Effectiveness of dienogest in improving quality of life in Asian women with endometriosis (ENVISIOeN): interim results from a prospective cohort study under real-life clinical practice

Abstract

Background: Dienogest has been shown to substantially improve endometriosis-associated symptoms such as debilitating chronic pelvic pain, and in turn, health-related quality of life (HRQoL). To date, there is no data on patient-reported outcomes reflecting the real-world practice in Asia where endometriosis is a relevant health, social and economic burden. This non-interventional, multi-center, prospective study aims to investigate the influence of dienogest on HRQoL.

Methods: Asian women received dienogest (2 mg/daily) and were followed for 24 months. The effectiveness of dienogest to improve HRQoL and endometriosis-associated pelvic pain (EAPP) was assessed by patient-reported outcomes. HRQoL, especially the "pain" domain as primary endpoint, was evaluated with the Endometriosis Health Profile-30 (EHP-30) questionnaire. The numeric rating scale served to determine changes in the severity of EAPP. Within the presented interim analysis (data cut-off: 2017-11-27), the mean changes in EHP-30 and EAPP scores from baseline to 6 months upon availability of the data were evaluated. Treatment-emergent adverse events (TEAEs) and bleeding profiles were documented.

Results: Dienogest therapy decreased EHP-30 scores in all assessed domains (score 0-100, lower scores indicate better HRQoL). Primarily, the "pain" domain was improved in 78.4% of patients. EAPP was reduced (score 0-10, lower scores reflect less pain), highlighted by a mean reduction of the pain score by - 4.5 points. Patients with a higher EAPP score at baseline had an increased response to dienogest (- 6.2 points mean change) compared to patients with low baseline EAPP severity (- 1.4 points mean change). Both surgically and clinically diagnosed patients described comparable pain reduction, as well as women with or without prior treatment. Drug-related TEAEs were documented for 31.5% of patients, with amenorrhoea (5.9%) and metrorrhagia (5.1%) being the most common events. The bleeding pattern was changed upon dienogest, characterized by decreased normal bleeding (84.2 to 28.8%) and increased amenorrhea (3.2 to 42.9%) at 6 months.

Conclusion: The data indicate an amelioration of HRQoL and EAPP upon dienogest therapy. No new safety signals were observed. Therefore, its use as first-line therapy for long-term management of debilitating and chronic endometriosis-associated pain represents an interesting option that remains to be further investigated.

Trial registration: Name of registry: Clinical Trials Clinicaltrials.gov registration number: NCT02425462 Registration date: 2015-04-24. Registration timing: prospective.

Keywords: Asian women; Clinical diagnosis; Endometriosis; Health-related quality of life; Pain.

Conflict of interest statement

CA is a current employee of Bayer AG, Berlin, Germany and SS is a former employee of Bayer AG. All other authors declare no competing interests.

Figures

Fig. 1

Assessment of (%) quality of life changes in EHP-30 core domains at 6 months (n = 444). Positive change indicates deterioration. Negative change indicates improvement

Fig. 2

Evaluation of changes (%) in endometriosis-associated pelvic pain (EAPP) at 6 months (n = 434) according to EAPP baseline severity (a) and type of diagnosis (b). The changes have been assessed by numeric rating scale in a 4-week recall period. Positive change indicates deterioration. Negative change indicates improvement. *Change was not evaluable for four patients due to missing baseline severity of EAPP for three patients and one lost to follow-up

Fig. 3

Changes (%) in the bleeding pattern from baseline to 6-months (6 mo.) visits. The bleeding patterns were defined as follows: 1) Normal bleeding: Regular bleeding with normal flow and duration. 2) Irregular bleeding cycle: Bleeding cycle less than 21 days or more than 35 days. 3) Amenorrhea: No menstruation during last 90 days. 4) Intermenstrual spotting / bleeding: Irregular episodes of bleeding, often light and short, occurring between otherwise fairly normal menstrual periods. Normal bleeding decreased from 84.2% at baseline to 28.8% after 6 months. Irregular bleeding cycle increased from 7.6 to 10.2%, amenorrhea from 3.2 to 42.9%, intermenstrual bleeding/spotting from 2.3 to 15.1%.