Elagolix shows long-term efficacy

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.

[email protected]

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.

[email protected]

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.

[email protected]

SOURCE: Surrey ES et al. ACOG 2018, Abstract 11OP.