Gynecology Daily Report: 01/18/2024

An open-label, single-arm study (NCT03654274) evaluated the long-term efficacy and safety of relugolix combination therapy (CT) in women with moderate to severe endometriosis-associated pain (1). Among 1261 randomized patients, 1044 completed the pivotal studies, 802 enrolled in the long-term extension (LTE), 681 completed 52 weeks of treatment, and 501 completed 104 weeks of treatment. The study found sustained improvements in endometriosis-associated pain through 104 weeks. At Week 104, the proportion of responders for dysmenorrhea and non-menstrual pelvic pain (NMPP) was 84.8% and 75.8%, respectively. Decreases in dyspareunia and improvement in function were also sustained over 2 years. At Week 104, 91% of patients were opioid-free and 75% were analgesic-free. After an initial mean bone mineral density (BMD) loss of less than 1% at Week 24, BMD plateaued at Week 36 and was sustained for the duration of 104 weeks of treatment. This study was funded by Myovant Sciences GmbH (now Sumitomo Pharma Switzerland GmbH).

Reference

Becker CM, Johnson NP, As-Sanie S, Arjona Ferreira JC, Abrao MS, Wilk K, Imm SJ, Mathur V, Perry JS, Wagman RB, Giudice LC. Two-year efficacy and safety of relugolix combination therapy in women with endometriosis-associated pain: SPIRIT open-label extension study. Hum Reprod. 2024 Jan 18:dead263. doi: 10.1093/humrep/dead263. Epub ahead of print. PMID: 38243752.