TY - JOUR
T1 - Impact of elagolix on work loss due to endometriosis-associated pain
T2 - estimates based on the results of two phase III clinical trials
AU - Pokrzywinski, Robin M.
AU - Soliman, Ahmed M.
AU - Chen, Jun
AU - Snabes, Michael
AU - Diamond, Michael P.
AU - Surrey, Eric
AU - Coyne, Karin S.
N1 - Funding Information:
R.M.P. is an employee of Evidera, a contract research organization that received funds from AbbVie to conduct this analysis. A.M.S. has nothing to disclose. J.C. is an employee of Evidera, a contract research organization that received funds from AbbVie to conduct this analysis. M.S. is an employee of and owns stock/stock options in AbbVie. M.P.D. has received funds for his institution from AbbVie and was an investigator for AbbVie. E.S. was an AbbVie study investigator, has served on medical advisory boards, and has been a member of the speakers' bureau for AbbVie and Ferring Laboratories. K.S.C. is an employee of Evidera, a contract research organization that received funds from AbbVie to conduct this analysis.AbbVie funded the study and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. Medical writing and editing were provided by Dr. Phillip Leventhal (Evidera) and paid for by AbbVie.
Publisher Copyright:
© 2019 The Authors
PY - 2019/9
Y1 - 2019/9
N2 - Objective: To estimate the impact of elagolix on work loss due to endometriosis-associated pain. Design: Post hoc analysis of data from the Elaris I and II clinical trials. Setting: Not applicable. Patient(s): Employed women ages 18–49 years with moderate-to-severe endometriosis-associated pain. Intervention(s): In the two trials, participants were randomized to 6 months of treatment with placebo, elagolix 150 mg once a day, or elagolix 200 mg twice a day. Main Outcome Measure(s): Data on planned work hours, presenteeism, absenteeism, and total work loss (absenteeism + presenteeism) at baseline and month 3 were collected using the Health-Related Productivity Questionnaire. Result(s): This analysis included employed participants from EM-I (n = 672) and EM-II (n = 626). Between baseline and month 3, compared with participants treated with placebo, participants treated with elagolix 150 mg once a day gained > 2 hours total work/week (EM-I, 2.20 ± 1.03; EM-II, 2.65 ± 1.14). Participants treated with 200 mg twice a day gained > 4 hours total work/week (EM-I, 4.91 ± 1.04; EM-II, 4.64 ± 1.14). Both absenteeism and presenteeism were reduced, although most of the gain was due to reduced presenteeism. Estimated cost savings after 6 months of treatment with elagolix were > $1,500 U.S. at 150 mg once a day and > $3,300 U.S. at 200 mg twice a day. Conclusion(s): Compared with placebo, treating moderate-to-severe endometriosis-associated pain with elagolix reduced absenteeism and improved productivity in employed women, which should result in cost savings. Clinical Trial Number(s): NCT01620528 (EM-I) and NCT01931670 (EM-II).
AB - Objective: To estimate the impact of elagolix on work loss due to endometriosis-associated pain. Design: Post hoc analysis of data from the Elaris I and II clinical trials. Setting: Not applicable. Patient(s): Employed women ages 18–49 years with moderate-to-severe endometriosis-associated pain. Intervention(s): In the two trials, participants were randomized to 6 months of treatment with placebo, elagolix 150 mg once a day, or elagolix 200 mg twice a day. Main Outcome Measure(s): Data on planned work hours, presenteeism, absenteeism, and total work loss (absenteeism + presenteeism) at baseline and month 3 were collected using the Health-Related Productivity Questionnaire. Result(s): This analysis included employed participants from EM-I (n = 672) and EM-II (n = 626). Between baseline and month 3, compared with participants treated with placebo, participants treated with elagolix 150 mg once a day gained > 2 hours total work/week (EM-I, 2.20 ± 1.03; EM-II, 2.65 ± 1.14). Participants treated with 200 mg twice a day gained > 4 hours total work/week (EM-I, 4.91 ± 1.04; EM-II, 4.64 ± 1.14). Both absenteeism and presenteeism were reduced, although most of the gain was due to reduced presenteeism. Estimated cost savings after 6 months of treatment with elagolix were > $1,500 U.S. at 150 mg once a day and > $3,300 U.S. at 200 mg twice a day. Conclusion(s): Compared with placebo, treating moderate-to-severe endometriosis-associated pain with elagolix reduced absenteeism and improved productivity in employed women, which should result in cost savings. Clinical Trial Number(s): NCT01620528 (EM-I) and NCT01931670 (EM-II).
KW - Endometriosis
KW - absenteeism
KW - presenteeism
KW - productivity
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U2 - 10.1016/j.fertnstert.2019.04.031
DO - 10.1016/j.fertnstert.2019.04.031
M3 - Article
C2 - 31227284
AN - SCOPUS:85067285131
SN - 0015-0282
VL - 112
SP - 545
EP - 551
JO - Fertility and sterility
JF - Fertility and sterility
IS - 3
ER -