Uterine fibroids (UF) are the most common benign uterine tumours, estimated to occur in over 70% of women by the onset of menopause; 25% of whom will experience symptoms1. In addition to being a source of significant distress to women, they are among the most common reasons for hysterectomy, though it causes infertility in women of reproductive age.
Ulipristal acetate (UPA) has been approved in Europe for treatment preceding a surgery for UF patients experiencing symptoms (in two three-month treatment cycles) and for repeated sequential treatment for UF patients with moderate-to-severe symptoms. Limited data exist on the use of currently available treatments for UF in the UK, in particular since the introduction of UPA.
This study is a retrospective longitudinal cohort study using UK primary care data from the Clinical Practice Research Datalink (CPRD) linked to inpatient (Hospital Episode Statistics (HES)) data. The main aim of the study is to explore patient characteristics, care management and associated healthcare resource utilisation (HCRU) in adult women for new episodes of UF.
Results from this exploratory research will provide an up-to-date picture of the current practice in the management of UF within GPs' practices in the UK.
Female patients aged 18-54 years old will be identified (indexed) on their first UF-coded event.
As we want to capture treatment patterns for new episodes of UF, a pre-index period of 12 months with no UF-coded events is required. A 12-month pre-index window gives us a reasonable degree of confidence that the index date is in fact a new episode of UF.
Treatment patterns will be investigated within the 24 months post index date. Baseline characteristic will be assessed in the pre-index period and values closest to the index date will be used.
To assess the use of UPA, the study design will be modified to capture more patients prescribed UPA; the indexing period will be extended by 12 months to 36 months, and the follow-up period reduced from 24 months to 12 months.
The study will be mainly descriptive, with elements of comparative analysis between UPA vs. non-UPA patients who received other pharmaceutical treatments. Negative binomial regression models will be constructed, with elements of HCRU as the outcome, UPA vs. non-UPA as the exposure and adjusting for confounding factors outlined in section M. In addition, these regression models will adjust for patient-level differences in length of exposure.
1. Baseline demographics and clinical characteristics, including age, BMI, Charlson's comorbidity index, number of gynaecologist visits within the pre-index period
2. Treatment patterns - first Uterine Fibroids (UF) related treatment prescribed, time to treatment initiation, treatment dynamics (continuous use, discontinuation, direct switch, retreatment with index drug or another UF drug, augmentation; as detailed in section N. Data/ Statistical Analysis)
3. Resource use - complications after the first surgical treatment for UF, UF-related hospitalisations and emergency admissions within the follow-up period, number of gynaecologist visits in the follow-up period.
Nawal Bent-Ennakhil - Chief Investigator - Adelphi Real World
Rafal Jakubanis - Corresponding Applicant - Deep Sense ai
- Collaborator -
Adam Roughley - Collaborator - Adelphi Real World
Alice Wang - Collaborator - AbbVie Inc. USA (Headquarters)
James Piercy - Collaborator - Adelphi Real World
Robert Wood - Collaborator - Adelphi Real World
HES Admitted Patient Care