Long-term safety and efficacy of elagolix treatment in women with endometriosis-associated pain: primary results from two phase 3 extension studies

Abstract

related surgery. Pharmacy costs accounted for 15.3% of total healthcare costs among endometriosis patients and 22.2% among controls. Endometriosis-related costs accounted for an average of $3,069 (22.4%) of total healthcare costs among endometriosis patients. CONCLUSIONS: Endometriosis places a significant economic and resource burden among women with Medicaid coverage. Costs and resource utilization in all measured categories were higher among patients than controls.

Elagolix in the treatment of endometriosis: impact beyond pain symptoms

“…The most common adverse events were hot flushes, headache and nausea, with 25-30%, 20-22% and 12-18% of patients in the 150 mg once daily group and 52-55%, 25-29% and 15-25% of patients in the 200 mg twice daily group experiencing these symptoms, respectively. 32 The majority of hot flushes were mild to moderate with discontinuation rates for hot flushes ranging from <1% for the lower dose group to <3% for the higher dose. 33 Positive efficacy results obtained in the pivotal trials led to the approval of elagolix for the management of moderate to severe pain associated with endometriosis.…”

“…16 The safety and efficacy of elagolix in the treatment of endometriosis have been evaluated in four phase 2 trials, 16,[29][30][31] two phase 3 trials and two phase 3 extension studies. 32,33 The initial phase 2 trials suggested that elagolix was effective for endometriosis-related pain and associated with an adequate safety profile. 16,[29][30][31] Based on the positive results obtained in the phase 2 studies, two phase 3 trials (Elaris Endometriosis I and II (EM-I and EM-II)) were conducted to further evaluate the efficacy and safety of elagolix in women with moderate to severe endometriosisassociated pain.…”

“…33 Treatment with elagolix for 12 months resulted in sustained reductions in dysmenorrhoea, nonmenstrual pelvic pain and dyspareunia. 32 Long-term elagolix treatment also had anticipated changes as a result of decreased oestradiol levels, including hot flushes, reduced bone mineral density and increased lipid levels. 32 The incidence of hot flush over 12 months of treatment was 30-55% (across EM-III/EM-IV and both doses).…”

“…32 Long-term elagolix treatment also had anticipated changes as a result of decreased oestradiol levels, including hot flushes, reduced bone mineral density and increased lipid levels. 32 The incidence of hot flush over 12 months of treatment was 30-55% (across EM-III/EM-IV and both doses). Bone mineral density loss was dose dependent and increased with duration of treatment.…”

“…33 In the extension studies, 1 patient in the 150 mg once daily group and 10 patients in the 200 mg twice daily group discontinued treatment (as required by the study protocol) because they experienced a greater than 8% decrease in bone mineral density from baseline. 32 The observed decreases in bone mineral density may not be completely reversible, and the impact of these losses on long-term bone health and risk of future fractures is unknown. 34 Phase 3 trials (NCT03213457, NCT03343067) are currently being conducted to assess the efficacy and safety of elagolix in combination with low-dose, addback hormonal therapy in women with endometriosis-related pain.…”