Sequential treatment with relugolix combination therapy in women with symptomatic uterine fibroids that were inadequately managed with 52 mg levonorgestrel intrauterine system: the first report

Background This is the first report aimed to evaluate the clinical impact and safety of sequential treatment with relugolix combination therapy (relugolix CT) in women with symptomatic uterine fibroids that were inadequately managed with 52 mg levonorgestrel intrauterine system (LNG-IUS) monotherapy.

The patients included four women aged 45–52 (mean: 48) years with symptomatic uterine fibroids, sometimes with coexisting adenomyosis, and bleeding persistence despite treatment with the LNG-IUS (52 mg) contraceptive for more than 6 months. The intervention included the combined use of LNG-IUS (52 mg) and relugolix CT (relugolix 40 mg + oestradiol 1 mg + norethisterone acetate 0.5 mg daily).

All women (100%) reported complete resolution of bleeding and improved quality of life following the initiation of relugolix CT while maintaining LNG-IUS (52 mg) in place as a contraceptive. No adverse events were observed. The mean followup was 11.2 (range 3–24) months, and satisfaction with the combined treatment was reported as 9.4/10.

The sequential combination of the contraceptive LNG-IUS (52 mg) and relugolix CT may offer a safe, well tolerated, and effective non-surgical alternative for the management of symptomatic uterine fibroids, particularly in women who do not completely respond to a 6-month treatment with LNG-IUS (52 mg). These findings support further prospective investigation into this dual therapeutic sequential strategy for symptomatic uterine fibroids. SHORT CONDENSATION Some women with uterine fibroids during treatment with LNG-IUS 52 mg as contraceptive experience persistence of abnormal uterine bleeding. If the abnormal bleeding persists for more than 6 months of treatment with LNG-IUS 52 mg, the addition of oral relugolix combination therapy guarantees a complete resolution of symptoms, associated with a high satisfaction. The combination of LNG-IUS 52 mg and relugolix CT may represent a further evolution in the medical treatment of bleeding due to uterine fibroids, allowing the management of an increasingly higher percentage of bothersome cases. 摘要 背景 这是首项旨在评估对症状性子宫肌瘤患者采用瑞卢戈利联合(relugolix CT)序贯治疗的临床影响与安全性的报告, 这些女性此前接受了52毫克左炔诺孕酮宫内节育系统(LNG-IUS)治疗但效果不佳。 材料与方法 研究对象包括4名年龄45-52岁(平均: 48岁)的女性, 她们患症状性子宫肌瘤, 部分患者还合并子宫腺肌病。尽管她们使用左炔诺孕酮宫内节育系统(LNG-IUS, 52毫克)治疗了超过6个月, 但仍存在持续性出血。干预措施包括联合使用LNG-IUS(52毫克)和瑞卢戈利复方片剂(每日瑞卢戈利 40毫克+雌二醇1毫克+醋酸炔诺酮0.5毫克)。 结果 所有女性(100%)均在使用瑞卢戈利持续治疗(LNG-IUS 52毫克作为避孕方式持续使用)后反映出血症状完全缓解, 生活质量得到改善, 并且未观察到不良事件。本研究的平均随访时间为11.2个月(范围3-24个月), 对联合治疗的满意度评分为9.4/10。 结论 左炔诺孕酮宫内节育系统(LNG-IUS, 52毫克)与瑞卢戈利连续联合的序贯治疗可能为症状性子宫肌瘤的管理提供一种安全、耐受良好且有效的非手术替代方案, 尤其适用于于LNG-IUS(52毫克)治疗6个月后疗效不佳的女性。这些发现证明有必要对症状性子宫肌瘤的联合序贯治疗方法进行进一步的前瞻性研究。 Statement The authors certify that they have obtained all appropriate patient consent forms. The patients have given their written consent for their images and clinical informations to be reported in the journal. The patients were also ensured that their names and initials will not be published, in order to ensure anonymity. Disclosure statement G. Grandi received honoraria for sponsored lectures and participation in advisory boards from Bayer AG, Teva/Theramex, Exeltis, Organon, Italfarmaco, Opocrin and Gedeon Richter. The authors have no other relevant affiliations or financial involvement with any organisation or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Data availability statement The data that support the findings of this study are available from the corresponding author, GG, upon reasonable request.