BONE TURNOVER CHANGES IN WOMEN TREATED WITH ELAGOLIX OR PLACEBO DURING THE ELARIS EM-I AND EM-II TRIALS WHO DID NOT CONTINUE IN THE EXTENSION STUDIES
CANSAGE ePoster Library. Singh S. 09/27/19; 275244; eP-111
Sony Singh
Sony Singh
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Abstract
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Objective: To evaluate the effect of elagolix on bone turnover markers(BTMs) in women with endometriosis-associated pain who were treated for ≤6 months(M).Methods: Data were pooled from two 6M, randomized, placebo-controlled phase 3 trials evaluating two doses of elagolix (150mg once daily[QD] and 200mg twice daily[BID]). Women who prematurely discontinued treatment, declined to participate in, or did not qualify for the continuous use extension studies entered a Post-treatment Follow-up Period(PTFU) for ≤12M.Participants (N=296) were 18-49 year old women with moderate/severe endometriosis-associated pain. The BTM serum collagen type 1 cross-linked C-telopeptide (CTx) was collected at baseline, M3, M6, PTFU-M3, and PTFU-M6. PTFU-M12 BTM collection was only required for women with the greatest bone loss. Analysis included women with ≥ one on-treatment and one PTFU value who did not enroll in the extension studies. Data analyzed using one-way ANOVA.Results: Baseline CTx levels were similar across treatment groups. Compared to placebo, women receiving elagolix 200mg BID had significantly greater increases from baseline in mean CTx levels at M6 (mean change from baseline[SD]pg/ml: placebo=-34.04[115.62];150mgQD=5.44[148.41],p=0.177;200mg BID=179.16[217.79],p<0.001). Mean changes from baseline in CTx levels remained elevated and significantly greater than placebo through PTFU-M3 with elagolix 200mg BID (placebo=-37.29[103.98];150mgQD=-9.15[156.72],p=0.180;200mgBID=42.64[153.37],p<0.001). Mean CTx levels were decreased compared to baseline at PTFU-M6 across all treatment groups (placebo=-43.45[106.67];150mgQD=-29.60[171.08],p=0.565;200mgBID=-33.33[145.60], p=0.652). BTMs, osteocalcin and procollagen type 1 N-terminal propeptide exhibited similar patterns of change as CTx.Conclusions: In these women, treatment with elagolix resulted in dose-dependent increases in mean CTx levels during the 6-month treatment period. CTx levels decreased after elagolix discontinuation.Support: AbbVie
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