In two phase 3 extension studies, elagolix demonstrated a long-term sustained reduction in average monthly menstrual pelvic pain, nonmenstrual pelvic pain and painful intercourse in women with endometriosis, without compromising safety or tolerability, according to a press release from AbbVie.
“Currently, physicians have limited options for the long-term medical management of endometriosis and are in need of additional treatment options to help manage this debilitating disease,” Eric Surrey, MD, lead investigator and medical director of the Colorado Center of Reproductive Medicine, told Healio Internal Medicine.
Elagolix is an investigational oral gonadotropin-releasing hormone antagonist, according to AbbVie.
Surrey and colleagues conducted two extension studies (Elaris EM-III and Elaris EM-IV) to determine if two doses of elagolix — 150 mg once daily and 200 mg twice daily — are safe and effective long-term options for the management of endometriosis with associated pain. The studies assessed an additional 6 months of treatment each for a total of 12 months in women aged between 18 and 49 years who were surgically diagnosed with endometriosis and had moderate-to-severe pain related to endometriosis at baseline.
The researchers evaluated efficacy by calculating the reduction of participants’ average monthly menstrual pain and nonmenstrual pelvic pain scores, which were measured using the Daily Assessment of Endometriosis Pain scale. They assessed safety by evaluating adverse events and changes in bone mineral density.
Surrey and colleagues found that across both extension studies and for both elagolix doses, menstrual pain and nonmenstrual pelvic pain were reduced after 6 months of treatment and maintained over an additional 6 months. Participants receiving the 200-mg dose of elagolix reported more painful intercourse after 12 months than those receiving the 150-mg dose.
Overall, 4% to 8% of participants experienced new incidences of hot flush. At month 12, there was a dose-dependent average decline from baseline in bone mineral density (0.6% and 1.1% with 150 mg in EM-III and EM-IV, respectively; and 3.6% and 3.9% with 200 mg in EM-III and EM-IV, respectively).
Elagolix showed that its safety and tolerability was consistent with the anticipated effects of reduced estradiol levels and did not indicate new safety concerns with long-term use, according Surrey.
“Elagolix has the potential to be an important oral treatment option for women suffering from the most prevalent symptoms of endometriosis,” Surrey said.
“Currently, physicians may consider alternative means of treatment that are not specifically designed to treat endometriosis or women living with endometriosis may endure repetitive and costly surgical procedures,” he added.
“The American Society for Reproductive Medicine treatment guidelines recommend the use of medical management options to treat endometriosis-associated pain and avoid multiple surgeries. If approved by the FDA, elagolix will be the first new medical management treatment option for endometriosis-associated pain in more than a decade.” – by Alaina Tedesco
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