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Esmya® Efficacy

BLEEDING CONTROL MAINTAINED DURING OFF-TREATMENT

Amenorrhoea Maintenance at the end of each course

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

Percentage of patients achieving amenorrhea at the end of each treatment course

Adapted from Donnez 2015, in press

Per protocol population 4**
N, number of patients with non-missing amenorrhoea assessments
*Amenorrhoea was defined as no more than one day of spotting within a 35-day interval
**All patients who have not withdrawn prior to receiving at least 56 days of study medication during treatment course 4 and had not reported any major protocol deviations

Reference:

1.Donnez J, et al. 2015, in press. [PEARL IV, Part 2].

Rapid & sustained bleeding Control

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

 

Percentage of patients with controlled bleeding at the end of each treatment course

Adapted from Donnez 2015, in press
Per protocol population 4**
N, number of patients with non-missing controlled bleeding assessments
*Controlled bleeding was defined as no episodes of heavy bleeding and a maximum of 8 days of bleeding (not including days of spotting) during the last 56 days of a treatment course
**All patients that had not withdrawn prior to receiving at least 56 days of study medication during treatment course 4 and had not reported any major protocol deviations

Reference:

1.Donnez J, et al. 2015, in press. [PEARL IV, Part 2].

 

Bleeding Control Maintained during off-treatment

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.

Intensity of menstrual bleeding (PBAC score) during off-treatment period

Adapted from Donnez 2015, in press
Full analysis set 1
Menstrual Bleeding is defined as the first 8 days of menses are included in the total PBAC score
PBAC, Pictorial Bleeding Assessment Chart; UPA, ulipristal acetate

 

Reference:

1.Donnez J, et al. 2015, in press. [PEARL IV, Part 2].

Rapid achievement of amenorrhea

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.

Time to amenorrhea for patients on UPA 5mg

Adapted from Donnez 2015, in press
Amenorrhoea was defined as no more than one day of spotting within a 35-day interval; N, Number of subjects with non-missing amenorrhoea assessments; UPA, ulipristal acetate

 

Reference:

1.Donnez J, et al. 2015, in press. [PEARL IV, Part 2].

 

Anemia Correction

Esmya® can help to correct anaemia1.
With iron supplementation, anemia was eventually corrected in most patients on Placebo, Esmya®(UPA 5 mg) and UPA 10 mg.

Patients with corrected anemia in placebo or UPA groups at week 13 (ITT)

Adapted from Donnez J., et al. “Ulipristal acetate versus placebo for fibroid treatment before surgery.” N Engl J Med. 2012 Feb 2;366(5):409-20.

Hb, haemoglobin; ITT, intent-to-treat; UPA, ulipristal acetate.
All patients had Hb ≤10.2 g/dL at screening.

 

Reference :

  1. Donnez J., et al.“Ulipristal acetate versus placebo for fibroid treatment before surgery.” N Engl J Med. 2012 Feb 2;366(5):409-20

Reduction in uterine fibroid volume

Esmya® progressively shrinks fibroids, with reductions maintained even after treatment1,2.

Median change from screening in total fibroid volume

Adapted from Donnez 2015, In press
Median change from screening in total fibroid volume†† (per protocol population 4**)
N, number of patients with assessments available
†After one menses following the treatment course
‡Follow-up 3 months post-treatment
††Volume of 3 largest fibroids combined
**All patients that had not withdrawn prior to receiving at least 56 days of study medication during treatment course 4 and had not reported any major protocol deviations

Reference:

1.Donnez J, et al. 2015, in press. [PEARL IV, Part 2].

  1. Esmya® SmPC. May 2015

 

Improvement in quality of life (QoL)

Esmya® progressively improves QoL related to UF symptoms1.
UF symptom-related QoL was substantially improved vs. baseline at the end of each course1.
Women maintained these improvements in QoL, even in the off-treatment period1.

UFS-QoL: Median UF symptom severity score (SSS)*

Adapted from Donnez 2015, in press
UFS-QoL: Median symptom severity score (SSS)* (full analysis set 1†)
N, patients with non-missing assessments; SSS, symptom severity score; UFS-QoL, Uterine Fibroid Symptom and Quality of Life questionnaire
*The SSS measures symptoms, such as bleeding, abdominal pressure, urination frequency and fatigue (range 0 to 100, the lower the score the less severe the symptoms)
**Follow-up 3 months post-treatment
†All patients that received study treatment at least once for treatment course 1

1.Donnez J, et al. 2015, in press. [PEARL IV, Part 2].

References

  • 125 Reference 1 - Esmya® SmPC. May 2015.

Reduction in pain

Esmya® progressively reduces pain.
Median pain scores (VAS) were substantially decreased vs baseline at the end of each treatment course.
Women maintained the improvements in pain score, even in the off-treatment period.

Median pain score (VAS)

Adapted from Donnez 2015, in press
Median pain score (VAS) (full analysis set 1†)
N, patients with non-missing assessments; VAS, visual analogue scale
‡Follow-up 3 months post-treatment
†All patients that received study treatment at least once for treatment course 1

 

Reference:

1.Donnez J, et al. 2015, in press. [PEARL IV, Part 2].

 

 

Amenorrhoea and fibroid reduction

The majority of Esmya® patients experience both amenorrhoea and clinically significant fibroid reduction with at least 4 intermittent courses1.
It is estimated that out of 100 women more than 95 would benefit from four intermittent treatment courses of Esmya®1..
Percentage of patients with amenorrhoea and/or a clinically significant reduction (>=25%) in fibroid volume.

 

Subjects_in_amenorrhoea

Adapted from Donnez 2015, in press
Full analysis set 1*
*All patients that received study treatment at least once for treatment course 1

Reference:

1.Donnez J, et al. 2015, in press. [PEARL IV, Part 2].

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