Design: To report the 48-month bone mineral density data of a phase 3 study evaluating the long-term safety of elagolix 200 mg twice daily (ELA) with add-back therapy (AB, estradiol 1 mg/0.5 mg norethindrone acetate) for treatment of endometriosis-associated pain (EAP; NCT03213457).
Setting: N/A
Patients or Participants: Premenopausal women with moderate to severe EAP
Interventions: Randomized 4:1:2 to 12-month double-blinded treatment with ELA+AB, ELA for 6 months followed by ELA+AB for 6 months, or placebo. Following blinded treatment, all patients received open-label ELA+AB for an additional 36 months.
Measurements and Main Results: Randomized 4:1:2 to 12-month double-blinded treatment with ELA+AB, ELA for 6 months followed by ELA+AB for 6 months, or placebo. Following blinded treatment, all patients received open-label ELA+AB for an additional 36 months.
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Table. Mean Percent Change From Baseline in BMD at 48 Months in Women With EAP Treated With ELA+AB for 48 months |
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Percent Change From Baseline |
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Anatomic Region |
n |
LS mean ± SE |
95% CI |
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Lumbar spine |
37 |
−0.33±0.55 |
−1.42, 0.77 |
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Total hip |
36 |
0.74±0.39 |
−0.05, 1.53 |
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Femoral neck |
36 |
−0.24±0.64 |
−1.52, 1.04 |
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LS, least squares |
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Conclusion: This 48-month study was the longest evaluation of ELA+AB to date in patients with EAP, and this analysis showed that ELA+AB had minimal long-term impact on BMD in premenopausal women with moderate-to-severe EAP. Combined with previously reported efficacy data, these data support that ELA+AB may provide a long-term, therapeutic option for moderate to severe EAP through 48 months.
Kim, JH*1, Simon, JA2, Miller, P3, Ng, J4, Chan, A4, Thomas, J4, Snabes, M4. 1OBGYN, Columbia Irving Medical Center - New York Presbyterian Hospital, New York, NY; 2Obstetrics and Gynecology, IntimMedicine Specialists, Washington, DC; 3OBGYN, Prisma Health, Greenville, SC; 4Abbvie, Chicago, IL