RYEQO (rélugolix/noréthistérone/estradiol)

Key points

Favourable opinion for reimbursement in the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

What therapeutic improvement?

No clinical added value in the therapeutic strategy for the treatment of moderate to severe symptoms of uterine fibroids.

Role in the care pathway?

In the event of asymptomatic fibroids, there is no point envisaging medical treatment. With the exception of symptomatic submucosal fibroids, in which the first-line treatment is surgery, the first-line treatment of symptomatic fibroids with pain or bleeding, is symptomatic. No medical treatment for fibroid-related symptoms is effective in terms of making fibroids disappear.

The prescription of a progestogen treatment is aimed at reducing menometrorrhagia by reducing fibroid-related endometrial hyperplasia. Three progestogen-containing medicinal products are indicated in the treatment of fibroid-related functional bleeding and menorrhagia: COLPRONE (medrogestone), LUTENYL (nomegestrol), LUTERAN (chlormadinone).

A risk of meningioma has been confirmed with chlormadinone acetate (LUTERAN) and nomegestrol (LUTENYL), which increases on the basis of the dose, the treatment duration and the patient’s age. When these medicinal products are used for less than a year, the risk of meningioma is very low. Beyond this period, the risk is significantly increased. Consequently, beyond a period of one year, their prescription must be reassessed annually, with the implementation of brain MRI monitoring. Their risk/benefit ratio is considered to be favourable in women of reproductive age when the therapeutic alternatives have failed or are contraindicated in fibroid-related functional bleeding and menorrhagia before surgery.

A levonorgestrel-releasing intrauterine system (MIRENA or DONASERT) is indicated in functional menorrhagia, after investigating for and ruling out detectable organic causes. A levonorgestrel-releasing intrauterine system is contraindicated in the event of congenital or acquired abnormalities of the uterus, including fibroids if they distort the uterine cavity. Due to the increased risks of bleeding complications and expulsion, submucosal fibroids are a relative contraindication to intrauterine devices.

The proprietary medicinal products EXACYL and SPOTOF, containing tranexamic acid, are indicated in haemorrhage caused by local fibrinolysis, as is the case in menorrhagia and metrorrhagia secondary to traumatic or infectious or degenerative lesions of the uterus.

Mefenamic acid (PONSTYL) is indicated in functional menorrhagia that remains unexplained following systematic aetiological analysis and dysmenorrhoea following aetiological investigation.

According to the French national college of gynaecologists-obstetricians (CNGOF), nonsteroidal anti-inflammatories (NSAIDs) can lead to a reduction in menorrhagia, but with a lower efficacy than tranexamic acid or the levonorgestrel-releasing intrauterine system. They are effective in the event of pain related to aseptic necrobiosis of a fibroid. The prescription of NSAID treatment may be proposed to treat the symptoms of fibroids.

Three proprietary medicinal products containing GnRH agonists, GONAPEPTYL (triptorelin), DECAPEPTYL (triptorelin) and ENANTONE (leuprorelin), have an MA in the preoperative treatment of uterine fibroids to reduce their size and/or correct anaemia. They are reserved for short-term use (3 to 6 months depending on the medicinal product) in severe cases before elective surgery due to their safety profile and their effect on bone mineral density.

Non-medicinal treatments are envisaged in the event of failure of medicinal treatments.

Role of the medicinal product in the care pathway

RYEQO (relugolix / estradiol / norethisterone acetate) is a therapeutic alternative in the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. RYEQO (relugolix / estradiol / norethisterone acetate) had superior efficacy to placebo in terms of reducing fibroid-related bleeding.

In the absence of a study versus a clinically relevant comparator, it is not possible to rank RYEQO (relugolix / estradiol / norethisterone acetate) compared to the other medicinal treatments indicated in fibroid-related menorrhagia and metrorrhagia.