Real-world data of 197 patients treated with ulipristal acetate for uterine fibroids: PREMYA study French population main outcomes

Abstract

ObjectivesTo characterize and describe treatment with ulipristal acetate (UPA) in a preoperative setting and to evaluate the safety, effectiveness, and Health Related Quality of Life (HRQoL) outcomes in a French population treated according to standard clinical practice. Materials and methodsMulticentre, prospective, non-interventional study (PREMYA) of patients diagnosed with moderate to severe symptoms of uterine fibroids and undergoing a preoperative treatment with UPA 5mg (Esmya®). Patients were followed for a total of 15months (3months UPA treatment and 12months after). Data were collected approximatively every 3months according to centre usual visit schedule. ResultsA total of 206 women were enrolled in France, of whom 197 were found to be eligible for data analysis. Physicians’ assessments of patients’ overall symptomatic changes, as measured on the Clinical Global Impression-Improvement (CGI-I) scale, indicated that 83.7% of patients were improved at end of treatment (month 3). On the patients’ treatment benefit scale (PTBS), 94.7% of patients reported an improvement. These 2 measurements, pain and quality of life, remained improved after treatment cessation and during the entire period of follow-up. Only 58.4% of patients underwent surgery within the timeframe of the study follow-up of which the majority were of a conservative/minimal invasive nature. ConclusionMany patients did not undergo surgery during the planned 12months follow-up period after treatment whereas all patients had an indication of surgery. All measurements of treatment outcome were markedly improved by 3 months of UPA 5mg treatment. Clinical trial numberNCT01635452.