Elagolix reduced fatigue in patients with endometriosis
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Patients with moderate-to-severe endometriosis and received elagolix had fewer fatigue symptoms according to findings presented at the American College of Obstetrics and Gynecology Annual Clinical and Scientific Meeting.
“Elagolix is a short-acting molecule that blocks endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland,” Michael P. Diamond, MD, professor and chair of the department of obstetrics and gynecology at Augusta University in Georgia, told Healio Family Medicine in an email interview about his presentation. “It works by partially lowering the level of ovarian sex hormones in the body and allows for dose-dependent modulation of estradiol concentrations.”
To evaluate the effect elagolix (AbbVie) has on fatigue among patients with endometriosis, Diamond and colleagues recruited 872 premenopausal women with moderate-to-severe endometriosis-related pain who had a surgically-confirmed diagnosis for a phase 3 double-blind, randomized, placebo-controlled trial. For 6 months, participants received either a placebo, 150 mg of elagolix once daily or 200 mg of elagolix twice daily. Using the Patient Reported Outcome Measurement Information System (PROMIS), researchers assessed fatigue in patients and converted the raw scores to T-scores. A standard deviation (SD) of 10 was set for the general population and T-scores were standardized using a mean of 50.
According to Diamond, mean T-scores for patients taking placebo, elagolix 150 mg once daily and elagolix 200 mg twice daily were more than one SD worse than the population average at baseline assessment.
Researchers observed greater improvement from the T-scores for elagolix 150 mg once daily and elagolix 200 mg twice daily (least squared [LS] mean change, –6.26 and –8.84, respectively; all P < .05) at the 3-month assessment when compared with placebo (LS mean change, –4.61). Furthermore, the improvements identified at the 3-month assessment continued at 6 months (all P < .01).
“The phase 3 studies for elagolix are complete and the FDA is expected to complete its review of elagolix in endometriosis in Q3 of 2018,” Diamond said in the interview. “If approved by the FDA, elagolix will be the first FDA approved oral treatment for endometriosis-associated moderate to severe endometriosis pain in over a decade.” -by Marley Ghizzone
Reference: Diamond MP, et al. Elagolix reduces fatigue in patients with moderate-to-severe endometriosis pain. Presented at: American College of Obstetrics and Gynecology Annual Meeting; April 27-30, 2018; Austin, Texas.
Disclosures: Diamond has reported institutional research support from AbbVie and ObsEva. He is on Bayer board of directors and on the consultant/advisory board for Seikagaku. Diamond also has ownership interest in Advanced Reproductive Care, including stock, stock options, patent or other intellectual property. Please see the abstract for all other authors relevant financial disclosures.