients were randomized and dosed (n=360, 226 and 229 in placebo, elagolix 150mg QD and elagolix 200mg BID; respectively). Baseline mean VAS scores were not significantly different between treatment groups (66.79, 65.19 and 68.0 for placebo, elagolix 150mg QD and elagolix 200mg BID; respectively). Least square (LS) mean change from baseline at month 3 was significantly higher (i.e. better) for each elagolix dose compared to placebo (5.09, 9.65 and 12.3 for placebo, elagolix 150mg QD and elagolix 200mg BID respectively; each p<0.01). Similar results were observed at month 6 (each p<0.05). Mean index scores were similar at baseline (0.73, 0.72 and 0.75 for placebo, elagolix 150mg QD and elagolix 200mg BID; respectively). LS mean changes from baseline were higher (i.e. better) for each elagolix dose compared to placebo at month 3 (0.06, 0.09 and 0.1 for placebo, elagolix 150mg QD and elagolix 200mg BID respectively; each p<0.01) . Similarly, each elagolix dose had higher LS mean changes at month 6 (p<0.05 for elagolix 200mg BID only) CONCLUSIONS Both doses of elagolix significantly improved health-related quality of life measured by EQ-5D-5L among endometriosis patients
Conference/Value in Health Info
2018-05, ISPOR 2018, Baltimore, MD, USA
Value in Health, Vol. 21, S1 (May 2018)
Code
PIH25
Topic
Patient-Centered Research
Topic Subcategory
Health State Utilities, Patient-reported Outcomes & Quality of Life Outcomes
Disease
Reproductive and Sexual Health