Zastosowanie Linzagoliksu w terapii endometriozy

Dababou S, Garzon S, Laganà AS, et al. Linzagolix: a new GnRH-antagonist under investigation for the treatment of endometriosis and uterine myomas. Expert Opinion on Investigational Drugs. 2021;30(9):903-911. doi:10.1080/13543784.2021.1957830

Vercellini P, Fedele L, Aimi G, Pietropaolo G, Consonni D, Crosignani PG. Association between endometriosis stage, lesion type, patient characteristics and severity of pelvic pain symptoms: a multivariate analysis of over 1000 patients. Human Reproduction. 2006;22(1):266-271. doi:10.1093/humrep/del339

Fauconnier A, Chapron C. Endometriosis and pelvic pain: epidemiological evidence of the relationship and implications. Human Reproduction Update. 2005;11(6):595-606. doi:10.1093/humupd/dmi029

Howard FM. Endometriosis and Mechanisms of Pelvic Pain. Journal of Minimally Invasive Gynecology. 2009;16(5):540-550. doi:10.1016/j.jmig.2009.06.017

Anaf V. Relationship between endometriotic foci and nerves in rectovaginal endometriotic nodules. Human Reproduction. 2000;15(8):1744-1750. doi:10.1093/humrep/15.8.1744

Vercellini P, Somigliana E, Viganò P, Abbiati A, Daguati R, Crosignani PG. Endometriosis: current and future medical therapies. Best Practice & Research Clinical Obstetrics & Gynaecology. 2008;22(2):275-306. doi:10.1016/j.bpobgyn.2007.10.001

Vercellini P, Somigliana E, Viganò P, Abbiati A, Barbara G, Crosignani PG. Endometriosis. Drugs. 2009;69(6):649-675. doi:10.2165/00003495-200969060-00002

Pohl O, Marchand L, Bell D, Gotteland JP. Effects of combined GnRH receptor antagonist linzagolix and hormonal add-back therapy on vaginal bleeding—delayed add-back onset does not improve bleeding pattern. Reprod Sci. 2020;27(4):988-995. doi:10.1007/s43032-020-00172-z

Soliman AM, Surrey E, Bonafede M, Nelson JK, Castelli-Haley J. Real-World Evaluation of Direct and Indirect Economic Burden Among Endometriosis Patients in the United States. Adv Ther. 2018;35(3):408-423. doi:10.1007/s12325-018-0667-3

Perricos A, Wenzl R. Efficacy of elagolix in the treatment of endometriosis. Expert Opinion on Pharmacotherapy. 2017;18(13):1391-1397. doi:10.1080/14656566.2017.1359258

Della Corte L, Barra F, Mercorio A, et al. Tolerability considerations for gonadotropin-releasing hormone analogues for endometriosis. Expert Opinion on Drug Metabolism & Toxicology. 2020;16(9):759-768. doi:10.1080/17425255.2020.1789591

Barra F, Vitale SG, Seca M, et al. The potential role of elagolix for treating uterine bleeding associated to uterine myomas. Expert Opinion on Pharmacotherapy. 2020;21(12):1419-1430. doi:10.1080/14656566.2020.1755254

Betz SF, Zhu YF, Chen C, Struthers RS. Non-Peptide Gonadotropin-Releasing Hormone Receptor Antagonists. J Med Chem. 2008;51(12):3331-3348. doi:10.1021/jm701249f

Tukun FL, Olberg DE, Riss PJ, Haraldsen I, Kaass A, Klaveness J. Recent Development of Non-Peptide GnRH Antagonists. Molecules. 2017;22(12):2188. doi:10.3390/molecules22122188

Chen C, Wu D, Guo Z, et al. Discovery of Sodium R-(+)-4-{2-[5-(2-Fluoro-3-methoxyphenyl)-3-(2-fluoro-6-[trifluoromethyl]benzyl)-4-methyl-2,6-dioxo-3,6-dihydro-2H-pyrimidin-1-yl]-1-phenylethylamino}butyrate (Elagolix), a Potent and Orally Available Nonpeptide Antagonist of the Human Gonadotropin-Releasing Hormone Receptor. J Med Chem. 2008;51(23):7478-7485. doi:10.1021/jm8006454

Miwa K, Hitaka T, Imada T, et al. Discovery of 1-{4-[1-(2,6-Difluorobenzyl)-5-[(dimethylamino)methyl]-3-(6-methoxypyridazin-3-yl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl]phenyl}-3-methoxyurea (TAK-385) as a Potent, Orally Active, Non-Peptide Antagonist of the Human Gonadotropin-Releasing Hormone Receptor. J Med Chem. 2011;54(14):4998-5012. doi:10.1021/jm200216q

Al-Hendy A, Bradley L, Owens CD, et al. Predictors of response for elagolix with add-back therapy in women with heavy menstrual bleeding associated with uterine fibroids. American Journal of Obstetrics and Gynecology. 2021;224(1):72.e1-72.e50. doi:10.1016/j.ajog.2020.07.032

Carr BR, Stewart EA, Archer DF, et al. Elagolix Alone or With Add-Back Therapy in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas. Obstetrics & Gynecology. 2018;132(5):1252-1264. doi:10.1097/aog.0000000000002933

Ali M, Chen HY, Chiang YF, Badary OA, Hsia SM, Al-Hendy A. An evaluation of relugolix/estradiol/norethindrone acetate for the treatment of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. Expert Opinion on Pharmacotherapy. 2022;23(4):421-429. doi:10.1080/14656566.2022.2030705

Donnez J, Taylor HS, Stewart EA, et al. Linzagolix with and without hormonal add-back therapy for the treatment of symptomatic uterine fibroids: two randomised, placebo-controlled, phase 3 trials. The Lancet. 2022;400(10356):896-907. doi:10.1016/s0140-6736(22)01475-1

Casati L, Ciceri S, Maggi R, Bottai D. Physiological and pharmacological overview of the gonadotropin releasing hormone. Biochemical Pharmacology. 2023;212:115553. doi:10.1016/j.bcp.2023.115553

Pohl O, Marchand L, Fawkes N, Gotteland JP, Loumaye E. Gonadotropin-Releasing Hormone Receptor Antagonist Mono- and Combination Therapy With Estradiol/Norethindrone Acetate Add-Back: Pharmacodynamics and Safety of OBE2109. The Journal of Clinical Endocrinology & Metabolism. 2017;103(2):497-504. doi:10.1210/jc.2017-01875

Donnez J, Taylor HS, Taylor RN, et al. Treatment of endometriosis-associated pain with linzagolix, an oral gonadotropin-releasing hormone–antagonist: a randomized clinical trial. Fertility and Sterility. 2020;114(1):44-55. doi:10.1016/j.fertnstert.2020.02.114

Donnez J, Becker C, Taylor H, et al. Linzagolix therapy versus a placebo in patients with endometriosis-associated pain: a prospective, randomized, double-blind, Phase 3 study (EDELWEISS 3). Human Reproduction. 2024;39(6):1208-1221. doi:10.1093/humrep/deae076

Bestel E, Gotteland JP, Donnez J, Taylor RN, Garner EI. Quality of Life Results After 52 Weeks of Treatment With Linzagolix for Endometriosis-Associated Pain [30B]. Obstetrics & Gynecology. 2020;135(1):26S-27S. doi:10.1097/01.aog.0000663200.75027.38

Donnez J, Dolmans MM. Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review. JCM. 2021;10(5):1085. doi:10.3390/jcm10051085

Marsh EE, Catherino W, Al-Hendy A, Donnez J, Bestel E, Garner E. Incidence of Mood Disorders in Women Treated With Linzagolix: 52-week Results From Two Phase 3 Trials [A106]. Obstetrics & Gynecology. 2022;139(1):31S-31S. doi:10.1097/01.aog.0000826744.44400.f7

Stewart EA, Taylor HS, Taylor RN, et al. EFFICACY AND SAFETY OF LINZAGOLIX (LGX) FOR THE TREATMENT OF HEAVY MENSTRUAL BLEEDING (HMB) DUE TO UTERINE FIBROIDS (UF): RESULTS FROM TWO PHASE 3 RANDOMIZED CLINICAL TRIALS. Fertility and Sterility. 2020;114(3):e527. doi:10.1016/j.fertnstert.2020.09.016

Keam SJ. Linzagolix: First Approval. Drugs. 2022;82(12):1317-1325. doi:10.1007/s40265-022-01753-9

ObsEva. ObsEva announces positive topline results for linzagolix 200 mg with add-back therapy in the phase 3 EDELWEISS 3 trial in patients with moderate-to-severe endometriosis-associated pain [media release]. 6 Jan 2022. https://www.obseva.com/.

Taylor H, Donnez J, Petraglia F, et al. O-135 Long term secondary efficacy of linzagolix for heavy menstrual bleeding (HMB) due to uterine fibroids (UF): 52-week results from two placebo-controlled, randomized, phase 3 trials. Human Reproduction. 2021;36(Supplement_1). doi:10.1093/humrep/deab126.060

Financial reports. ObsEva. Available from: www.obseva.com/financial-reports

Bradley LD, Marsh EE, Garner E. LINZAGOLIX MAY ADDRESS THE LONG-TERM TREATMENT NEEDS OF WOMEN WITH UTERINE FIBROIDS (UF) WHO HAVE CONTRAINDICATIONS TO HORMONAL ADD-BACK THERAPY (ABT): RESULTS FROM TWO PHASE 3 RANDOMIZED CLINICAL TRIALS. Fertility and Sterility. 2020;114(3):e527. doi:10.1016/j.fertnstert.2020.09.017

Donnez J, Dolmans MM. GnRH Antagonists with or without Add-Back Therapy: A New Alternative in the Management of Endometriosis? IJMS. 2021;22(21):11342. doi:10.3390/ijms222111342

Lessey BA, Gordts S, Donnez O, et al. Ovarian endometriosis and infertility: in vitro fertilization (IVF) or surgery as the first approach? Fertility and Sterility. 2018;110(7):1218-1226. doi:10.1016/j.fertnstert.2018.10.003

Donnez J. Women with endometrioma-related infertility face a dilemma when choosing the appropriate therapy: surgery or in vitro fertilization. Fertility and Sterility. 2018;110(7):1216-1217. doi:10.1016/j.fertnstert.2018.10.002

Becker CM, Bokor A, Heikinheimo O, et al. ESHRE guideline: endometriosis. Human Reproduction Open. 2022;2022(2). doi:10.1093/hropen/hoac009

Capezzuoli T, Vannuccini S, Mautone D, et al. Long-term hormonal treatment reduces repetitive surgery for endometriosis recurrence. Reproductive BioMedicine Online. 2021;42(2):451-456. doi:10.1016/j.rbmo.2020.09.018

Donnez O, Donnez J. Deep endometriosis: The place of laparoscopic shaving. Best Practice & Research Clinical Obstetrics & Gynaecology. 2021;71:100-113. doi:10.1016/j.bpobgyn.2020.05.006

Soliman AM, Yang H, Du EX, Kelley C, Winkel C. The direct and indirect costs associated with endometriosis: a systematic literature review. Hum Reprod. 2016;31(4):712-722. doi:10.1093/humrep/dev335