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AUSTIN, TEX. – A new treatment for endometriosis-related pain, Elagolix, showed evidence of being effective long term, according to a study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
Elagolix, an oral nonpeptide gonadotropin-releasing hormone (GnRH) antagonist, manufactured by AbbVie, would be the first treatment of its kind if approved by the Food and Drug Administration, and would fulfill a needed relief for a more tolerable approach to severe endometriosis patients, according to presenter Eric S. Surrey, MD, medical director at the Colorado Center of Reproductive Medicine, Lone Tree.
“There have been no new medications approved for a long time for systematic endometriosis and there is a huge gap because the current options are expensive, and they are often injectable drugs,” said Dr. Surrey in an interview. “This would be an oral agent, which would be fabulous because it allows for a lot of flexibility and for many patients this could be much less concerning than using something long acting.”
To test the long-term effects of Elagolix, investigators studied 570 women with moderate to severe endometriosis-related pain who had gathered to participate in a previous phase 3, randomized, placebo-controlled trial concerning the drug’s effectiveness.
In the two extension studies, all participants were given either a 150- or 200-mg dose of Elagolix.
Average age of each patient group was between 31 and 34 years, and all groups were majority white, with a mean length of time from surgical diagnosis ranging from 45.5 to 56.6 months.
Patient improvements in dysmenorrhea and nonmenstrual pelvic pain continued between the first 6 months and 12 months of treatment, with a decrease of 46%-77% in the overall number of analgesics taken per day.
After 12 months of consecutive treatment, patients given 150 mg of Elagolix saw mean dysmenorrhea scores improve by 49%-53% from baseline, and by 82% for those at 200 mg, with certain expected adverse events, according to Dr. Surrey.
One of the most common adverse events associated with Elagolix was hot flashes, an unsurprising finding for Dr. Surrey and his colleagues considering Elagolix is a drug that lowers estrogen levels. However, any hot flashes patients experienced during the trial were still better than those associated with current medications, according to Dr. Surrey.
“In this extension study nobody dropped out because of hot flashes in the additional 6-month extension time,” Dr. Surrey explained. “If you look at the gold standard drug for endometriosis now, which is a GnRH agonist, which are highly available and are either injectable or implants, [patients taking these drugs] can have very severe hot flashes that require additional medication to alleviate the hot flashes at the same time.”
Patients did also experience some loss in bone density; however, Dr. Surrey argues the frequency and level of these adverse events is still better than current treatment options. One patient was required to discontinue the trial for bone density loss.
Currently, Elagolix is under FDA priority review, and if approved will be the first oral endometriosis treatment approved in over a decade, according to Dr. Surrey.
Dr. Surrey and several coauthors receive financial support from AbbVie as consultants, board members, and/or employees. Dr. Surrey and Dr. Taylor receive additional support from companies including Pfizer, Bayer, and Obseva.
SOURCE: Surrey ES et al. ACOG 2018, Abstract 11OP.
Having had the opportunity to review Dr. Eric Surrey's abstract for this year's annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists, entitled "Long-term Safety and Efficacy of Elagolix Treatment in Women With Endometriosis-associated Pain," I believe use of Elagolix, an oral nonpeptide gonadotropin-releasing hormone (GnRH) antagonist, is a much-needed advancement in the long-term treatment of endometriosis-related pain. The fact that it is an oral medication, thus, not requiring a monthly or 3-month injection as does Lupron Depot (leuprolide acetate), the most popular GnRH agonist in the United States, is advantageous both for the patient and the busy office staff.
While I certainly understand that it is easy to compare data regarding bone loss in the use of an oral antagonist, Elagolix, with historical data with the GnRH agonist and note a lessening of bone loss in the Elagolix patients, it would be interesting to compare bone loss in patients utilizing Elagolix with bone loss in those treated with GnRH-agonist plus add-back therapy. Many practitioners will utilize progesterone supplementation or estrogen/progesterone supplementation when using GnRH-agonist therapy to decrease this risk. Furthermore, it would be interesting, in the future, to evaluate the impact on efficacy and bone loss if progesterone and estrogen/progesterone add-back were utilized in Elagolix therapy.
While I certainly realize and deeply respect Dr. Surrey's vast experience as both a clinical researcher and clinician utilizing a GnRH-agonist regimen, I am curious as to the basis of Dr. Surrey's comments regarding less severe hot flashes in comparison to GnRH-agonist treatment. I am not aware of any head-to-head studies comparing hot flashes between GnRH agonists (in particular, leuprolide acetate) and Elagolix.
Without a side-by-side comparison utilizing a validated scoring system, I find it hard to accept this conclusion.
Nevertheless, after reviewing this study and Dr. Surrey's comments, I look forward to utilizing Elagolix in my practice for long-term treatment of endometriosis-related pain.
Charles Miller, MD, is a minimally invasive gynecologic surgeon in Naperville, Ill., and a past president of the AAGL. He is a consultant and involved in research for AbbVie.
Having had the opportunity to review Dr. Eric Surrey's abstract for this year's annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists, entitled "Long-term Safety and Efficacy of Elagolix Treatment in Women With Endometriosis-associated Pain," I believe use of Elagolix, an oral nonpeptide gonadotropin-releasing hormone (GnRH) antagonist, is a much-needed advancement in the long-term treatment of endometriosis-related pain. The fact that it is an oral medication, thus, not requiring a monthly or 3-month injection as does Lupron Depot (leuprolide acetate), the most popular GnRH agonist in the United States, is advantageous both for the patient and the busy office staff.
While I certainly understand that it is easy to compare data regarding bone loss in the use of an oral antagonist, Elagolix, with historical data with the GnRH agonist and note a lessening of bone loss in the Elagolix patients, it would be interesting to compare bone loss in patients utilizing Elagolix with bone loss in those treated with GnRH-agonist plus add-back therapy. Many practitioners will utilize progesterone supplementation or estrogen/progesterone supplementation when using GnRH-agonist therapy to decrease this risk. Furthermore, it would be interesting, in the future, to evaluate the impact on efficacy and bone loss if progesterone and estrogen/progesterone add-back were utilized in Elagolix therapy.
While I certainly realize and deeply respect Dr. Surrey's vast experience as both a clinical researcher and clinician utilizing a GnRH-agonist regimen, I am curious as to the basis of Dr. Surrey's comments regarding less severe hot flashes in comparison to GnRH-agonist treatment. I am not aware of any head-to-head studies comparing hot flashes between GnRH agonists (in particular, leuprolide acetate) and Elagolix.
Without a side-by-side comparison utilizing a validated scoring system, I find it hard to accept this conclusion.
Nevertheless, after reviewing this study and Dr. Surrey's comments, I look forward to utilizing Elagolix in my practice for long-term treatment of endometriosis-related pain.
Charles Miller, MD, is a minimally invasive gynecologic surgeon in Naperville, Ill., and a past president of the AAGL. He is a consultant and involved in research for AbbVie.
Having had the opportunity to review Dr. Eric Surrey's abstract for this year's annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists, entitled "Long-term Safety and Efficacy of Elagolix Treatment in Women With Endometriosis-associated Pain," I believe use of Elagolix, an oral nonpeptide gonadotropin-releasing hormone (GnRH) antagonist, is a much-needed advancement in the long-term treatment of endometriosis-related pain. The fact that it is an oral medication, thus, not requiring a monthly or 3-month injection as does Lupron Depot (leuprolide acetate), the most popular GnRH agonist in the United States, is advantageous both for the patient and the busy office staff.
While I certainly understand that it is easy to compare data regarding bone loss in the use of an oral antagonist, Elagolix, with historical data with the GnRH agonist and note a lessening of bone loss in the Elagolix patients, it would be interesting to compare bone loss in patients utilizing Elagolix with bone loss in those treated with GnRH-agonist plus add-back therapy. Many practitioners will utilize progesterone supplementation or estrogen/progesterone supplementation when using GnRH-agonist therapy to decrease this risk. Furthermore, it would be interesting, in the future, to evaluate the impact on efficacy and bone loss if progesterone and estrogen/progesterone add-back were utilized in Elagolix therapy.
While I certainly realize and deeply respect Dr. Surrey's vast experience as both a clinical researcher and clinician utilizing a GnRH-agonist regimen, I am curious as to the basis of Dr. Surrey's comments regarding less severe hot flashes in comparison to GnRH-agonist treatment. I am not aware of any head-to-head studies comparing hot flashes between GnRH agonists (in particular, leuprolide acetate) and Elagolix.
Without a side-by-side comparison utilizing a validated scoring system, I find it hard to accept this conclusion.
Nevertheless, after reviewing this study and Dr. Surrey's comments, I look forward to utilizing Elagolix in my practice for long-term treatment of endometriosis-related pain.
Charles Miller, MD, is a minimally invasive gynecologic surgeon in Naperville, Ill., and a past president of the AAGL. He is a consultant and involved in research for AbbVie.
AUSTIN, TEX. – A new treatment for endometriosis-related pain, Elagolix, showed evidence of being effective long term, according to a study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
Elagolix, an oral nonpeptide gonadotropin-releasing hormone (GnRH) antagonist, manufactured by AbbVie, would be the first treatment of its kind if approved by the Food and Drug Administration, and would fulfill a needed relief for a more tolerable approach to severe endometriosis patients, according to presenter Eric S. Surrey, MD, medical director at the Colorado Center of Reproductive Medicine, Lone Tree.
“There have been no new medications approved for a long time for systematic endometriosis and there is a huge gap because the current options are expensive, and they are often injectable drugs,” said Dr. Surrey in an interview. “This would be an oral agent, which would be fabulous because it allows for a lot of flexibility and for many patients this could be much less concerning than using something long acting.”
To test the long-term effects of Elagolix, investigators studied 570 women with moderate to severe endometriosis-related pain who had gathered to participate in a previous phase 3, randomized, placebo-controlled trial concerning the drug’s effectiveness.
In the two extension studies, all participants were given either a 150- or 200-mg dose of Elagolix.
Average age of each patient group was between 31 and 34 years, and all groups were majority white, with a mean length of time from surgical diagnosis ranging from 45.5 to 56.6 months.
Patient improvements in dysmenorrhea and nonmenstrual pelvic pain continued between the first 6 months and 12 months of treatment, with a decrease of 46%-77% in the overall number of analgesics taken per day.
After 12 months of consecutive treatment, patients given 150 mg of Elagolix saw mean dysmenorrhea scores improve by 49%-53% from baseline, and by 82% for those at 200 mg, with certain expected adverse events, according to Dr. Surrey.
One of the most common adverse events associated with Elagolix was hot flashes, an unsurprising finding for Dr. Surrey and his colleagues considering Elagolix is a drug that lowers estrogen levels. However, any hot flashes patients experienced during the trial were still better than those associated with current medications, according to Dr. Surrey.
“In this extension study nobody dropped out because of hot flashes in the additional 6-month extension time,” Dr. Surrey explained. “If you look at the gold standard drug for endometriosis now, which is a GnRH agonist, which are highly available and are either injectable or implants, [patients taking these drugs] can have very severe hot flashes that require additional medication to alleviate the hot flashes at the same time.”
Patients did also experience some loss in bone density; however, Dr. Surrey argues the frequency and level of these adverse events is still better than current treatment options. One patient was required to discontinue the trial for bone density loss.
Currently, Elagolix is under FDA priority review, and if approved will be the first oral endometriosis treatment approved in over a decade, according to Dr. Surrey.
Dr. Surrey and several coauthors receive financial support from AbbVie as consultants, board members, and/or employees. Dr. Surrey and Dr. Taylor receive additional support from companies including Pfizer, Bayer, and Obseva.
SOURCE: Surrey ES et al. ACOG 2018, Abstract 11OP.
AUSTIN, TEX. – A new treatment for endometriosis-related pain, Elagolix, showed evidence of being effective long term, according to a study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
Elagolix, an oral nonpeptide gonadotropin-releasing hormone (GnRH) antagonist, manufactured by AbbVie, would be the first treatment of its kind if approved by the Food and Drug Administration, and would fulfill a needed relief for a more tolerable approach to severe endometriosis patients, according to presenter Eric S. Surrey, MD, medical director at the Colorado Center of Reproductive Medicine, Lone Tree.
“There have been no new medications approved for a long time for systematic endometriosis and there is a huge gap because the current options are expensive, and they are often injectable drugs,” said Dr. Surrey in an interview. “This would be an oral agent, which would be fabulous because it allows for a lot of flexibility and for many patients this could be much less concerning than using something long acting.”
To test the long-term effects of Elagolix, investigators studied 570 women with moderate to severe endometriosis-related pain who had gathered to participate in a previous phase 3, randomized, placebo-controlled trial concerning the drug’s effectiveness.
In the two extension studies, all participants were given either a 150- or 200-mg dose of Elagolix.
Average age of each patient group was between 31 and 34 years, and all groups were majority white, with a mean length of time from surgical diagnosis ranging from 45.5 to 56.6 months.
Patient improvements in dysmenorrhea and nonmenstrual pelvic pain continued between the first 6 months and 12 months of treatment, with a decrease of 46%-77% in the overall number of analgesics taken per day.
After 12 months of consecutive treatment, patients given 150 mg of Elagolix saw mean dysmenorrhea scores improve by 49%-53% from baseline, and by 82% for those at 200 mg, with certain expected adverse events, according to Dr. Surrey.
One of the most common adverse events associated with Elagolix was hot flashes, an unsurprising finding for Dr. Surrey and his colleagues considering Elagolix is a drug that lowers estrogen levels. However, any hot flashes patients experienced during the trial were still better than those associated with current medications, according to Dr. Surrey.
“In this extension study nobody dropped out because of hot flashes in the additional 6-month extension time,” Dr. Surrey explained. “If you look at the gold standard drug for endometriosis now, which is a GnRH agonist, which are highly available and are either injectable or implants, [patients taking these drugs] can have very severe hot flashes that require additional medication to alleviate the hot flashes at the same time.”
Patients did also experience some loss in bone density; however, Dr. Surrey argues the frequency and level of these adverse events is still better than current treatment options. One patient was required to discontinue the trial for bone density loss.
Currently, Elagolix is under FDA priority review, and if approved will be the first oral endometriosis treatment approved in over a decade, according to Dr. Surrey.
Dr. Surrey and several coauthors receive financial support from AbbVie as consultants, board members, and/or employees. Dr. Surrey and Dr. Taylor receive additional support from companies including Pfizer, Bayer, and Obseva.
SOURCE: Surrey ES et al. ACOG 2018, Abstract 11OP.
REPORTING FROM ACOG 2018
Key clinical point: New treatment for endometriosis-related pain shows long-term efficacy.
Major finding: Pain significantly decreased in test groups, compared with placebo (P less than .05).
Data source: A phase 3, randomized trial of 570 women with moderate to severe endometriosis.
Disclosures: Dr. Surrey and several coauthors receive financial support from AbbVie as consultants, board members, and/or employees. Dr. Surrey and Dr. Taylor receive additional support from companies including Pfizer, Bayer, and Obseva.
Source: Surrey ES et al. ACOG 2018, Abstract 11OP.