With Esmya^® amenorrhea rates were achieved rapidly over successive treatment courses.
Amenorrhea rates were achieved between 4 to 6 days after the start of each Esmya^® treatment course.

With Esmya^®, PBAC (Pictorial Bleeding Assessment Chart) showed a marked progressive reduction in menstrual bleeding. PBAC score is a method to quantify blood loss at women. PBAC scores > 100 indicates menorrhagia.

Esmya^® maintains bleeding control over successive treatment courses.
More than 90% of women had controlled bleeding* at the end of each treatment course.

Esmya^® maintains amenorrhoea over successive treatment courses.
More than 80% of women achieved amenorrhoea* by the end of the fourth course of Esmya^®.

The safety profile of Esmya® is supported by extensive clinical studies and real-life experience. The vast majority of adverse events during intermittent and pre-operative therapy with Esmya® were mild to moderate and resolved spontaneously ^7,44.

Menopausal-like adverse events decreased in frequency during intermittent therapy.
Hot flushes decreased from 5.7% to 2.8% between the first and fourth courses⁷.

When comparing repeated treatment courses, overall adverse reactions rate was lower in subsequent treatment courses than during the first course and each adverse reaction was less frequent or remained in the same frequency category (except for dyspepsia which was classified as uncommon in treatment course 3 based on one patient occurrence).

In 10-15% of patients, thickening of the endometrium (> 16 mm by ultrasound or MRI at end of treatment) was observed with ulipristal acetate by the end of the first 3-month treatment course. In subsequent treatment courses, endometrial thickening was less frequently observed (4.9% and 3.5% of patients by the end of second and fourth treatment course, respectively). The endometrial thickening  reverses when treatment is stopped and menstrual periods resume.

Educational material to inform gynaecologists and pathologists about the appearance of the endometrium when PAEC changes occur and how they are best managed can be found here.

If sending tissue specimens to your local pathology departments, it is advisable to inform them that the patient has been taking Esmya® as this will indicate that PAEC or endometrial thickening may be observed.

In all Phase III studies including repeated intermittent treatment studies, a total of 7 cases of hyperplasia were observed out of 789 patients with adequate biopsies (0.89%). The vast majority spontaneously reversed to normal endometrium after resumption of menstruation during the off-treatment period. The incidence of hyperplasia did not increase with repeated treatment courses. The observed frequency is in line with control groups and prevalence reported in literature for symptomatic pre-menopausal women of this age group (mean of 40 years).

Ulipristal acetate has a specific pharmacodynamic action on the endometrium:

Changes in the histology of the endometrium may be observed in patients treated with ulipristal acetate. These changes reverse after treatment cessation.

These histological changes are denoted as “Progesterone Receptor Modulator Associated Endometrial Changes” (PAEC) and should not be mistaken for endometrial hyperplasia. Evidence indicates PRM-Associated Endometrial Changes (PAEC) are harmless and quickly reversible⁴¹

See EU SmPC for further guidance on how to monitor the endometrium.

Endometrial findings

In all Phase III studies including repeated intermittent treatment studies, a total of 7 cases of hyperplasia were observed out of 789 patients with adequate biopsies (0.89%). The vast majority spontaneously reversed to normal endometrium after resumption of menstruation during the off-treatment period. The incidence of hyperplasia did not increase with repeated treatment courses. The observed frequency is in line with control groups and prevalence reported in literature for symptomatic pre-menopausal women of this age group (mean of 40 years).

PAEC viewer

Educational material to inform gynaecologists and pathologists about the appearance of the endometrium when PAEC changes occur and how they are best managed can be found at the following sources:

https://esmya.com/educationals-resources/

If sending tissue specimens to your local pathology departments, it is advisable to inform them that the patient has been taking Esmya® as this will indicate that PAEC or endometrial thickening may be observed.

Endometrial thickening

In 10-15% of patients, thickening of the endometrium (> 16 mm by ultrasound or MRI at end of treatment) was observed with ulipristal acetate by the end of the first 3-month treatment course. In subsequent treatment courses, endometrial thickening was less frequently observed (4.9% and 3.5% of patients by the end of second and fourth treatment course, respectively). The endometrial thickening  reverses when treatment is stopped and menstrual periods resume.